Vietnamlawmagazine

Hai Quang Le, IP Consultant

Jürgen W. Simon, Prof. Dr. mult. h.c., MBA

Linh Chi Dang - M.A. Candidate of Governance and Public Policy

Access to essential medicines in developing countries, including Vietnam, remains a critical challenge due to patent-related barriers. The COVID-19 pandemic underscored these difficulties, highlighting the urgent need for affordable medications. In response, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement provides certain flexibilities that allow developing countries to manufacture or import essential medicines at lower costs, particularly during public health emergencies. These flexibilities include compulsory licensing, which permits governments to authorize the production of patented medicines without the consent of the patent holder, and parallel imports, which enable countries to import patented drugs from nations where they are sold at lower prices.

Nevertheless, TRIPS flexibilities have significant limitations. Ambiguous legal provisions, national policy uncertainties, and political pressure from developed countries often restrict their effective implementation. As a result, TRIPS mechanisms alone are insufficient to ensure equitable access and availability to medicines, making alternative approaches necessary.

Therefore, this article examines two complementary strategies to address these challenges:

(i) Access insufficiency solutions, which focus on reducing costs and improving distribution to make existing medicines more affordable; and,

(ii) Availability insufficiency solutions, which aim to stimulate research and development (R&D) for neglected diseases that lack effective treatments.

Both approaches are essential, as ensuring affordability (access) is meaningless if the medicines for certain diseases do not exist (availability).

Attempts addressing access insufficiencies

Differential pricing

Differential pricing, which is based on the concept of price discrimination, is a strategy where firms charge different prices for the same product to different customers based on their willingness and ability to pay, rather than being based on different supply costs. This approach aims to improve access to essential medicines in developing countries by setting low prices in low-income or developing countries. The idea is to make medicines more affordable in low-income regions while still covering R&D costs through higher returns from developed markets.^[1] During the COVID-19 pandemic, this strategy was effectively used by vaccine manufacturers like Pfizer and AstraZeneca.^[2] They offered lower prices for vaccines in middle and low-income countries, ensuring broader access.^[3]

Differential pricing can be implemented in two ways, including:

* A fully market-based approach:  Under this approach, market segmentation is established, allowing the market to determine a global system of differential prices, as it is in the seller's best interest to do so.

However, this scenario is unlikely due to referential pricing pressures in wealthy nations. For example, if low-income prices reflect marginal production costs, developed countries could demand similar pricing, jeopardizing R&D returns.^[4] This creates a fundamental challenge: Balancing affordability for low-income consumers while maintaining high prices in high-income countries to offset fixed costs is extremely difficult.

* Bilateral price negotiation: In this method, price discounts are negotiated on a product-by-product and country-by-country basis between buyers and sellers. Also, when big organizations like the World Health Organization (WHO) buy in large amounts for many small countries, it can help get better deals. These contracts can include flexible rules to protect against selling the goods in more expensive markets.^[5] For instance, bulk purchasing agreements used during the COVID-19 pandemic have proved to secure affordable rates.

Nevertheless, to sustain such a pricing model, it is crucial to prevent the resale of low-priced medicines to high-priced markets. Market segmentation must be maintained, and reference pricing schemes in developed countries shouldn't be influenced by prices in developing countries. This approach ensures a balance between affordability and incentives for further R&D. 

In short, differential pricing can enhance access to medicines globally, provided market segmentation is securely managed. However, it struggles with maintaining market segmentation and preventing price leakage, which can undermine affordability and incentives for pharmaceutical companies.

Drug donations

When recipients cannot afford medicines, even at low prices, donations can improve access. Pharmaceutical companies engage in donation programs as part of their corporate social responsibility (CSR), which boosts their public image and provides tax benefits.^[1]

During the COVID-19 pandemic, drug donations significantly boosted vaccine access in developing countries. Key initiatives included bilateral donations and the COVAX Facility, co-led by Gavi, CEPI, and WHO. This effort enabled vaccine distribution to many developing and least-developed countries like Afghanistan, Bangladesh, Ethiopia, Kenya, Mozambique, Nepal, and Pakistan.^[2]

