0% found this document useful (0 votes)
0 views74 pages

WHO Study Guide

The document consists of letters from key figures involved in the DRMUN'26 conference, including the Secretary-General, Deputy Secretary-General, Under Secretary-General, and Academic Assistant, expressing their gratitude and outlining the conference's goals. The conference aims to enhance participants' diplomatic skills while addressing global health issues, particularly the influence of pharmaceutical lobbying. The letters emphasize teamwork, personal growth, and the importance of the conference in fostering discussions on critical health governance topics.

Uploaded by

cinarnazlioglu
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
0 views74 pages

WHO Study Guide

The document consists of letters from key figures involved in the DRMUN'26 conference, including the Secretary-General, Deputy Secretary-General, Under Secretary-General, and Academic Assistant, expressing their gratitude and outlining the conference's goals. The conference aims to enhance participants' diplomatic skills while addressing global health issues, particularly the influence of pharmaceutical lobbying. The letters emphasize teamwork, personal growth, and the importance of the conference in fostering discussions on critical health governance topics.

Uploaded by

cinarnazlioglu
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

I.

​ Letter from the Secretary-General

Esteemed participants of DRMUN’26,

My name is Defne Duvan, I am an 11th grade student at Doctors and i will be serving as

the Secretary-General. It is the utmost importance for me to deliver the best conference to you

all. I have been doing MUNs since 9th grade and ever since then, it was our vision as

DRMUN’26 team to host this conference, thus, holding the 1st edition of DRMUN is an honor

for us all.

With the hopes of making this conference enjoyable for the participants, we have

established an amazing academic and organization team. The environment that we aim to

provide for the participants is that they could enhance their diplomatic and social skills

confidently. DRMUN will be where participants will learn the thin balance between war and

peace. This conference proved to me that you can’t do everything on your own, instead you can

share the hardships with your friends and for that I’m grateful to my executive team, each of

them prepared this conference with their best efforts possible.

I would especially like to thank my Deputy Secretary-General Nilda, for the support she

has given to me for the conference and for our club journey, she has been by my side since the

9th grade where we attended our first MUN together. I am forever indebted to my Director

General Melis Talu who managed us to find a common ground with our needs and wants. She is

a true diplomat for that. She is also one of the first people that I’ve enjoyed MUN’s together,

hence, us delivering DRMUN’26 to you is an emotional rollercoaster for us. I also thank our

Deputy Director Generals deeply, Deva and Arsa. Deva is a very determined person and she was

able to overcome the sudden obstacles that occured while we were preparing for this conference.

As per our organization team, I am thankful for all of our heads as they have spent countless days
and nights trying to prepare the best organization just for you. I would also like to thank our

Academic and Organizational Advisors who are also graduates of our school Ipek Gunes, she

provided all the logistics working alongside our Heads; Alp Arifoglu for always being on our

side and coming to our school frequently while we were struggling; Last but definitely not the

least our brother from another father Bora Gedikli, he made DRMUN possible, he was one of the

few people that always stood by our side and gave us the courage to create such a conference.

We are forever indebted to him for opening our way to MUN’s.

I would also like to thank Enes Berk Uzun for the support that he has provided to me

even at my lowest, and Emir Hamza for getting me into crisis committees and supporting me

through 3 years. I have lost a lot and gained a few, but I am even grateful for the people who

have made me lose.

Yours Sincerely,

Defne Duvan

2
II.​ Letter from the Deputy Secretary-General

Esteemed Participants of DRMUN’26,

My name is Nilda Yiğit, and I am deeply honored to be serving as the Deputy

Secretary-General of DRMUN’26. This conference has been a dream of mine ever since 9th

grade, hence, I am filled with joy that DRMUN has become a truth. As the DRMUN team, we

have tried our best to bring you the best conference ever. During this process, I have learned

what it is to embrace differences in opinion, to stay calm even in the times of chaos, and to love

my team despite the hardships we have gone through.

I would like to start my thanks with our SG Defne, our DDGs Arşa and Deva, and our

DG Melis. I would like to especially thank Deva and Melis: Deva for always supporting me and

making me laugh even at our worst, you really are a strong girl and you deserve the world; Melis

for being my twin and partner in crime, you have always been one of my closest friends and I

owe this to the committee which is none other than the Senate and I am glad you decided to

continue your journey with me because I enjoyed every part of it, you really are a cutie pie. Next,

to our advisors who have worked endlessly regardless of their busy schedules: Bora Gedikli,

İpek Güneş, and Alp Arifoğlu. I should also mention our club advisor Senem Bal. She has been

my teacher since middle school and she is one of the sweetest teachers you can meet. She is

always open to new information and listens to us whenever we need it. I would like to thank our

Academic Team who has worked days and nights preparing the best committees for you. Among

those I must mention one person whom I originally did not intend to, Yağmur Akman. Your

enthusiasm for the conference has made me change my mind because not only did you help me

personally but also you were down to help anyone anytime we were talking about the

conference. Thank you for being my bro

3
III.​ Letter from the Under Secretary-General

Dear Delegates,

It is my great pleasure to welcome you all to the World Health Organization (WHO)

committee of DRMUN’26. My name is Delfin Soykan, and I am a first-year International

Relations student at Bilkent University. It is an honor to serve as your Under Secretary General

and guide you through our discussions on “Regulating Pharmaceutical Lobbying and Influence

in Global Health Decision-Making.”

Global health governance has become increasingly complex in the twenty-first century.

While pharmaceutical companies have played an undeniable role in advancing medical

innovation, expanding access to treatments, and responding to global health crises, their growing

influence over policy-making processes has also raised important concerns regarding

transparency, accountability, and equity. As healthcare systems become more interconnected,

questions surrounding the role of private actors in shaping international health policies have

become central to contemporary global governance debates.

Within our committee, delegates will examine the challenges and opportunities associated

with pharmaceutical lobbying and its impact on global health decision-making. Striking a

balance between encouraging innovation and safeguarding public health interests remains one of

the most pressing issues facing international organizations today. Through negotiation,

diplomacy, and critical analysis, delegates will have the opportunity to explore potential

regulatory frameworks that promote ethical governance while maintaining effective cooperation

between public institutions and private stakeholders.

I believe that this study guide will provide you with a strong foundation for

understanding the agenda item and its broader implications. However, I strongly encourage all

4
delegates to conduct additional research and familiarize themselves with the positions of their

assigned countries. Doing so will not only enrich our debates but also contribute to a more

dynamic and productive committee experience.

I would like to express my sincere gratitude to the Secretariat and the entire DRMUN’26

team for their dedication and hard work in making this conference possible. Their commitment

and efforts have been invaluable throughout the preparation process. Also I would like to deliver

my deepest thanks to my Academic Assistant Uygar Ergenç, without him this committee would

not be possible.

I wish you all the best in your preparations and look forward to meeting each of you at

DRMUN’26. Should you have any questions regarding the committee or the study guide, please

do not hesitate to contact me.

Best Regards,

Delfin Soykan, Under Secretary General

[Link]@[Link]

5
IV.​ Letter from the Academic Assistant

Greetings, esteemed delegates.

“I am your Academic Assistant, Uygar ERGENÇ, and I am a 11th grader at Jale Tezer

Collage. First and foremost, I would like to thank Delfin Soykan for inviting me to DRMUN ’26,

the Executive and Organisation Teams for organising this wonderful and valuable conference,

and everyone who has supported and taught me throughout my MUN journey without expecting

anything in return.

We have prepared this study guide to offer you new perspectives and to help you learn.

Reading it will be to your benefit; however, in this hectic and oppressive capitalist world,

we—especially as young people—often cannot spare enough time for ourselves and our hobbies.

For this reason, if you are only going to glance through the guide briefly, I recommend focusing

on the ‘Questions to be Addressed’ section and then the ‘Current Status’ section, rather than

attempting to summarise the whole document.

I believe that MUN conferences add so much to our lives. They certainly have to mine.

The 32 experiences I’ve had and the new friends I’ve made are truly wonderful. Gaining a grasp

of world diplomacy and being in such environments at this age is genuinely beneficial and

enjoyable. Since the things I enjoy most in life have come together, what could be better than

MUN? Communication, Politics, Policy and History

If you have any questions, please feel free to reach out via your preferred channel. I’ve

provided my contact details below

+90 551 028 1990

@uygar__gnc

madhenk13@[Link]

6
1. Terminology and Key Words.................................................................................................... 8
2. Introduction to the Committee............................................................................................... 17
2.1. History...............................................................................................................................17
2.2. Scope.................................................................................................................................19
2.3. Membership...................................................................................................................... 20
2.4. International Mandate....................................................................................................... 21
2.5. Non Governmental Organizations (NGO’s)..................................................................... 23
2.5.1. Médecins Sans Frontières (MSF) Access Campaign...............................................23
2.5.2. Health Action International (HAI)...........................................................................23
2.5.3. Third World Network (TWN).................................................................................. 24
2.5.4. People's Health Movement (PHM).......................................................................... 24
2.5.5. Corporate Accountability.........................................................................................25
2.5.6. Transparency International Health Initiative........................................................... 26
2.5.7. Oxfam International................................................................................................. 26
2.5.8. Access to Medicine Foundation...............................................................................27
2.5.9. Initiative for Medicines, Access and Knowledge (I-MAK).....................................28
2.5.10. Knowledge Ecology International (KEI)............................................................... 28
2.5.11. Treatment Action Campaign (TAC).......................................................................29
3. Introduction to the Agenda Item: Regulating Pharmaceutical Lobbying and Influence in
Global Health Decision-Making................................................................................................. 30
3.1. Definition and scope of pharmaceutical lobbying............................................................ 30
3.2. Key actors and stakeholders in global health standarts.................................................... 31
3.3. Why that issue is important for global health governance................................................33
3.4. The WHO’s role in holding the industry’s effect..............................................................34
4. History and Past Events.......................................................................................................... 36
4.1. Early Pharmaceutical Industry Involvement in Global Health Policy..............................36
4.2. Landmark Cases of Lobbying and Regulatory Capture....................................................37
4.3. Earlier WHO declarations and Reform Tries....................................................................39
5. Current Status.......................................................................................................................... 40
5.1. Usable Transparency Mechanisms and Limitations......................................................... 40
5.2. Regional Strategiesto Pharmaceutical Lobbying Regulation........................................... 42
5.3. Ongoing Debates Within the WHO and Member States.................................................. 43
5.4. Current Arguments and High-Statue Cases...................................................................... 45
5.5. Measurement Indicators and Cooperative NGO’S........................................................... 46
6. Country Stances....................................................................................................................... 48
7. Questions to be Addressed...................................................................................................... 66
8. References................................................................................................................................. 66

7
1.​ Terminology and Key Words

Access Consortium A group of five national medicine regulatory agencies from

Australia, Canada, Singapore, Switzerland and the United Kingdom that work together to review

and approve new medicines faster. Instead of each country running its own separate review, they

share work and make joint decisions, which helps patients in all five countries access new

treatments more quickly.,

African Medicines Agency (AMA) An agency established by the African Union to

strengthen pharmaceutical regulation across the African continent. Its goal is to replace the

current situation where each of the 55 African countries runs its own separate regulatory system

with a more unified framework that can evaluate and approve medicines for the whole continent

at once.

African Medicines Regulatory Harmonization (AMRH) An initiative that works

toward aligning pharmaceutical regulation rules across African countries so that medicines do

not need to go through a completely separate approval process in each country. It is the

foundation on which the African Medicines Agency is being built.

AIFA (Agenzia Italiana del Farmaco) The Italian national medicines regulatory agency,

responsible for evaluating, approving and monitoring pharmaceutical products in Italy. It also

oversees medicine pricing and reimbursement policies at the national level.

Alma-Ata Declaration A political statement adopted in 1978 at a major international

conference in what is now Kazakhstan. It declared that primary healthcare is a fundamental

human right and called on governments to work toward universal access to basic health services.

8
It was a landmark commitment to health equity but was largely undermined by economic reform

pressures in the following decade.

AMGROS The Danish hospital procurement agency responsible for buying medicines

for Danish hospitals. It has developed joint procurement initiatives with other Nordic countries

and has been a leader in applying environmental standards as criteria in medicine procurement

tenders.