Despite these measures, the donations often fell short, leading to significant challenges in obtaining vaccines, treatments, and diagnostic tests in many low and middle-income countries.^[3] Furthermore, even with many helpful health initiatives through drug donations, there are still several obstacles. Donated drugs can still be too costly for developing countries due to the infrastructure needed for efficient distribution and effective use.^[4] Patent conditions may come with donations, such as TRIPS flexibilities.^[5] Donations are also often unsustainable, limited by time, amount, specific diseases, and countries, thus having limited effects.^[6] Additionally, drug importation regulations and custom duties can pose legal and costly challenges.^[7] Donations may also discourage local drug production in recipient countries.^[8]

In conclusion, while differential pricing and drug donations can improve access to essential medicines in developing countries, their effectiveness depends on managing market segmentation and preventing price leakage. Both strategies face challenges such as sustainability, infrastructure limitations, and legal obstacles that can hinder their long-term impact. Ultimately, a balance between affordability and incentivizing innovation is crucial for improving global access to healthcare.

Ceremony to receive 811,200 doses of COVID-19 vaccine at the National Vaccine Storage Facility in Hanoi

Attempts addressing availability insufficiencies

"Push" and "Pull" mechanisms

“Push” and “pull” mechanisms are designed to promote drug development by enhancing investment returns, guiding profit-oriented companies in their R&D fund allocation. Combining both mechanisms is the most effective. “Push” mechanisms subsidize basic scientific research, usually conducted at universities, reducing costs and risks for the private sector, which is responsible for turning basic research into usable products.^[9] “Pull” mechanisms offer rewards for developing specific desired products, creating markets and increasing profitability.^[10] They help public researchers and private developers focus on R&D for urgently needed Type II and III medicines.^[11]

"Push" of basic research

The initial phases of basic research and drug discovery are primarily conducted by public universities and research institutes, funded by governments. Discoveries are then developed further by pharmaceutical companies.^[12] Developed countries contribute 96 percent of the funding, with the US being the largest contributor. Over the past 40 years, universities have increasingly patented their discoveries,^[13] driven by the US Bayh-Dole Act of 1989. This has shifted the focus toward lucrative diseases rather than neglected ones.^[14] Despite this, publicly funded research has historically led to significant drug discoveries. The Commission on Health Research for Development recommended that governments allocate 2 percent of health budgets to essential research and that donor nations allocate 5 percent of aid to research and strengthening research capacity.^[15] These recommendations have been reiterated by various reports and the WHO World Health Assembly in 2005, but implementation has been limited.^[16] Philanthropic private non-profit sectors, including foundations and charities, play a significant role in funding R&D for neglected diseases, contributing 17% of the global R&D budget specifically for these diseases.^[17] Major contributors like the Bill & Melinda Gates Foundation and the Rockefeller Foundation have been crucial in linking public research and private development to create essential medicines for developing countries.^[18]

Publicly funded research has historically played a crucial role in medical advancements, but it faces several limitations. Despite significant government investments, the process of translating discoveries into widely available treatments remains slow and inefficient. Public research institutions primarily focus on early-stage discovery, while commercialization, large-scale production, and equitable distribution remain underdeveloped.[19] Moreover, patent and licensing complexities can create access barriers, as universities increasingly prioritize revenue generation through exclusive agreements with pharmaceutical companies.[20]

These structural limitations highlight the need for complementary strategies beyond basic research. While increased public investment in neglected diseases is essential, stronger mechanisms are needed to incentivize private-sector engagement, streamline the commercialization process, and ensure that publicly funded discoveries lead to affordable and accessible medicines. Without addressing these gaps, even groundbreaking research may fail to translate into real-world health benefits.

“Push” of research and development: public-private partnerships

Public Private Partnerships (PPPs) are collaborative efforts between different partners, often categorized as “push” mechanisms. They play a key role in disease-specific programs by leveraging each partner's unique resources and expertise, such as public funding, philanthropic donations, product development, manufacturing, marketing, research capacities, IPRs, data, equipment, and in-kind assets.

Three attributes define a Public Private Partnership:^[1]

●                 Involvement of at least one private for-profit organization and one not-for-profit organization, with potential for additional partners.

●                 Joint sharing of efforts and benefits, creating a win-win situation and motivating collaboration.

●                 Commitment to improving health for disadvantaged populations.

PPPs can be categorized into three types:^[2]

●                 Partnerships for improving access to pharmaceuticals through donations and distribution.

●                 Partnerships aimed at global coordination and financing mechanisms.

●                 Partnerships focused on product development (PDPPPs).

While the first of these categories was already discussed above in regard to donations (and cannot be categorized as “push” nor “pull” mechanism), in the following, the focus will be on the latter two.

Global coordination and financing

Public Private Partnerships often incorporate coordination and financing mechanisms. Some PPPs, such as the Stop Tuberculosis (TB) Partnership, the Roll Back Malaria Partnership (RBM), the Global Alliance for Vaccines and Immunization (GAVI), and the “3 by 5” Initiative, focus on global coordination for specific disease programs. These programs aim to strengthen health systems, ensure better healthcare delivery, prevent diseases, provide health education, train healthcare personnel, and encourage R&D for new medicines, vaccines, and diagnostics.^[1] Other PPPs, like the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and the Vaccine Fund, primarily provide funding for such programs, relying heavily on contributions from governments, international institutions, and philanthropic organizations.^[2] They all organize, coordinate, and finance programs as previously described, each with their particular focus. An exemplary overview of the form, objectives, and operations of the Stop TB Partnership (Stop TB PPP) will be provided below, given the diversity of such PPPs.

The Stop TB Partnership and Public-Private Partnership (PPP), initiated in 2000, is a global network uniting international organizations, governments, donors, and other entities to combat tuberculosis (TB).^[3] Its goals include diagnosing and treating TB cases, halving the TB disease burden (deaths and prevalence) by 2015 compared to 1990 levels, and eliminating TB as a public health threat by 2050. The partnership has formed working groups in seven areas: Directly Observed Treatment, Short-course (DOTS) Expansion, TB/HIV, Multidrug-Resistant TB (MDR-TB), New TB Drugs, New TB Vaccines, New TB Diagnostics, and Advocacy, Communications, and Social Mobilization. The specific complex objectives of these groups are:[4]

●                 Expanding access to diagnosis and treatment through DOTS,

●                 Improving the availability and quality of TB medicines,

●                 Adapting strategies to manage MDR-TB and HIV-associated TB,

●                 Supporting research for innovative TB drugs, diagnostics, and vaccines, and

●                 Ensuring proper implementation and accessibility of new tools.

Additionally, the working groups contribute to and fund various projects,[5] including extensive collaborations in research and development through the New TB Drugs group. This involves universities, pharmaceutical companies, and other stakeholders[6] focusing on discovery, clinical, and preclinical work.[7]

Partnerships focused on product development (PDPPPs)

Approximately 20 PDPPPs support basic research and clinical trials for specific diseases or specific disease areas, for example, International AIDS Vaccine Initiative (IAVI) for HIV/AIDS, Medicines for Malaria Venture (MMV) and Malaria Vaccine Initiative (MVI) for Malaria, Global Alliance for Tuberculosis Drug Development (TB Alliance) for Tuberculosis, and Drugs for Neglected Diseases initiative (DNDi) for neglected diseases.^[1]

PDPPPs use a portfolio approach to develop multiple candidate products, increasing success rates.^[2] By collaborating with various partners and relying on public and philanthropic funding, they aim to create products that are widely and affordably available. These partnerships set specific conditions for product distribution and pricing to ensure accessibility in target markets.^[3] Ultimately, PDPPPs support high-cost, high-risk projects while advancing basic research into marketable products.^[4]

During the COVID-19 pandemic, key “push” efforts for research and development included CEPI, which invested in a diverse portfolio of vaccine candidates to accelerate development.^[5] This strategy facilitates the concurrent advancement of numerous vaccine candidates, hence enhancing the likelihood of effective results. Operation Warp Speed (OWS), a U.S. government PPP, significantly sped up vaccine development, achieving viable vaccines in 12-18 months. The COVID-19 Therapeutics Accelerator (CTA), funded by the Gates Foundation, Wellcome Trust, and MasterCard, focused on R&D and scaling up COVID-19 treatments.^[6]

PDPPPs have effectively advanced R&D for neglected diseases, enhancing the availability of affordable and effective products for developing countries. However, their focus on specific areas limits their ability to fully address the need for affordable medicines for neglected illnesses. These limitations are:

●                 PPPs focus on diseases like tuberculosis and malaria but often overlook very neglected diseases, such as African trypanosomiasis and leishmaniasis, due to their smaller global impact;^[7]

●                 Even with developed products, distribution challenges persist. For example, praziquantel for schistosomiasis saw limited use despite low costs, due to weak distribution partnerships.^[8] PDPPPs' focus on core R&D further hinders access in low-resource areas;