Assessed Contributions The regular, mandatory fees that all WHO member states are

required to pay. These are calculated based on each country's economic size and population.

Unlike voluntary contributions, assessed contributions are not tied to specific programs and give

the WHO more freedom to decide how the money is used.

Binding Treaty A formal agreement between countries that carries legal force. Countries

that sign and ratify a binding treaty are legally required to implement its provisions, as opposed

to non-binding recommendations or guidelines that countries may choose to follow or ignore

without legal consequences. The WHO Framework Convention on Tobacco Control is the only

binding international public health treaty the WHO has ever produced.

Compulsory Licensing A government-authorized permission that allows a country to

produce or import a patented medicine without the consent of the company that holds the patent

on it. This is a legal right recognized under the TRIPS Agreement, particularly when public

health emergencies make affordable access to a medicine a national priority. The Doha

Declaration of 2001 confirmed this right explicitly.

9
Conflict of Interest A situation where a person's financial or professional ties to an

outside party, such as a pharmaceutical company, could influence their professional judgment in

ways that do not serve the public interest. In the WHO context, this refers primarily to situations

where experts involved in writing health guidelines have financial relationships with companies

that make the products those guidelines cover.

Declaration of Interests A form that experts are required to fill out before participating

in WHO technical consultations or advisory processes. It requires them to disclose any financial

or professional ties they have to companies or organizations that might benefit from the decisions

being made. The declared information is then reviewed by WHO staff to determine whether

participation would create an unacceptable conflict of interest.

Doha Declaration on TRIPS and Public Health A political statement adopted by World

Trade Organization member countries in 2001 in Doha, Qatar. It confirmed that the TRIPS

Agreement does not prevent governments from using measures such as compulsory licensing to

protect public health, particularly for access to medicines. It was a significant victory for

developing countries and health advocates who had argued that patent rules were blocking

affordable medicine access.

ECOWAS (Economic Community of West African States) A regional organization

made up of fifteen West African countries that promotes economic integration and cooperation

across the region, including in areas such as pharmaceutical regulatory harmonization and

medicine supply management.

Essential Medicines List A document published by the WHO since 1977 that identifies

the medicines considered most important for addressing the healthcare needs of the majority of

10
the world's population. It prioritizes medicines that are proven to work, widely needed and

available in affordable generic versions. It is updated regularly and is used by governments,

particularly in low-income countries, to guide medicine procurement decisions.

EU Transparency Register (Interinstitutional Agreement on a Mandatory

Transparency Register) A registration system covering the European Parliament, the European

Commission and the Council of the European Union, which since 2021 requires organizations

that wish to influence EU policymaking to register and disclose their lobbying activities and

expenditures. Pharmaceutical companies operating in Brussels must participate.

Evergreening A practice used by some pharmaceutical companies to extend their period

of market exclusivity beyond the original patent term by filing multiple additional patents on

small variations of an existing drug. These secondary patents may cover new dosages, new

formulations or minor modifications of the original compound, even when there is no meaningful

clinical improvement. This delays the entry of cheaper generic versions into the market.

Framework of Engagement with Non-State Actors (FENSA) A set of rules adopted by

the WHO in 2016 that governs how organizations outside of government, including

pharmaceutical companies, academic institutions and civil society groups, can engage with the

WHO's work. It includes provisions intended to prevent conflicts of interest from arising when

private sector actors participate in WHO processes.

Generic Medicine A medicine that contains the same active ingredient as an originator

branded product, in the same dose and form, and that works in the same way. Generic medicines

become available after the original patent on a medicine expires. They are typically much

11
cheaper than branded versions because the manufacturer does not need to recover research and

development costs.

Haute Autorité de Santé (HAS) France's national authority for health technology

assessment, which evaluates the medical benefits of new medicines and other health

technologies. Its assessments inform decisions about which medicines will be reimbursed by the

French national health insurance system and at what price.

Health Technology Assessment (HTA) A systematic process used by governments and

health authorities to evaluate the clinical effectiveness, cost-effectiveness and broader impact of

new medicines, medical devices or other health technologies. It is used to decide whether a new

treatment provides enough added benefit to justify its cost and whether it should be publicly

funded or reimbursed.

IFPMA (International Federation of Pharmaceutical Manufacturers and

Associations) The main global trade association representing the research-based pharmaceutical

industry. It coordinates the positions of large originator pharmaceutical companies and their

national associations in international forums including the WHO, and advocates for policies that

protect pharmaceutical patents and innovation incentives.

Import Substitution An economic policy in which a country prioritizes producing goods

domestically rather than importing them from abroad. In the pharmaceutical context, it refers to

government policies that support or require the replacement of imported medicines with

domestically manufactured alternatives, typically to reduce dependence on foreign supply chains

and strengthen national pharmaceutical capacity.

12
International Nonproprietary Names (INN) A standardized naming system maintained

by the WHO that assigns a single official generic name to every pharmaceutical substance. This

system ensures that healthcare professionals, regulators and patients in different countries and

languages are all referring to the same compound when they discuss a particular medicine,

regardless of what brand name it is sold under.

Lobbying Disclosure Act The main United States federal law regulating lobbying

activities. It requires individuals and organizations that lobby federal government officials to

register and report their activities and expenditures. However, its definition of lobbying is narrow

and excludes many forms of industry influence such as funding academic research, supporting

patient advocacy organizations and informal relationship-building with regulatory agency staff.

Most Favored Nation (MFN) Pricing A pricing policy requiring that a seller charge a

buyer no more than the lowest price it charges any other buyer for the same product. In the

pharmaceutical context, the Trump administration's MFN executive order required that US drug

prices for certain branded medicines be no higher than the lowest price charged in comparable

developed countries, based on the argument that Americans were subsidizing lower prices in

other markets.

Nordic Pharmaceutical Forum A collaborative forum involving Nordic countries

including Denmark, Norway and Sweden, used for joint pharmaceutical procurement initiatives

and policy coordination. It has been used to conduct shared medicine tenders and to pilot

innovative procurement criteria including environmental standards.

Open Payments Database A publicly accessible database maintained by the United

States federal government under the Affordable Care Act of 2010. It contains records of

13
payments made by pharmaceutical and medical device manufacturers to physicians and teaching

hospitals, above a minimum reporting threshold. The database is searchable online and is used by

journalists, researchers and the public to identify financial relationships between industry and

healthcare professionals.

Originator Company A pharmaceutical company that invests in developing a genuinely

new drug through its own research and development. These companies hold patents on the

medicines they develop, which give them exclusive rights to manufacture and sell the product for

a set period of time so they can recover their research and development costs before cheaper

generic versions are allowed to enter the market.

Pandemic Accord (WHO Pandemic Agreement) An international agreement under

negotiation since 2021, aimed at strengthening the world's ability to prevent, prepare for and

respond to future pandemics. Key contested issues include how medical countermeasures such as

vaccines and treatments will be shared equitably during emergencies, whether pharmaceutical

companies will be required to share technology or accept mandatory licensing in crisis situations

and how pathogen samples and associated benefits will be managed between countries.

Patent A legal right granted to an inventor or company that gives them exclusive control

over the production and sale of a new product or process for a set period, typically twenty years

in the pharmaceutical context. Pharmaceutical patents prevent other companies from making

generic versions of a new medicine until the patent expires, allowing the originator company to

charge prices high enough to recover its research and development investment.

Patented Medicine Prices Review Board (PMPRB) A Canadian federal regulatory

body that sets ceilings on the prices that pharmaceutical companies can charge for patented

14
medicines in Canada. It is one of the mechanisms through which Canada negotiates medicine

prices and monitors pharmaceutical pricing practices domestically.

Regulatory Capture A situation in which an industry gains enough influence over the

regulatory body that is supposed to oversee it that the body begins serving the industry's interests

rather than the public interest it was created to protect. In global health, it describes a concern

that pharmaceutical companies have gained sufficient access to and influence over WHO

processes that the organization's decisions sometimes reflect commercial priorities rather than

public health evidence.

Section 232 Tariffs Tariffs imposed by the United States government under Section 232

of the Trade Expansion Act, which allows the president to restrict imports that threaten national

security. In 2025 and 2026, the Trump administration used or threatened Section 232 tariffs on

pharmaceutical imports as leverage in negotiations with drug companies and foreign

governments over pricing and domestic manufacturing commitments.

Sofosbuvir A direct-acting antiviral medicine developed by the US company Gilead

Sciences that is highly effective at treating hepatitis C infection. It can be manufactured at very

low cost per treatment course but was priced at tens of thousands of dollars per course in

high-income markets. The gap between its production cost and its market price, and Gilead's

efforts to prevent developing countries from using compulsory licensing to produce cheaper

versions, made it one of the most frequently cited examples in debates about pharmaceutical

pricing and access.

15
TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property

Rights) A multilateral agreement administered by the World Trade Organization that sets

minimum standards for intellectual property protection, including pharmaceutical patents, across

all WTO member countries. Negotiated in the early 1990s as part of the Uruguay Round of trade

talks, TRIPS requires all member states to provide patent protection for pharmaceutical products

for at least twenty years. Its effects on access to medicines in developing countries became

highly controversial and led to the Doha Declaration of 2001.

Voluntary Contributions Funding given to the WHO by member states, foundations or

other donors on a discretionary basis, above and beyond mandatory assessed contributions. Most

voluntary contributions are earmarked, meaning donors specify in advance which programs or

disease areas the money must be spent on. Because voluntary contributions now account for

approximately eighty percent of the WHO's total budget, they give large donors significant

influence over the organization's work priorities.

WHO-Listed Authority (WLA) A designation granted by the WHO to national

medicines regulatory agencies that demonstrate they meet the highest international standards for

pharmaceutical regulation. Agencies with WLA status are recognized globally as credible

regulatory references, meaning that other countries can rely on their assessments when making

their own medicine approval decisions. This reduces duplication and helps improve medicine

access in countries with less developed regulatory systems.

WHO Prequalification Programme A WHO program that evaluates the quality, safety

and effectiveness of medicines, vaccines and other health products intended for use in global

health procurement programs, particularly in low and middle-income countries. Products that

16
pass prequalification are eligible for purchase by international health organizations and programs

such as UNICEF and the Global Fund, providing assurance to buyers that the products meet

acceptable standards.

World Health Assembly The main decision-making body of the WHO, made up of

representatives from all 194 member states. It meets every year in Geneva and functions as the

organization's governing parliament. It is responsible for approving the WHO's budget, setting

major policy directions and electing the members of the Executive Board.

2.​ Introduction to the Committee

2.1.​ History​

April 7, 1948 marks the day the World Health Organization - often called WHO - began

operating. Each year, that date becomes World Health Day. Two years before its launch, nations

met in New York during an International Health Conference. At that meeting, delegates from 61

countries signed what would become the group’s guiding document: its Constitution. This wasn’t

built out of thin air. A prior effort, tied to the League of Nations, already handled global health

matters starting in 1923. Money troubles plagued the first group, plus it held little actual power

over decisions. Built on what came before, the new WHO took over nearly all those duties, now

backed by a far wider role to act.

Years back, the group first tackled illnesses jumping between countries - ones no nation

could stop by itself. Smallpox disappearing worldwide stands out - the triumph crowned in 1980

following years of shots and teamwork across continents. That win still holds: never again has a

sickness vanished entirely because people joined forces on purpose. Other battles emerged too,

17
against polio and TB, starting around then - but these turned messy, dragging into today’s

scattered fights.

Change arrived sharply in 1978 when health leaders met in Alma-Ata, a city now part of

Kazakhstan. There, they agreed: care for common illnesses must belong to everyone, regardless

of wealth. Such an idea carried weight back then, pushing the WHO into bolder territory - health

as something owed, not earned. Yet that ideal frayed within ten years, worn down by outside

forces. Throughout the 1980s, nations with little money had to follow strict economic plans

shaped by global lenders such as the World Bank and IMF. Most of these programs slashed

government spending, yet health care seldom escaped untouched. Powerless and lacking backing

from leaders, the WHO couldn’t stop it - its grip on shaping worldwide health direction clearly

fading at that time.

When the 2000s began, what had been going on behind the scenes could no longer stay

hidden. SARS appeared in 2003, moving fast through Asia and beyond, revealing how late the

WHO reacted when alarms should have sounded. Then came Ebola in West Africa in 2014 - a

blow that cut deeper than before. The size of the disaster exposed weak spots in the WHO’s

ability to act during emergencies. Afterward, trust from countries around the world was left

shaken, never quite recovering its earlier footing. One event sped up talks inside the group that

had barely moved before. Then another pushed them faster. Money questions started gaining

ground - where it comes from, who decides where it goes. Attention turned to power shifts,

especially whose voice matters most when choices are made. Big players from business, drug

makers among them, suddenly faced sharper looks. Their role began drawing harder questions.

These points took center stage. They still do now.

18
2.2.​ Scope

Health work guided by WHO touches almost all parts of worldwide medical life. While

shaping global norms, it builds guidance for patient care alongside pushing proven methods into

policy. Countries receive backing to grow stronger local clinics and improve access through

tailored support structures. When a crisis hits, shared efforts get organized under its coordination

umbrella. A landmark moment came in 2003 - tobacco control gained teeth through a firm world

pact. That agreement stands alone as the one enforceable health rule ever launched from within

the agency. What matters most is the term 'binding'. When nations sign off on the treaty, it forces

them to act - law steps in, not just advice floating by with no consequence. Following through

becomes a duty, not an option someone might skip.

For medicines and drug-related matters, the WHO handles multiple roles that overlap in

practice. Starting back in 1977, its Essential Medicines List has guided countries on which

treatments to buy and distribute - updated often to stay current. This selection favors drugs

shown effective, commonly required, sold cheaply as generics. On another front, the WHO

checks if medical supplies meant for poorer nations live up to basic levels of safety,

performance, quality through its Prequalification Programme. Though separate tasks, both efforts

shape how medicine reaches people. Most people never think about how drug names work across

borders. Yet it matters most for treatments in global campaigns against diseases like HIV, TB or

malaria - choices made here reach millions. Picture a doctor in Nairobi using the same exact term

as one in Jakarta. That clarity comes from a naming method managed by the World Health

Organization. Each medicine gets one clear title, no matter the country. Confusion drops when

everyone says the same name, writes it plainly, means the same compound.

19
It’s key to remember the WHO lacks authority to make countries obey its advice. Each

nation keeps complete control over its public health decisions. So while the agency may suggest

actions, share guidelines, set benchmarks, or push leaders through persuasion, actual

enforcement stays out of reach. This setup becomes especially relevant when considering how

drug industry interests might shape what the organization does - or doesn’t do. Most countries

protect their own drug makers, which limits what the WHO can do. Instead of enforcing rules, it

must work through shared agreements and careful talks. Power lies with national governments,

not international agencies. Big medicine often shapes policy more than public health goals.

Decisions come slowly when profits are involved. Cooperation depends on goodwill, not

authority.

2.3.​ Membership

194 nations belong to the WHO today - placing it within reach of nearly every country on

Earth. Not limited only to UN members, areas without full recognition may still seek entry

through an alternate path if they meet certain criteria. Delegates arrive each spring in Geneva,

drawn not by ceremony but duty, gathering where global health choices take shape. This group,

known as the World Health Assembly, acts much like a governing council shaped by many

voices. Policy shifts begin here; money matters get settled too. Between these yearly meetings,

smaller leadership teams guide operations, picked directly by the larger body when votes

conclude.

Who pays for the World Health Organization? That detail seldom gets attention, yet it

shapes how the agency operates. Countries chip in through set fees tied to their economy and

number of people. These budgets arrive regularly, forming a stable base. Yet they account for just

about one fifth of the full budget. Most money flows in another way - gifts offered voluntarily by

20
nations, charities, or private backers. Such support makes up nearly everything else. Most free

donations come with strings attached - donors decide ahead of time which programs or illnesses

get funded. That setup lets big donors steer the WHO’s focus far more than their official vote

share at the World Health Assembly might imply.

Outside government circles, the WHO links up with various groups - universities sit

alongside advocacy networks and business firms. Firms making medicines count among those

involved. A set of guidelines rolled out in 2016 shapes how such non-government players take

part. Known as the Framework of Engagement with Non-State Actors, it draws boundaries for

involvement. Guarding against divided loyalties forms one key aim within its lines. It occurs

when personal connections - like money or work links to drug makers - might sway decisions

away from what helps everyone. Some people worry the rules made in 2016 don’t go far enough

to prevent bias. Because those businesses bring skills and funding to WHO discussions, they gain

access easily. Yet oversight remains light. Experts watching global health systems say stronger

limits should apply. Influence can slip in quietly, even during well-meaning talks. Rules meant to

block unfair advantage often lack teeth. Behind closed doors, priorities may shift without notice.

Who benefits? Not always the public. Weak safeguards leave room for doubt.

2.4.​ International Mandate

Right off the bat, the WHO’s job description comes straight from its founding rules.

Health as a basic human claim shows up bold in the first lines - still stirs debate now. It says

everyone gets to reach the best possible well-being, no matter skin shade, faith, ideology, cash

level, or class rank. That idea shifts ground completely: health isn’t something you trade for, nor

charity handed down by officials. Instead, it belongs to each person just by existing, full stop.

This stance pulls the agency toward justice in care access, whether convenient or not. And that

21
aim often crashes headfirst into drug industries pricing pills based on profit ceilings instead of

public need.

Not everything the WHO does comes from thin air. Its job includes guiding global efforts

when it comes to health matters. Working together with parts of the UN and similar bodies

occurs often, especially where goals overlap. Support flows to national governments so they can

strengthen how healthcare runs within borders. When crises hit, help shows up through expert

guidance. Another part of the rulebook encourages ties with science-based networks and skilled

associations tied to wellness fields. That particular clause opened doors for working with

medicine makers, since those companies hold knowledge and production skills connected to

public health tasks the agency lacks internally.

Inside this mission, a clear strain exists - one straightforward to outline but hard to fix.

Acting as protector of worldwide well-being means ensuring health benefits reach every person,

regardless of wealth. Yet reliance remains heavy on drug makers for vital details - findings from

studies, trials, inner workings of medicine creation. These firms operate first as profit-driven

entities; law binds them to investors more than communities. Their duty leans toward financial

gain, not broad healing across nations. At times these two interest groups overlap. Other

moments they clash hard. The way WHO handles that push and pull matters. Right now experts

are unsure if the handling is good enough. Guidelines around how decisions get made add

another layer. This entire knot sits at the heart of what the committee dives into.

22
2.5.​ Non Governmental Organizations (NGO’s)

2.5.1.​ Médecins Sans Frontières (MSF) Access Campaign

Médecins Sans Frontières, also known as Doctors Without Borders, is a medical

humanitarian organization that provides emergency healthcare in conflict zones and disease

outbreak areas around the world. Its Access Campaign, launched in 1999, is the branch of MSF

dedicated specifically to the politics of medicine access. The Access Campaign does not just

deliver medicines. It challenges the pricing practices and patent policies of pharmaceutical

companies through public advocacy, legal interventions and participation in international

negotiations. MSF was one of the leading civil society voices behind the Doha Declaration of

2001, which confirmed that governments have the right to produce or import cheaper generic

versions of patented medicines when public health requires it. Today the Access Campaign is

actively involved in the Pandemic Accord negotiations and continues to push back against

pharmaceutical company positions at the WHO. Delegates should expect MSF to argue

consistently for weaker patent protections, stronger compulsory licensing rights and greater

transparency in pharmaceutical pricing.

2.5.2.​ Health Action International (HAI)

Health Action International is a non-profit organization based in Amsterdam, the

Netherlands, founded in 1981. It holds official non-state actor status at the WHO, which means it

is formally recognized and can participate in certain WHO processes directly. HAI works on

expanding access to essential medicines through research, policy analysis and advocacy. Its areas

of focus include the pricing of insulin in low and middle-income countries, treatment for

snakebite envenoming, and European pharmaceutical policy. HAI has been involved in WHO

23
processes for decades and has produced detailed research on topics including medicine pricing

transparency, the marketing of pharmaceutical products and conflicts of interest in clinical

guideline development. Delegates can treat HAI as a technically credible source of analysis on

pharmaceutical policy questions, particularly those involving medicine access and pricing in

vulnerable populations.

2.5.3.​ Third World Network (TWN)

The Third World Network is an international research and advocacy organization based in

Penang, Malaysia, with offices and partner organizations in many other countries. It focuses

primarily on trade, development and environment issues from the perspective of low and

middle-income countries. In the pharmaceutical policy space, TWN is best known for its work

on intellectual property rules and their effects on medicine access. The organization provides

detailed legal and technical analysis of trade agreement negotiations, including those involving

pharmaceutical patents, and it has been one of the most consistent voices in WHO and WTO

processes arguing for policy frameworks that give developing countries more flexibility to

protect public health over commercial interests. TWN also provides direct analytical support to

delegations from low and middle-income countries in international negotiations, which helps to

partially close the resource gap between those delegations and the better-staffed missions of

wealthier states. Delegates from developing countries in particular should be aware of TWN's

work.

2.5.4.​ People's Health Movement (PHM)

The People's Health Movement is a global network of grassroots health activists, civil

society organizations and academic institutions, founded in 2000 at a meeting in Bangladesh. It

24
currently has active groups in more than 70 countries. PHM operates from a rights-based

framework, meaning it treats access to healthcare as a human right rather than a market service.

The organization publishes a document called the Global Health Watch, which is an alternative

to official WHO global health reports and is produced by researchers and activists from around

the world. The Global Health Watch examines not only health statistics but the political and

economic forces that shape them, including the role of pharmaceutical companies in global

health governance. PHM has been consistently critical of corporate influence over the WHO and

has produced detailed analyses of how that influence operates in practice. Delegates interested in

systemic critiques of the current global health governance model, particularly from a developing

country perspective, will find PHM's publications relevant.

2.5.5.​ Corporate Accountability

Corporate Accountability, formerly known as Corporate Accountability International, is a

US-based non-profit organization founded in 1977. It is one of the older organizations in this

space and has a track record of running sustained campaigns against specific corporations and

industries. Its most well-known early campaign contributed to the adoption of the WHO's

International Code of Marketing of Breast-milk Substitutes in 1981, which was one of the first

major international efforts to regulate the marketing practices of a commercial industry in a

public health context. Today, Corporate Accountability focuses heavily on tobacco, food and

pharmaceutical industries. In the pharmaceutical policy area, the organization monitors and

documents how drug companies engage with the WHO, tracks the networks through which

industry preferences enter international policymaking and runs public advocacy campaigns

aimed at strengthening the WHO's independence from commercial influence. It is one of the few

25
organizations that explicitly names specific companies and specific instances of lobbying when it

publishes its findings.

2.5.6.​ Transparency International Health Initiative

Transparency International is a global anti-corruption organization that works across

many sectors. Its Health Initiative is the branch specifically focused on corruption, accountability

and transparency within health systems. In the pharmaceutical sector, the Health Initiative has

produced country-level assessments examining how corruption affects medicine procurement,

how industry payments to healthcare professionals influence prescribing behavior and how

conflicts of interest operate within drug regulatory agencies. The organization has also published

analysis on clinical trial transparency, examining how selective reporting of trial results, meaning

publishing positive outcomes while suppressing negative ones, distorts the evidence base used in

medical decision-making. For delegates, Transparency International's work is useful because it

approaches pharmaceutical lobbying not just as a policy or trade issue but as a governance and

integrity issue, connecting it to broader discussions about institutional accountability.

2.5.7.​ Oxfam International

Oxfam is a well-known international development and humanitarian organization

operating in more than 90 countries. While its work covers many areas beyond health, its

pharmaceutical policy advocacy has been significant and well-publicized. Oxfam has

consistently challenged pharmaceutical company patent policies and pricing practices,

particularly in relation to medicines for HIV, tuberculosis, cancer and COVID-19. During the

COVID-19 pandemic, Oxfam published widely cited research documenting the extent to which

public funding had contributed to vaccine development and arguing that this public investment

26
had not been matched by public access, particularly in low and middle-income countries. The

organization also campaigns on the role of high-income governments in supporting

pharmaceutical company positions at the expense of developing country interests in international

negotiations. Delegates should expect Oxfam to push for stronger price transparency

requirements, mandatory technology transfer provisions and a fundamental rethinking of how

pharmaceutical research and development is financed globally.

2.5.8.​ Access to Medicine Foundation

The Access to Medicine Foundation is a Netherlands-based non-profit organization that

publishes a biennial index ranking the world's largest pharmaceutical companies on their policies

and practices related to medicine access in low and middle-income countries. The index uses a

consistent methodology covering areas including pricing, intellectual property policy, research

and development priorities, transparency and access programs. Because the same companies are

assessed across multiple editions, the index permits for tracking of whether individual

companies are improving or declining on access-related commitments over time. It also creates a

form of accountability through public comparison, since companies that score poorly in the index

are named and their specific failures documented. The foundation has formal relationships with

institutional investors who use the index in their decision-making about whether to engage with

pharmaceutical companies on access issues. Unlike some of the more confrontational

organizations in this space, the Access to Medicine Foundation places itself as a constructive

actor working to incentivize better industry behavior rather than simply criticizing it.

27
2.5.9.​ Initiative for Medicines, Access and Knowledge (I-MAK)

I-MAK is a US-based global non-profit organization co-founded by a patient advocate

and an intellectual property lawyer, which gives it a distinctive combination of legal expertise

and patient-centered focus. The organization's main work involves analyzing pharmaceutical

patent practices, particularly what researchers call "evergreening," which is the practice of

companies filing multiple secondary patents on small variations of a current drug to extend their

period of market exclusivity well beyond the original patent term. I-MAK has produced detailed

patent landscape analyses for several major drugs, documenting how this practice delays generic

competition and keeps prices high. The organization participates in trade negotiations and

international health governance processes where intellectual property rules are discussed and

provides legal analysis to support governments that want to challenge pharmaceutical patent

claims in court or through compulsory licensing mechanisms. Delegates interested in the

intellectual property dimensions of pharmaceutical lobbying will find I-MAK's technical

resources particularly useful.

2.5.10.​ Knowledge Ecology International (KEI)

Knowledge Ecology International is a small but highly influential NGO based in

Washington DC that focuses on the relationship between intellectual property rules and access to

knowledge, with a strong emphasis on pharmaceutical patents and medicine access. KEI is

known for producing extremely detailed technical analysis of treaty language, patent databases

and pharmaceutical pricing in ways that are accessible to policymakers and negotiators. It has

been involved in WHO processes, WTO negotiations and a range of bilateral and multilateral

trade agreement discussions for decades. KEI maintains detailed public databases of compulsory

28
licensing cases worldwide and publishes analysis on how pharmaceutical companies use patent

systems in different countries. Its founder and director, James Love, has been one of the most

consistently present civil society voices in international pharmaceutical policy negotiations. For

delegates who need to understand the legal and technical details of patent rules and how they

affect medicine access, KEI's published work is among the most reliable sources available.

2.5.11.​ Treatment Action Campaign (TAC)

The Treatment Action Campaign is a South African civil society organization founded in

1998, during a period when HIV and AIDS was devastating communities across sub-Saharan

Africa and the antiretroviral drugs that could treat the disease were priced far beyond what most

patients could access. TAC's campaigns, including its legal challenges to pharmaceutical

companies and the South African government, were central to the global effort to establish that

countries have the right to access affordable HIV treatment and to use compulsory licensing

when patents block that access. The organization's work contributed significantly to the

international pressure that led to the Doha Declaration of 2001. TAC remains active in South

African health policy and in international advocacy on medicine access, and its history is one of

the most compelling examples in the literature on how civil society mobilization can shift

pharmaceutical policy outcomes in favor of patients rather than commercial interests. Delegates

should be familiar with TAC's history because it provides important context for why the right to

issue compulsory licenses, and the political resistance to that right, matters as much as it does.

29
3.​ Introduction to the Agenda Item: Regulating Pharmaceutical Lobbying and

Influence in Global Health Decision-Making

3.1.​ Definition and scope of pharmaceutical lobbying

Drug makers and their trade groups work hard to shape choices made by governments,

health regulators, and global bodies - aiming to protect their business goals. Though "lobbying"

began as talks held in hallways of legislative chambers, the term now covers far more than

face-to-face chats inside official spaces.

Lobbying shows up in ways people often recognize. Industry figures meet face to face

with public decision makers - sometimes at home, sometimes abroad. Papers handed in during

official rule-making windows count as one such method. So does speaking aloud when

lawmakers gather to question experts. Visibility comes from rules: some countries force these

actions into view by demanding records. Yet plenty stays hidden. Influence slips through quieter

doors. Money flows to labs inside colleges. This support steers what scientists choose to study. It

nudges which results make it into journals - or stay buried. Sponsorship of pro medical

gatherings helps them earn trust among doctors, slowly weaving ties that quietly shape health

debates behind the scenes. Funding groups that speak for patients gives their agenda a personal

touch - though those stances often line up more with profit than care.

Far from just knocking on doors in capital cities, big drug makers push their views

straight into global trade talks. Inside those rooms, decisions take shape about how tightly

medicine patents are guarded. The WTO's TRIPS deal plays a central role - it sets the timeline

for how long firms keep sole control over selling a new treatment, along with narrow paths

governments might follow to allow low-cost copies when public need demands it. Influence

30
seeps into WHO activities too, not always in obvious ways. Industry voices join expert panels,

file detailed comments during health guideline updates, build quiet but lasting ties with agency

staff who come and go slowly over time. Over months and years, these connections start shaping

which issues seem urgent, what kind of research feels most convincing, whose priorities quietly

rise above others when policies finally land on paper.

One difference stands out, noted by analysts who study power and rules. Real

involvement in shaping policy looks like sharing solid facts or hands-on knowledge within open

forums where many voices get space to speak. Not quite the same thing occurs when companies

quietly steer decisions behind closed doors. Influence turns into control when agencies start

acting less for citizens and more for the businesses they’re meant to oversee. Out in the open, it's

hard to tell where proper involvement ends and undue influence begins when it comes to global

health decisions. This gray area isn’t just background noise - it shapes why rules around drug

company lobbying resist easy fixes, since the issue runs deeper than catching clear wrongdoing.

3.2.​ Key actors and stakeholders in global health standarts

Not every player in global health holds the same power. Some bring money, others

influence, a few only voice. Each ties into the WHO in their own way - close partnerships,

distant nods, or barely linked at all. These links shift how decisions take form behind closed

doors. Names matter less than roles when tracing who sways policy. Pharmaceutical firms move

through this web like threads pulled tight. See where pressure builds, then follow the pattern

back. Who speaks loudest often depends on who funds what. A regulation talk without mapping

this tangle risks missing the real levers. Power hides in structure more than title. Talk of fairness

needs eyes open to that layout.

31
It’s governments who officially call the shots at the WHO, yet thinking of them as

speaking with one voice on drug rules misses reality. Not every part of a government agrees -

take how health departments see things differently from trade ones. Where doctors and public

health staff focus on keeping people safe, getting medicines to those in need, while measuring

overall community wellness. Meanwhile, trade teams watch out for business advantages local

drug makers might gain, pushing hard for tight patent controls. Drug firms know this split exists,

they do not ignore it. Instead, they build distinct ties across ministries, shifting effort toward

whichever office lines up best with what they want right now.

Not every drug company operates the same way. While some big firms pour money into

inventing brand-new treatments, they need patent shields to recoup expenses ahead of copycat

versions arriving. Once legal exclusivity ends, another set steps in - those making replicas sell at

lower prices, favoring faster approval routes. Their goals clash now and then, especially when

rules are debated. Groups such as IFPMA speak mostly for innovators, shaping unified messages

aimed at global bodies like the WHO. What one part pushes for, the other might quietly resist.

Nowhere has pressure come more steadily than from groups outside corporate halls -

groups such as Medecins Sans Frontieres, whose Access Campaign zeroes in on getting

medicines to those who need them. Instead of waiting, activists behind the Treatment Action

Campaign rose up during South Africa’s HIV/AIDS crisis, refusing silence. Meanwhile, across

borders, the People's Health Movement links voices from dozens of nations, building shared

demands. Because of their persistence, policy shifts did occuredn - not just talk. One turning

point arrived in 2001: the Doha Declaration on TRIPS and Public Health. There, governments

affirmed a clear power - to allow production or import of patented drugs without approval from

patent owners, if health emergencies call for it. That space to act didn’t appear by chance. It

32
emerged because campaigners held firm, joining forces with officials from poorer and mid-level

income countries who stood beside them.

Some studies come from university experts or small policy groups. These reports might

back up corporate statements - or question them sharply. It's not always clear when a study is

truly neutral versus shaped by funders behind closed doors. Money from charities also plays a

major role. The Bill and Melinda Gates Foundation sends vast sums to the World Health

Organization. That shapes which diseases get seen across nations. Attention follows cash, often.

When such donors pick winners, it raises concerns. Are their choices matching real public

demands? Ties between big philanthropy and drug makers - where assets overlap - add more

layers. Any serious talk about power in world health must include these threads. Hidden links

matter just as much as open ones

3.3.​ Why that issue is important for global health governance

Who makes the call at places like the WHO changes lives - plain and simple. Not

everyone gets medicine when choices favor profit over proof. What occurs next? Prices climb

beyond reach, especially where clinics run thin. Research skips deadly problems in struggling

nations just because cash flows elsewhere. Rules guard patents harder than they shield sick

people. Poorer regions feel this hardest - their hospitals strained, their wallets empty compared to

drug tags. Decisions far away shape survival close up.

A spotlight landed on global vaccine access when the coronavirus spread worldwide,

something earlier outbreaks never quite addressed. When lockdowns hit, nations with modest

resources pushed to pause parts of an international patent deal so local factories could make

shots even if inventors said no. Drug makers fought back fiercely - leaning on Washington and

33
Brussels - to stall talks then shrink what little compromise emerged. After slow debates stretched

on, the fix that passed barely effected anything on the ground. By then, delayed doses had cost

lives across continents where jabs arrived too late, giving the pathogen room to shift shape while

traveling unchecked.

Something deeper sits beneath the surface here, not just about single policies but how

things hold together. Trust keeps international health efforts alive. Countries listen to the WHO

when crises hit, build rules around its advice, shape buying choices based on its views - mainly

because they believe it acts for people’s health, not big business pockets. When closeness to drug

companies makes that belief waver, cooperation frays. The power to lead global actions fades,

regardless of official titles or papers signed long ago. Who sets the terms when drug makers meet

WHO officials? Rules here do more than block bad deals. They hold up the backbone of

worldwide health cooperation. Without them, the whole system risks bending or breaking.

3.4.​ The WHO’s role in holding the industry’s effect

Holding sway in global health isn’t easy when money talks louder than mandates.

Standards? The WHO can shape them - its voice carries weight in setting rules for pharma

conduct. Yet funds often arrive wrapped in strings, given through donors linked - closely or

loosely - to drug makers. Insider know-how on drugs flows where the industry allows; the

agency must rely on what it's fed. When conclusions inch too close to challenging profit lines,

pressure finds its way into rooms. Those with stakes react fast if policies tilt against their bottom

line. Authority means little without autonomy - and autonomy fades when support hinges on

silence.

34
Years went by before the World Health Organization began building ways to handle

clashes of interest in its technical projects. Participation in advisory panels means handing over a

statement about personal stakes first thing. Once submitted, team members at headquarters

examine each form carefully, judging if certain ties should block someone from joining particular

talks. When firms from outside step into view, a 2016 agreement sets boundaries - laying out

what occurs when business goals might Dönücem buraya decisions. On paper, it all seems

sensible enough. One morning in 2019, an inside check showed the approval system lacked

consistency - some reported ties slipped through without review or clear notes on next steps. It

turned out a few specialists involved in setting rules had money links to companies, yet those

connections weren’t shared early or examined at all.

When it comes to setting standards, the WHO has issued advice on handling bias in

medical recommendation writing. It joined global talks on drug price openness instead of staying

silent. Conversations around reshaping patent rules for greater health fairness have included its

voice too. These efforts hold no legal weight by themselves. What matters is if countries decide

to act on them - or ignore them. Companies play a role as well, depending on their willingness to

align. Real improvement in limiting pharma sway at the WHO won’t come just from tighter

internal procedures. Lasting change demands steady support from enough nations ready to

defend autonomy, even when pushing back angers influential local medicine makers. The size of

commitment shapes outcomes.

35
4.​ History and Past Events

4.1.​ Early Pharmaceutical Industry Involvement in Global Health Policy

Big medicine shaping world health rules didn’t start yesterday. Roots dig into the 1900s,

when drug firms began forming at the same time as global health bodies - later turning into what

supports today’s WHO. Germany, the U.S., and Britain held most of the major companies then.

When the WHO launched in 1948, those businesses already crossed national lines, linked to

government health departments everywhere. From the beginning, they saw how talks in faraway

meetings might shift their sales zones, reshape who owns inventions, or change how tightly

they’d be watched by regulators.

Out of nowhere, the release of the very first WHO Essential Medicines List back in 1977

put big pharma to an unexpected test. Suddenly, here was an organization stepping into territory

that brushed up against profit-driven choices. Instead of flashy names, the list pointed toward

basic treatments people truly required. Governments, particularly ones stretched thin financially,

could now lean on it to guide purchases wisely. It wasn’t about what just hit the market; it

focused on substances shown to work, without regard for price tags or brand labels. Yet, once

word spread, companies didn’t stay quiet for long. Out of sight but never far away, pressure

arrived via national channels - especially Washington - where drug makers plus trade groups

claimed the roster threatened invention rewards. That clash, noisy at the time, quietly shaped

how manufacturers now step into WHO decisions on medical supplies. You see traces today

whenever access fights heat up around treatments. The old pushback left fingerprints. Not rules,

just habits formed back when boundaries seemed clearer.

36
Starting back in 1981, the Action Programme on Essential Drugs began shifting how

medicine access was handled. Then came the 1988 Ethical Criteria for Medicinal Drug

Promotion - another step toward clearer standards. Instead of working hand in glove with drug

makers, these moves showed a pull away from corporate sway. Yet pushback followed quickly,

firm and unrelenting. Companies fought them. So did certain national authorities aligned with

those companies. Looking close at this past reveals something deeper than momentary clashes.

What we see isn’t new friction sparked lately between global health leaders and industry. These

strains trace all the way to the beginning. To grasp why they persist means peering into

long-term power patterns across international health institutions - not just reacting to what

occuredned last week.

4.2.​ Landmark Cases of Lobbying and Regulatory Capture

One clear example comes from history - how drug company influence shaped global

health rules. Early in the 1990s, talks began on what would become TRIPS, a worldwide deal

managed by the WTO. This agreement forced every member country to uphold strict patent laws,

especially for medications. Behind the scenes, a team made up of big U.S. firms like Pfizer,

Merck, and IBM helped write America’s stance during those trade discussions. Because of their

involvement, even poorer governments had to stop making low-cost versions of patented drugs.

What emerged was a system where medicine patents gained powerful new backing across

borders. Years passed before people saw how it affected communities, especially when treating

HIV and AIDS across sub-Saharan Africa - drug prices blocked access, locked behind patents.

Pressure built slowly, driven by protests, court battles, then talks among nations, until agreement

shifted in 2001 with the Doha Declaration.

37
What occuredned with baby formula back in the 70s and 80s wasn’t quite the same story,

yet it still shows how corporate influence works across borders. Firms like Nestle pushed their

powdered milk substitutes in poorer nations, running campaigns that made mothers doubt breast

milk - despite local conditions where safe mixing water often ran short. Because of this, more

babies fell sick, many died, sparking outcry from health advocates worldwide. After years of

debate, the World Health Organization moved to set rules limiting such marketing; however,

food and drug companies fought hard behind the scenes, trying to soften every rule proposed.

Only the United States opposed the measure when nations cast votes on the code during the 1981

World Health Assembly. Observers saw that moment clearly - industry pressure had shaped

Washington’s stance. This instance soon stood out in academic writings, a telling case of how

business interests could sway global health decisions.

Lately, doubts emerged about how the WHO handled its 2009 flu pandemic

announcement - answers weren’t easy to come by. When H1N1 was labeled a global threat,

nations moved fast, spending vast sums on drugs and shots. Turns out, some advisors guiding the

WHO had ties to drug firms cashing in on those very investments. The public didn’t know about

these links when decisions unfolded. Hidden connections surfaced only later through a European

parliamentary review. Even though the WHO dismissed claims painting the investigation in the

worst light, it admitted its methods for handling conflict-of-interest issues required major

changes. Public confidence in the agency’s separation from corporate pressures took a hit -

damage that stuck around.

38
4.3.​ Earlier WHO declarations and Reform Tries

Decades pass. One attempt after another, the WHO tries reshaping ties with drug makers.

This history matters less for answers it gives, more for the stubborn barriers always waiting in

the way. Back in 1986, the World Health Assembly backed a plan - new rules aimed at opening

up medicine promotion, pushing smarter prescribing habits worldwide. Right away, progress

stalls. Money never arrives. Execution leans on goodwill from countries and companies alike,

neither eager to shift course. Resistance quietly dooms effort before real change takes root.

Back in 2006, a group focused on intellectual property, innovation, and public health

dropped a thorough report that got plenty of Buray dönücem not1 Their look revealed a problem:

when firms depend on high prices during patent periods to earn back R&D spending, there’s

almost zero motive to make drugs for illnesses hitting poor nations hardest. Because here’s the

thing - those places can’t afford steep pricing, which kills any hope of solid profit. Since returns

fall short, effort drifts elsewhere. To fix this gap, the panel floated fresh ways to fund medical

breakthroughs without tying lab work expenses to what patients must shell out; meaning

treatment might reach more folks, regardless of wallet size. Many of these plans stalled along the

way. Pressure from industry groups played a big role - so did hesitation among wealthier

members unwilling to confront their own drug industries.

Back in 2008, countries agreed on a global plan about health, innovation, and patents

during a big meeting at the World Health Organization. Instead of bold moves, what followed ten

years later looked more like small gestures without real impact. Changes meant to shift how drug

research gets funded barely moved forward - held back or weakened beyond usefulness. Access

to medicine and pricing rules? Those tough topics got stuck too, diluted until they lost force.

39
Behind the scenes, powerful companies pushed against change while wealthy nations hesitated

or refused. That mix of corporate pressure and reluctance from rich governments turned out to be

the main roadblock. Ironically, that very obstacle was what the original plan hoped to overcome.

Again and again, big plans at the WHO have crashed into strong resistance, ending in small

changes only. To grasp today’s discussions, you need to see that old rhythm clearly.

5.​ Current Status

5.1.​ Usable Transparency Mechanisms and Limitations

One way some places track openness shows up in how money moves through health care.

Not every effort works perfectly. Each tries to cover something specific. Some fall short in daily

use. Across the U.S., a record called Open Payments started after a law passed in 2010. That rule

made companies share what they pay doctors and training hospitals - but only when amounts

pass a set level. What gets reported lands on the internet where anyone can dig into it. Reporters

might check one name. Scientists could study patterns. A person might search their own provider

just to see. Who gave funds, who got them - that part sits out in the open. Hidden connections in

money flows around medicine came to light because of this tool, yet gaps remain obvious. While

probes into how companies shape doctor habits have made use of it, coverage stops short in key

areas. Payments slip through when they go to civil servants or global agency workers instead.

Influence that comes through university grants often escapes notice too. So do quiet sponsorships

of health events or backing given to trade groups and activist [Link] ekleyeceğim

buraya

Over in Europe, drug makers follow rules set by their own group - the Federation of

Pharmaceutical Industries and Associations - which makes them share money flows to doctors

and medical groups. Trouble kicks in because those rules are policed internally, not handed off to

40
outside watchdogs. Without external checks, directness relies entirely on each company choosing

to come clean - no forced audits, no verification muscle behind it. On another track, the EU runs

its own openness system meant to map who lobbies lawmakers; since 2021, signing up became

required through a deal linking Parliament, Commission, and Council. Out in Brussels, drug

makers must list their lobbying efforts and spending. Yet experts say the official definition

misses key tactics scholars see as major leverage points. What counts under current rules leaves

too much influence off the books. Important moves occuredn beyond what gets reported. Some

actions shaping policy never show up in disclosures. The gap between rulebook terms and

real-world impact stays wide.

Right off the bat, WHO relies on disclosure forms to handle conflict-of-interest concerns.

Experts must fill out these documents before entering any technical meeting or advice session.

Instead of just showing up, they list business and money links tied to companies involved in

health matters. Staff at WHO get the job of going through each submission carefully. Depending

on what turns up, someone might be blocked from taking part if risks seem too high. Yet a look

inside from 2019 - done by watchdogs within the community itself - turned up uneven handling

across cases. Some records lacked follow-through, others missed notes entirely, while decisions

varied without clear patterns. Before any trial kicks off, registration on the WHO’s global

platform becomes mandatory. That small rule shifts how drug studies are seen - suddenly, hidden

outcomes are tougher to hide. Firms can’t simply spotlight favorable data while stashing

unfavorable ones away. Clearer records mean better information reaches decision makers. Still,

this fix covers just a fraction of deeper issues lurking behind medical research practices.

41
5.2.​ Regional Strategiesto Pharmaceutical Lobbying Regulation

Some places handle drug company lobbying in ways unlike others, shaped less by rules

alone and more by how much sway those businesses hold locally. Though law styles differ

globally, power dynamics often shape policy tighter than statutes do. In Europe, oversight goes

deeper than most regions dare attempt. Since 2021, an agreement binding across EU decision

hubs logs who tries to steer policy. Called the Interinstitutional Agreement on a Mandatory

Transparency Register, it pulls lobbyists into view - names, spending, tactics laid bare. Firms

hawking medicines near Brussels must sign up if they knock on legislators’ doors. Yet teeth

behind the system feel soft; penalties rarely bite. What counts as lobbying here misses subtler

moves firms make behind curtains. Still, compared to nearly everywhere else, this setup stands

out - not perfect, yet built with care.

Lobbying in the U.S. runs mostly under rules set by the federal Lobbying Disclosure Act.

Year after year, drug and health product companies stand near the top when it comes to how

much they spend trying to shape laws - often dropping more than three hundred million dollars

just at the national level. Yet what counts as lobbying according to that law leaves out many

tactics experts know matter deeply. Supporting university studies quietly? Not tracked. Backing

patient organizations financially? Left off authorized reports. Even slow-building personal ties

with people who work deep government health agencies slip past the radar. So do gatherings and

meetings arranged for doctors and clinic leaders. Because these actions don’t need disclosure, the

numbers we see only show part of the picture - the full cost of steering decisions stays hidden

beneath the surface.

42
Most places in sub-Saharan Africa, Latin America, and South Asia lack real rules on drug

company lobbying - even if some laws appear on paper, they rarely matter in daily work.

Because of this gap, medicine makers often talk to health departments, approval bodies, and

government doctors without having to share details or answer tough questions. Though the

African Union set up the African Medicines Agency to improve how drugs are managed across

nations, it still cannot act strongly; efforts to limit effect over health decisions remain weak

within its plans. With such big differences worldwide in how these interactions are handled, the

WHO faces deep trouble. Setting clear standards that fit neatly into 194 countries - each with

unique systems, politics, and ties to drug firms - turns progress into a slow, tangled path.

5.3.​ Ongoing Debates Within the WHO and Member States

Right now, talks inside the WHO and between countries swirl around drug company

power in world health decisions. To shape smart, believable policies, envoys need to grasp what's

being argued. These discussions matter more than they first appear.

One key question stands out above others. Is simply opening up information enough

when it comes to regulating how industries interact with the World Health Organization? Or

must there be stricter limits on their involvement altogether? Supporters of openness believe

clearer rules for declaring ties, tighter conflict-of-interest guidelines, plus listing every meeting

between corporate reps and WHO staff could balance risk while still allowing access to useful

knowledge from those firms. Others remain unconvinced by such measures. They point out that

revealing connections matters little if no consequences follow broken rules. The deeper issue lies

in unequal power. Private drug makers control budgets and teams so vast compared to advocates

for public welfare that light-touch reforms barely shift the scales. Even full visibility won’t

43
change outcomes when one side drowns out the rest through sheer scale. Influence flows where

resources gather, regardless of disclosed links.

One key issue now under discussion is how the WHO gets its money. Not much freedom

exists when most funds arrive with strings attached. Around eight out of every ten dollars given

to the agency do not go where it decides alone. Donors often decide what projects their payments

support, so health goals shift based on who pays, not global votes. Decisions made in Geneva

reflect donor demands more than shared agreements among countries. A growing number want

mandatory fees paid by all nations to rise sharply. These fixed charges could balance power and

widen real choice inside the agency. Richer governments tend to oppose such changes. Paying

larger shares scares some budgets. Others simply like having leverage over programs through

special donations. More independence might mean less control for those now calling the shots.

Right now, talks over the Pandemic Accord keep stirring strong reactions. These

discussions started back in 2021 and have quickly become the main political battleground when

it comes to how private firms shape global health rules. At their core, they're meant to create a

fresh worldwide deal focused on stopping pandemics before they start, getting nations ready,

then responding fast if outbreaks occur. One major point causing friction? Whether drugmakers

must hand over know-how or allow forced licenses - where governments let others produce

protected medicines - in times of crisis. Since the beginning, big pharma has stayed deeply

involved. Instead of speaking up directly, they usually push their views by influencing wealthy

countries’ positions, especially to block anything threatening patents or demanding secrets

behind how products are made.

44
5.4.​ Current Arguments and High-Statue Cases

Talk around drug company influence rules splits mostly two ways, even if real talk digs

deeper. Revenue from protected patents keeps medicine creation alive, backers claim. That

money covers heavy early costs tied to making treatments, they note. Missing it might slow

down new cures reaching people. Health groups like the WHO gain useful know-how when

firms join policy talks, another point raised. Shutting them out could weaken how solid decisions

become. Yet opponents push back hard. Economic logic aside, such points often block openness

efforts that wouldn’t hurt invention drive, critics observe. Past actions show repeated pushes

aimed at profits, not better health choices worldwide, they add.

Talk about hepatitis C medicine often pops up in debates on health policy, showing how

serious these issues really are. A company named Gilead Sciences in the United States created

sofosbuvir, a powerful pill that beats hepatitis C fast and works well. Making each round of

treatment costs just a small amount - only a few dollars. Yet Gilead charged huge sums for it

where people earn more money. In nations with lower incomes, officials tried using global trade

rules to let local makers produce cheaper versions legally - a move allowed under compulsory

licensing. Pressure followed. Through U.S. diplomatic routes and economic tools, Gilead pushed

hard to block those efforts. Though rarely acknowledged, Access groups laid out the lobbying

tactics plainly. This instance now surfaces often when people question whether today’s

international systems can truly check how drug makers leverage their influence, especially when

it limits medicine availability.

The COVID-19 vaccine equity situation generated a related and even larger-scale set of

arguments. Research by organizations including Oxfam and MSF documented that public

45
funding from governments in the United States, the United Kingdom, Germany and other

countries had contributed very substantially to the development of several leading COVID-19

vaccines, yet the benefits of that public investment were distributed in ways that strongly favored

wealthier countries that had the purchasing power to secure advance supply agreements. The

argument that public investment in pharmaceutical research and development should come with

public access conditions, meaning that medicines developed partly with public money should be

available on affordable terms to all populations, gained significant political momentum during

the pandemic. That argument is now explicitly part of multiple ongoing WHO negotiations and

is shaping debates about what any future Pandemic Accord should require.

5.5.​ Measurement Indicators and Cooperative NGO’S

Measuring how much pharmaceutical lobbying actually occurs in global health

governance, and what effect it has, requires analytical tools that go well beyond simply recording

how many times an industry representative has met with a government official. Several

organizations have developed frameworks and indicators that try to capture a more

comprehensive picture, and their work provides important empirical grounding for the policy

debates this committee will be conducting.

The Access to Medicine Foundation, a non-profit organization based in the Netherlands,

publishes an index every two years that ranks the world's largest pharmaceutical companies on

their policies and practices related to medicine access in low and middle-income countries. The

index uses a standardized methodology to assess companies on areas including how they price

products in poorer markets, what intellectual property policies they apply, how transparent they

are about their research and development activities and what access programs they maintain.

Because the index uses consistent methodology over time and covers the same companies across

46
consecutive editions, it allows investors, policymakers and advocates to track whether individual

companies are improving or deteriorating on access-related commitments. It also provides a

comparative framework that makes it harder for companies to claim progress in isolation without

that claim being checked against what their peers are doing.

Corporate Accountability and its partner organizations have built monitoring frameworks

specifically focused on documenting how the pharmaceutical industry engages with the WHO as

an institution. Their work involves tracking which industry representatives participate in which

WHO processes, mapping the networks of trade associations, front groups and allied

organizations through which industry preferences are channeled into policymaking discussions

and analyzing whether the outcomes of those discussions align with public health evidence or

with commercial interests. Transparency International's health integrity program produces

country-level assessments of corruption risks and undue influence in pharmaceutical systems,

identifying structural patterns in how industry actors exploit weaknesses in domestic regulatory

frameworks rather than focusing exclusively on individual misconduct incidents.

Among the non-governmental organizations most actively engaged in WHO policy

spaces, MSF's Access Campaign is consistently one of the most visible and technically capable

voices pushing back against industry-friendly positions in international negotiations. The Third

World Network, based in Malaysia, provides detailed technical analysis and direct support to

delegations from low and middle-income countries participating in WHO processes, helping to

partially compensate for the large resource gap between those delegations and the well-staffed

national missions and industry representatives from wealthier countries. The People's Health

Movement coordinates civil society actors from many countries around a shared framework

centered on health as a public good rather than a market commodity and has produced some of

47
the most thorough analytical work available on how corporate influence operates within WHO

governance structures. A growing body of expert opinion holds that strengthening the formal

recognition and practical capacity of these civil society actors within WHO processes is itself a

necessary component of any realistic strategy for managing pharmaceutical industry influence in

global health decision-making, because independent civil society monitoring provides a form of

accountability that does not depend on industry cooperation or on the willingness of powerful

governments to enforce rules against their own commercial interests.

6.​ Country Stances

United States of America

The United States is currently the most consequential and also the most disruptive actor

in global health governance. On January 20, 2025, President Trump signed an executive order

formally initiating withdrawal from the WHO, and the process was completed on January 22,

2026. All US government funding to the organization has been terminated, US personnel

embedded in WHO offices worldwide have been recalled, and participation in WHO-sponsored

committees and technical working groups has ceased. This withdrawal has removed the

organization's single largest donor and created a significant funding gap that other member states

are only partially filling. At the domestic level, the Trump administration has pursued a Most

Favored Nation pricing policy for pharmaceuticals, requiring that drug companies sell products

in the United States at prices no higher than the lowest price they charge in other developed

countries. This has created an unusual situation in which the US government is simultaneously

the most powerful historical defender of strong pharmaceutical patent rights in international

forums and an aggressive domestic critic of pharmaceutical pricing. The pharmaceutical lobby in

48
the United States spent over 334 million dollars on federal lobbying in the first three quarters of

2025 alone, a thirteen percent increase over the same period in 2024, demonstrating the intensity

of industry efforts to shape the current policy environment. For this committee, the US

withdrawal from the WHO is directly relevant because it removes a country that has historically

exercised enormous influence over WHO agenda-setting, and it opens political space for other

member states to advance reforms that the US previously blocked, including stronger

transparency measures and more flexible intellectual property frameworks for health

emergencies.

Russian Federation

Russia's approach to global health and pharmaceutical policy has shifted significantly

since the war in Ukraine began in 2022 and Western sanctions reshaped the country's relationship

with international markets. Domestically, the Russian pharmaceutical sector now operates under

a model of state-managed import substitution, meaning the government actively supports and in

some cases mandates the replacement of foreign medicines with domestically produced

alternatives. A high-profile example came when Novo Nordisk suspended supplies of

semaglutide, the active ingredient in diabetes and obesity treatments, to Russia in 2023. The

Russian government responded by issuing compulsory licenses to two domestic companies,

Geropharm and Promomed, to produce local generic versions. The Russian Supreme Court

upheld this action in 2025, applying the country's extreme necessity provisions under domestic

patent law. In terms of global health diplomacy, Russia has reoriented its engagement toward low

and middle-income countries, particularly those in Africa, Latin America and parts of Asia that

have historical ties to Moscow. The Russian Ministry of Industry and Trade subsidizes

pharmaceutical companies not subject to Western sanctions to expand into these markets, and

49
Russia promotes technology transfer to countries with political proximity as a tool of health

diplomacy. Russia remains a WHO member and participates in WHO processes, but its

engagement is increasingly shaped by geopolitical competition with Western states rather than by

shared global health governance objectives. On the question of pharmaceutical lobbying

regulation, Russia's state-centered model makes it relatively skeptical of frameworks that would

constrain government flexibility to use compulsory licensing or other tools to override

commercial patent rights.

People's Republic of China

China has dramatically increased its pharmaceutical policy activity at both the domestic

and international levels. In January 2025, the State Council published a comprehensive reform

guideline setting out twenty-four measures to position China as a global pharmaceutical leader,

covering faster regulatory approval processes, stronger intellectual property protections for

domestic innovators, anti-corruption compliance in pharmaceutical sales and expanded

international collaboration. China's National Medical Products Administration approved a record

eighty-four new pharmaceutical products in 2024, a twelve percent increase from the previous

year, and the country now represents close to one-third of all clinical-stage pharmaceutical assets

worldwide, placing it second only to the United States. Internationally, China has stepped in to

partially fill the WHO funding gap created by the US withdrawal, committing five hundred

million dollars to the organization after the US terminated its contributions. China's position in

WHO processes on pharmaceutical lobbying regulation is complex. On one hand, China has

implemented meaningful domestic anti-corruption measures in its pharmaceutical sector,

including a 2024 enforcement case against Hansoh Pharma for widespread bribery and the

issuance of anti-monopoly guidelines for pharmaceuticals in January 2025. On the other hand,

50
China's growing pharmaceutical export ambitions and its desire to protect its emerging

innovative drug sector mean it is unlikely to support international frameworks that would

significantly constrain patent rights or expose pricing practices to mandatory transparency

requirements. Delegates should expect China to position itself as a constructive global health

partner while protecting the commercial interests of its expanding domestic pharmaceutical

industry.

United Kingdom

The United Kingdom left the European Union in 2020 and has since developed an

independent pharmaceutical regulatory framework under the Medicines and Healthcare Products

Regulatory Agency, which was designated a WHO-Listed Authority in August 2025, meaning it

meets the highest international standards for regulatory oversight. The UK is also a member of

the Access Consortium, a grouping that includes Health Canada, the Australian Therapeutic

Goods Administration, Swissmedic and Singapore's Health Sciences Authority, which

collaborates on streamlined regulatory assessments to improve patient access to medicines across

all five jurisdictions. In December 2025, the UK reached a pharmaceutical pricing agreement

with the Trump administration as part of the broader US-UK Economic Prosperity Deal, under

which UK drug prices for new prescription medicines will increase by twenty-five percent. In

exchange, the US agreed to exempt UK-based pharmaceutical products from potential Section

232 tariffs. This deal has generated criticism from health campaigners who argue it prioritizes

market access over patient affordability. The UK remains an active participant in WHO

processes and has generally supported transparency measures in pharmaceutical governance,

though its willingness to push aggressively for stronger WHO-level pharmaceutical lobbying

regulation has been tempered by its own substantial pharmaceutical industry.

51
France

France is an active participant in the European Union's ongoing overhaul of its

pharmaceutical legislation, which reached a provisional agreement between the EU Parliament

and Council in December 2025. France has generally supported moderate reductions in

regulatory exclusivity rights for originator pharmaceutical companies as part of the EU Pharma

Law Package, favoring a balance between maintaining incentives for innovation and improving

access to medicines across EU member states. France has a significant domestic pharmaceutical

sector but also a strong tradition of public health regulation and national medicine pricing

oversight through its Haute Autorité de Santé. At the WHO level, France participates actively in

European region processes and has supported WHO transparency initiatives including the 2019

World Health Assembly resolution on pharmaceutical pricing transparency. French delegates in

WHO forums tend to advocate for frameworks that allow member states to use available tools

such as price negotiations and health technology assessment while maintaining strong research

and development ecosystems.

Germany

Germany is home to several large pharmaceutical and chemical companies and its trade

and economic interests in the sector are substantial. The German government has been criticized

domestically for delays in implementing a federal transparency law that would allow public

tracking of pharmaceutical industry lobbying of government officials, and the country ranks near

the bottom in Europe for freedom of information in this area. A Lobby Register Act update was

passed in March 2024 but civil society organizations have noted it still lacks provisions for

tracking exactly how industry representatives influence specific legislative decisions. At the EU

52
level, Germany has participated in the pharmaceutical legislation negotiations and its

parliamentary rapporteur Tiemo Wölken has been involved in the process throughout the trilogue

negotiations that concluded in December 2025. Germany's WHO engagement on pharmaceutical

lobbying regulation reflects the tension between its role as a major pharmaceutical producing

country and its broader commitment to multilateral health governance.

Japan

Japan has classified pharmaceuticals as specified essential goods under its Economic

Security Promotion Act, authorizing government subsidies for domestic production and reducing

reliance on foreign supply chains. Japan's Pharmaceuticals and Medical Devices Agency was

designated a WHO-Listed Authority in August 2025, and Health Japan collaborates closely with

the EMA, FDA and Health Canada on harmonized regulatory assessments. Japan increased its

development assistance for health by two percent in 2025, partly to help offset the WHO funding

gap created by the US withdrawal. Japan participated in the Pandemic Accord negotiations as a

vice-chair of the negotiating bureau and has generally supported frameworks for equitable access

to pandemic countermeasures while protecting the intellectual property interests of its domestic

pharmaceutical innovators.

Italy

Italy is a member of the European Union and participated in the EU Pharma Law

Package negotiations that concluded with a provisional agreement in December 2025. Italy has a

significant domestic pharmaceutical manufacturing sector, particularly in generic drug

production, and its positions in WHO processes generally align with the broader EU approach of

balancing medicine access with innovation incentives. Italy supports WHO transparency

53
initiatives in principle and has implemented pharmaceutical pricing transparency measures at the

national level through its regulatory agency AIFA.

Republic of Korea

South Korea passed its 2025 Synthetic Biology Promotion Act aimed at expanding

domestic biotech infrastructure and research and development capacity, consistent with a

regional trend of treating pharmaceutical production as a national security priority. South Korea

increased its development assistance for health by four percent in 2025, one of the few countries

to raise rather than reduce health aid contributions in a year when global health funding declined

significantly. South Korea is a member of the WHO International Drug Monitoring Programme

and participates actively in Asia-Pacific regulatory harmonization initiatives. Its positions on

pharmaceutical lobbying regulation at WHO generally align with those of other industrialized

democracies that support transparency without seeking fundamental changes to patent

frameworks.

Türkiye

Türkiye has been a member of the WHO International Drug Monitoring Programme since

1987 and participates in WHO European region processes. Turkey is identified alongside Brazil,

Russia, India, South Korea and others as one of the emerging pharmaceutical market countries

that together account for significant shares of global population and GDP. The country has a

growing domestic pharmaceutical manufacturing sector and has implemented national medicine

pricing controls. Turkey's WHO positions on pharmaceutical regulation tend to reflect its identity

as a middle-income country with both consumer and producer interests in the sector, generally

supporting affordable access measures while protecting its domestic industry.

54
Cuba

Cuba is facing a severe and ongoing pharmaceutical shortage that has reached crisis

levels. The Cuban Minister of Public Health acknowledged in July 2024 that medicine scarcity

would persist due to financial constraints and difficulties importing raw materials. The US

embargo, which has restricted Cuba's access to medicines and pharmaceutical inputs for decades,

is a central factor in this crisis, and Cuba consistently raises the embargo's health consequences

in international forums including the WHO. Despite its domestic shortage, Cuba has historically

developed several innovative pharmaceutical products through its state-owned biotechnology

sector, including treatments for cancer and hepatitis B, and has exported these to other

developing countries. Cuba's position in WHO processes on pharmaceutical lobbying is shaped

by its experience as a country whose access to medicines is directly constrained by the

commercial and geopolitical interests of powerful states and corporations, making it a consistent

advocate for stronger international frameworks that protect developing country rights against

pharmaceutical industry pressure.

Australia

Australia is a member of the Access Consortium, which coordinates regulatory work with

Canada, Singapore, Switzerland and the UK to streamline medicine approvals across the five

jurisdictions. The Therapeutic Goods Administration collaborates with the EMA, FDA and other

authorities on joint manufacturing inspections. Australia increased its development assistance for

health by three percent in 2025, directing additional funding toward strategically important

countries in the Pacific and Southeast Asia. Australia generally supports WHO transparency

initiatives and participates actively in WHO processes, though its positions are shaped by its

55
relationships with both the United States and with countries in its regional neighborhood where

medicine access is a pressing issue.

Denmark

Denmark is an active participant in Nordic pharmaceutical policy collaboration, including

joint procurement initiatives conducted through the Nordic Pharmaceutical Forum with Norway

and Iceland. The Danish hospital procurement agency AMGROS has developed environmental

award criteria for pharmaceutical tenders and piloted them in joint Nordic procurement rounds.

Denmark participates in the WHO European Region's Access to Novel Medicines Platform,

which established a working group on pharmaceutical pricing transparency in January 2024.

Denmark generally supports strong transparency requirements for the pharmaceutical industry

and has been engaged in WHO discussions on implementing the 2019 World Health Assembly

resolution on pricing transparency.

Canada

Health Canada was designated a WHO-Listed Authority in August 2025, recognizing that

it meets international regulatory standards for medicine oversight. Canada is a member of the

Access Consortium and collaborates with the EMA, FDA and other authorities on regulatory

harmonization. Canada participates in WHO processes and generally supports pharmaceutical

transparency measures, though its domestic pharmaceutical policy has long involved

negotiations between government and industry on pricing through the Patented Medicine Prices

Review Board.

56
Brazil

Brazil is one of the key emerging pharmaceutical market countries alongside Russia,

India, China and South Africa, accounting for a significant share of the global pharmaceutical

market. Brazil has historically been an important voice in WHO debates on access to medicines

and intellectual property, and the country exercised compulsory licensing for HIV medicines in

2007 in a case that set an important precedent. Brazil participated in the Pandemic Accord

negotiations as a vice-chair of the negotiating bureau. Brazil generally advocates in WHO

forums for policies that protect developing country rights to access affordable medicines and that

place equitable access alongside innovation incentives in pharmaceutical governance

frameworks.

United Arab Emirates

The UAE has a rapidly growing pharmaceutical market, supported by expanding

government health expenditure and compulsory health insurance programs introduced since

2012. The UAE has been a member of the WHO International Drug Monitoring Programme

since 2013 and participates in WHO processes. The country's pharmaceutical policy focus is

primarily on building domestic manufacturing capacity, improving regulatory standards and

ensuring medicine supply security for its population, rather than on the governance reform

questions that are central to this committee's agenda.

Spain

Spain is an EU member state and participated in the pharmaceutical legislation

negotiations, with Dolors Montserrat serving as the European Parliament rapporteur for the

57
proposed directive in its final stages. Spain generally aligns with the EU position on

pharmaceutical regulation, supporting the balance between access and innovation that

characterized the December 2025 provisional agreement. Spain is also a member of the WHO

International Drug Monitoring Programme since 1984 and participates in European region WHO

processes.

Poland

Poland held the rotating EU Council presidency during the period when the Council

adopted its negotiating position on the EU Pharma Law Package in June 2025, giving it an

important coordinating role in those negotiations. Poland is a member of the WHO International

Drug Monitoring Programme since 1972 and participates in WHO European region processes,

generally aligning with EU positions on pharmaceutical governance questions.

Luxembourg

Luxembourg is a small EU member state with a significant financial and administrative

presence in the pharmaceutical sector due to the location of several European pharmaceutical

industry headquarters and regulatory bodies in its territory. Luxembourg participates in EU

pharmaceutical governance discussions and in WHO European region processes, generally

aligned with the broader EU position.

Netherlands

The Netherlands is home to several organizations that play important roles in global

pharmaceutical accountability, including Health Action International and the Access to Medicine

Foundation, both of which are referenced elsewhere in this study guide. The Netherlands has

58
been active on pharmaceutical pricing transparency and the Dutch Pharmaceutical

Accountability Foundation, established in 2018, has pursued legal action against companies

charging excessive prices for medicines in the Dutch market. In July 2025, the Amsterdam

District Court issued a judgment in a case brought by the Dutch Pharmaceutical Accountability

Foundation. The Netherlands participated in the development of the WHO European Region's

Access to Novel Medicines Platform transparency working group and generally supports

stronger transparency requirements for pharmaceutical pricing and industry engagement with

health governance institutions.

Sweden

Sweden participates in Nordic pharmaceutical collaboration including joint procurement

through the Nordic Pharmaceutical Forum and has experience applying environmental criteria in

pharmaceutical tenders. Sweden is a long-standing member of the WHO International Drug

Monitoring Programme since 1968 and participates actively in WHO European region processes,

generally supporting transparency and access measures.

Switzerland

Switzerland is home to several of the world's largest pharmaceutical companies including

Roche and Novartis, giving it significant commercial interests in maintaining strong intellectual

property protections in international pharmaceutical governance. Swissmedic, the Swiss

medicines regulatory authority, is a member of the Access Consortium and collaborates with

other leading regulatory agencies on harmonized assessments. Switzerland and Liechtenstein

were jointly referenced in the US MFN executive order as parties to existing pharmaceutical

trade commitments with the United States. Switzerland participates in WHO processes as a host

59
country to WHO headquarters in Geneva and generally advocates for frameworks that balance

innovation incentives with access objectives.

Norway

Norway participates in Nordic pharmaceutical collaboration and the WHO European

Region's Access to Novel Medicines Platform. Norway has been active in discussions about

pharmaceutical pricing transparency and medicine procurement. As a non-EU member of the

European Economic Area, Norway participates in many EU pharmaceutical governance

discussions and generally aligns with Nordic and European positions on transparency and access

measures.

Finland

Finland participates in Nordic pharmaceutical cooperation including joint procurement

initiatives and the Nordic Pharmaceutical Forum. Finland is a member of the WHO International

Drug Monitoring Programme and participates in WHO European region processes, broadly

aligned with the Nordic and EU approach to pharmaceutical governance.

Ukraine

Ukraine is a WHO member state participating in the WHO International Drug Monitoring

Programme since 2002. The ongoing war has severely disrupted Ukraine's pharmaceutical

supply chains and health system, making access to medicines a critical and immediate national

priority. Ukraine's engagement in WHO pharmaceutical governance debates is shaped primarily

by the urgent practical need to maintain medicine supply for its population under wartime

conditions.

60
Singapore

Singapore is a member of the Access Consortium, which coordinates pharmaceutical

regulatory work with Australia, Canada, Switzerland and the UK, and the country's Health

Sciences Authority participates in joint regulatory assessments across the group. Singapore has a

well-developed pharmaceutical regulatory framework and participates in Asia-Pacific regulatory

harmonization initiatives. Singapore's WHO positions on pharmaceutical governance tend to

reflect its status as an advanced economy with strong regulatory capacity and an interest in

maintaining streamlined international regulatory pathways.

Portugal

Portugal is an EU member state participating in the pharmaceutical legislation

negotiations and in WHO European region processes, generally aligned with EU positions on

pharmaceutical governance. Portugal has been a member of the WHO International Drug

Monitoring Programme since 1993.

Liechtenstein

Liechtenstein is a small European state that participates in EU pharmaceutical

governance frameworks as part of the European Economic Area and was specifically referenced

alongside Switzerland in the US MFN executive order on pharmaceutical trade commitments.

Liechtenstein participates in the European pharmaceutical regulatory framework and aligns

broadly with Swiss and EEA positions on pharmaceutical governance questions.

Belgium

61
Belgium hosts the headquarters of the European Federation of Pharmaceutical Industries

and Associations in Brussels and is therefore central to European-level pharmaceutical industry

lobbying activities. Belgium is an EU member state and participates in the EU pharmaceutical

legislation process. Belgium has been a member of the WHO International Drug Monitoring

Programme since 1968 and participates in WHO European region processes.

Myanmar

Myanmar is a recent addition to the WHO International Drug Monitoring Programme,

with membership recorded from 2026. The country's pharmaceutical regulatory capacity is

limited, and access to essential medicines remains a significant challenge, particularly in rural

areas and in conflict-affected regions. Myanmar's engagement with WHO pharmaceutical

governance debates is shaped primarily by its need for regulatory support and medicine access

rather than by positions on lobbying regulation frameworks.

Guinea

Guinea is part of the Economic Community of West African States and participates in

West African pharmaceutical regulatory harmonization efforts under the framework of the

African Medicines Regulatory Harmonization initiative. Guinea has ratified the African

Medicines Agency treaty, which commits the country to a broader African regulatory framework.

Medicine access and regulatory capacity building are the primary pharmaceutical governance

concerns for Guinea rather than lobbying regulation at the international level.

62
Turkmenistan

Turkmenistan is a WHO member state and participates in WHO processes. The country's

pharmaceutical sector is heavily state-controlled and access to medicines is managed through

government procurement. Turkmenistan's engagement in international pharmaceutical

governance debates is limited, and its positions are shaped primarily by domestic health system

needs.

Congo

The Republic of Congo participated in a WHO assessment of pharmaceutical regulatory

gaps across Central and West Africa, which found significant shortfalls in regulatory capacity

and medicine quality monitoring. Congo's pharmaceutical regulatory framework is still

developing and the country is focused primarily on building basic regulatory infrastructure and

improving access to quality medicines. International debates about lobbying regulation are

secondary to these foundational concerns.

Ghana

Ghana participates in West African pharmaceutical regulatory harmonization and is

among the African countries working to strengthen its national medicines regulatory authority.

Ghana is also affected by the regional opioid misuse crisis involving pharmaceutical tramadol,

with high rates of misuse documented in 2024. Ghana's positions in WHO forums focus

primarily on medicine access, quality assurance and regulatory capacity rather than on lobbying

regulation frameworks.

63
Tonga

Tonga is a small Pacific island state with limited pharmaceutical regulatory infrastructure

and significant dependence on imported medicines. Australia's development assistance for health

in the Pacific, including in countries like Tonga, is relevant context for understanding how

smaller island states access medicines. Tonga's engagement in WHO pharmaceutical governance

processes is limited, and its primary concerns center on ensuring affordable and reliable access to

essential medicines for its small population.

Togo

Togo participates in West African pharmaceutical regulatory harmonization through

ECOWAS frameworks and has had a national medicines policy in place, though implementation

has faced challenges. Togo has been a member of the WHO International Drug Monitoring

Programme since 2007. Like most low-income West African states, Togo's WHO engagement on

pharmaceutical issues centers on access, quality and regulatory support rather than on

international lobbying regulation debates.

Oman

Oman has been a member of the WHO International Drug Monitoring Programme since

1995 and has a functional pharmaceutical regulatory system. The country participates in WHO

processes and its pharmaceutical policy focus centers on ensuring medicine supply security and

improving regulatory standards within the Gulf region context.

Guyana

64
Guyana is a South American state participating in WHO processes as a member of the

Americas region. The country's rapidly growing economy following major oil discoveries has

increased government capacity for health investment, and medicine access improvements are

among the health system priorities. Guyana participates in WHO discussions primarily as a

developing country with an interest in affordable medicine access frameworks.

Morocco

Morocco established a new Moroccan Agency for Medicines and Health Products, known

by its French acronym AMMPS, in 2023 as part of a broader reform of its pharmaceutical

regulatory governance. This reform reflects a push toward modernizing regulatory oversight and

improving both medicine access and quality standards. Morocco participates in African

pharmaceutical regulatory harmonization discussions and in WHO processes, positioning itself

as a country building toward stronger pharmaceutical governance capacity on the African

continent.

Gabon

Gabon has ratified the African Medicines Agency treaty, committing to the continental

pharmaceutical regulatory harmonization framework promoted by the African Union. Gabon

participated in the WHO assessment of pharmaceutical regulatory gaps in Central Africa. Its

WHO engagement on pharmaceutical issues centers on regulatory capacity building and

medicine access rather than on international pharmaceutical lobbying regulation debates.

65
7.​ Questions to be Addressed

●​ What binding standards should the WHO establish to require member states to disclose

pharmaceutical industry interactions with national health policymakers?

●​ To what extent should the WHO restrict pharmaceutical industry participation in

technical consultations and guideline development processes where conflicts of interest

cannot be adequately managed?

●​ How should the WHO reform its funding model to reduce dependence on earmarked

voluntary contributions and protect its agenda from donor influence?

●​ What measures should member states adopt to close the resource gap between

pharmaceutical industry actors and civil society organizations in WHO policymaking

processes?

●​ How should the Pandemic Accord balance pharmaceutical companies' intellectual

property rights with equitable access to medical countermeasures during health

emergencies?

●​ What role should the WHO play in ensuring that trade negotiations involving

pharmaceutical patents adequately reflect public health considerations?

●​ How can the WHO develop independently enforced pharmaceutical pricing transparency

standards that apply consistently across member states with different regulatory

capacities?

8.​ References

66
A.O. Shearman. (2025, September 16). Drug and medical device regulation under the

Trump administration.

[Link]

-device-regulation-under-the-trump-administration

Adibe, M. O., Ayuba, M. A., & Ukwe, C. V. (2019). Drug manufacturing and access to

medicines: The West African story. AAPS Open, 5(1), Article 12.

[Link]

Borges, L. C., Zeferino de Menezes, H., & Crosbie, E. (2025). Power, disputes, and

geopolitics in the pharmaceutical sector. ResearchGate.

[Link]

Pharmaceutical_Sector

Carnegie, T. C. (2025, November 13). Pharmaceutical policy in motion: Updates on the

Trump administration's drug pricing initiatives. Mintz.

[Link]

on-updates-trump

Carnegie, T. C. (2025, December 23). Pharmaceutical policy in motion continued: Trump

inks nine new drug pricing deals. Mintz.

[Link]

on-continued-trump-inks-nine

DDReg Pharma. (2025, September 10). China's healthcare and life sciences regulatory

evolution in 2025.

67
[Link]

on-in-2025/

Dieleman, J. (2025, August). The state of global health funding: August 2025. Think

Global Health.

[Link]

DrugPatentWatch. (2026, January 20). The Russian pharmaceutical industry: A definitive

guide to strategic evolution, geopolitical realities, and market sovereignty.

[Link]

key-players-and-technological-innovation/

DSM-Firmenich Health, Nutrition & Care. (2025, August 20). Ask the expert: What's

next for pharma regulations in Asia-Pacific?

[Link]

[Link]

European Commission. (2025, July 10). COM(2025) 392 final: Communication from the

Commission to the European Parliament and the Council.

[Link]

ename=international_com2025-392_act_en.pdf

European Medicines Agency. (2025). Regulatory cooperation to improve global health.

EMA Annual Report 2024.

[Link]

lth/

68
European Parliament. (2025). Revision of the EU pharmaceutical legislation. Legislative

Train Schedule.

[Link]

maceutical-legislation

Greenberg Traurig. (2025, July 11). China on the move: China's healthcare and life

sciences regulatory evolution in 2025.

[Link]

s-regulatory-evolution-in-2025

Health Policy Watch. (2025, December 28). 2025: A brutal year for global health.

[Link]

Hogan Lovells. (2025). EU pharma law package: Council position on reduction of

regulatory exclusivity rights.

[Link]

ction-of-regulatory-exclusivity-rights-

Lexology. (2025, January 21). Life sciences law update: Key developments for pharma

and medical device companies in EU and Germany, France, UK, Italy and Spain in Q4/2024.

[Link]

Medicines Law & Policy. (2025, December). Wrapping up 2025: A tumultuous year for

global public health law & policy.

[Link]

lic-health-law-policy/

69
Ndombi, E. M., Ngouille, J., & Lamy, M. (2024). Identifying and costing common gaps

in Central and West Africa pharmaceutical regulation. Frontiers in Medicine, 11, Article

1362253. [Link]

Ogalo, H. A., Muyembe, J. J., & Mhuriro-Masheke, T. (2025). Revisiting the issue of

access to medicines in Africa: Challenges and recommendations. PMC.

[Link]

OpenSecrets. (2025, October 8). Trump moves against direct-to-consumer drug ads

despite massive lobbying by pharmaceutical industry.

[Link]

espite-massive-lobbying-by-pharmaceutical-industry/

Pacific Bridge Medical. (2025). China pharma regulation update 2024–2025.

[Link]

e-key-developments-in-2024-2025/

Perehudoff, K., & colleagues. (2025). Pharmaceutical transparency: From resolution to

reality. Wemos & Health Action International.

[Link]

[Link]

Schiavetti, B., Landa, K., Toumi, M., & Evetovits, T. (2024). Abstracts from the 5th PPRI

conference 2024: Ensuring access to affordable medicines through innovative policies, Vienna,

Austria, 25–26 April 2024. Journal of Pharmaceutical Policy and Practice, 17(1).

[Link]

70
Sinolytics. (2026, January 29). How pharmaceuticals became geopolitical in 2026.

[Link]

State Council of the People's Republic of China. (2025, January 3). China deepens

comprehensive reform to strengthen drug, medical device regulation.

[Link]

[Link]

Think Global Health. (n.d.). A new era for Russian foreign policy on global health.

[Link]

The White House. (2025, May 12). Delivering most-favored-nation prescription drug

pricing to American patients [Presidential action].

[Link]

ption-drug-pricing-to-american-patients/

The White House. (2026, April 3). Adjusting imports of pharmaceuticals and

pharmaceutical ingredients into the United States [Presidential action].

[Link]

and-pharmaceutical-ingredients-into-the-united-states/

U.S. Department of Health and Human Services. (2026, January 22). HHS fact sheet:

U.S. withdrawal from the World Health Organization. Centers for Disease Control and

Prevention. [Link]

Wilson, M. R. (2025, October 21). Drug companies dominate lobbying as Trump

demands pricing cuts. The Washington Post.

71
[Link]

-prices/

Wikipedia. (2026). Moroccan Agency for Medicines and Health Products.

[Link]

World Health Organization. (n.d.). Access to medicines project wraps up amid progress

and hope.

[Link]

d-progress-and-hope

World Health Organization. (n.d.). Programme for International Drug Monitoring.

[Link]

networks/pidm

World Health Organization. (2025, August 7). WHO designates new WHO-listed

authorities, strengthening global access to quality-assured medical products.

[Link]

hening-global-access-to-quality-assured-medical-products

World Health Organization Regional Office for Africa. (2025, July 25).

AFR/RC75/[Link]/8: Progress report on the regional strategy for medical products.

[Link]

eport%20Regional%20Strategy%20of%20Medical%[Link]

World Health Organization Regional Office for Europe. (2024, January 3).

WHO/Europe's Novel Medicines Platform launches working group on transparency to improve

72
access to medicines.

[Link]

nches-working-group-on-transparency-to-improve-access-to-medicines

World Health Organization Regional Office for Europe. (2024, July 1). WHO/Europe

meets with the European Federation of Pharmaceutical Industries and Associations.

[Link]

tion-of-pharmaceutical-industries-and-associations

World Health Organization Regional Office for Europe. (2025). Report of the

consensus-building meeting of the WHO Regional Office for Europe Access to Novel Medicines

Platform: Copenhagen, Denmark, 2–3 July 2024 (WHO/EURO/2025-11104-50876-77155).

[Link]

73

You might also like