●                 PDPPPs face funding shortfalls, with high R&D costs leaving neglected disease treatments stuck in development.^[9]

●                 Company involvement in PPPs is limited; of the Medicines for Malaria Venture's 14 projects, five lack industry partners, and only six companies are engaged in the remaining nine, with GlaxoSmithKline involved in three;^[10] and

●                 There is skepticism about profit-driven firms in partnerships, as they often prioritize developed markets over global access. Firms may seek influence, profits, and control, benefiting from tax breaks, market penetration, and legitimacy through associations like the UN,^[11] raising concerns about trade-offs and conditions.^[12]

Given the challenges and uncertainties surrounding product R&D, it is too early to determine if PPPs, particularly PDPPPs, can sustainably address the insufficient availability of drugs for neglected diseases. Their ability to tackle affordability and access issues remains uncertain. However, the prospects look promising.

“Pull” for development and marketing: advanced purchase commitments (APC)

Public and federal funding, along with PDPPPs, drive early-stage R&D for neglected diseases, while Advanced Purchase Commitments (APCs) provide market incentives for further development. Inspired by programs like the 1983 US Orphan Drug Act^[13] and the UK's meningitis C vaccine contracts^[14], APCs guarantee purchase prices for medicines, ensuring returns for developers and affordable access in low-income regions. APCs guarantee pre-set purchase prices for medicines, with sponsors like UN organizations covering most costs to ensure developer returns^[15] and affordable access for poor countries. Suppliers must then sell treatments affordably or license technology^[16] to promote accessibility and innovation.

During the COVID-19 pandemic, Gavi's COVAX Advance Market Commitment (AMC) enabled 92 low- and middle-income economies to access vaccines by guaranteeing a market for them^[17], Vietnam also received benefit from COVAX. In particular, on April ^{1, 2021,} Vietnam received its first supply of 811,200 COVID-19 vaccination doses delivered through the COVAX Facility.[18]

During a period from 2021 to 2022, Vietnam received approximately 51 million doses of COVID-19 vaccines through the COVAX Facility.[19] This amount of vaccines played an important role in the fight against COVID-19 in Vietnam, helping to largely prevent infection and spread, create community immunity, and, most importantly, protect against severe disease progression and death.

Other developing countries, like the Philippines, South Africa, and Indonesia, also signed Advance Purchase Commitments (APCs) with pharmaceutical companies to secure vaccine supplies, ensuring timely access during the global health crisis.^[20]

APCs offer several advantages:

●                 For Firms: They reduce economic uncertainty and guarantee demand and returns if products meet defined standards, despite scientific risks.

●                 For Product Development: They mobilize additional resources for clinical testing and encourage competition, leading to cost-effective, high-quality products. Donor funds are used efficiently, as payments are based on results rather than inputs.

●                 For Sponsors: Their expenditures are secure and cost-effective.

●                 For Consumers: APCs provide access to products at specified prices in the short term and at lower prices in the long term.

However, APCs face challenges, especially for early-stage products, including setting adequate specifications and prices, and the risk of “crowding out” existing “push” mechanisms. Late-stage commitments are more efficient but may still face issues like prioritizing profitable markets and incentivizing follow-on innovation.

Despite these critical issues, APCs can potentially replicate market-based incentives for developing-country diseases, enhancing availability and access to essential medicines. It's suggested to let the experiment proceed and make adjustments as needed.

Conclusion

TRIPS external melioration attempts are partially effective in improving drug access and availability for developing countries. However, they have their limitations:

●                 Short-term Solutions: Some initiatives, like donations, provide only temporary relief.

●                 Disease-Specific: Many efforts focus on specific diseases or domestic burdens.

●                 Country-Specific: Measures like differential pricing are limited to certain countries.

●                 Practical Challenges: Differential pricing requires market segmentation; PDPPPs often lack funds; PPPs rely on many partners; and APCs face “time inconsistency” and “crowding out” issues.

All of the above discussed measurements are merely attempts at improvement. It is advisable to enhance them, as they might temporarily alleviate the situation for some recipient countries and specific diseases, notably neglected diseases, which are also pertinent to industrialized nations, unlike extremely neglected diseases.

In order to improve pharmaceutical access in developing and least-developed countries, a collaborative effort among governments, international organizations, and both public and social sectors is essential. By modifying the TRIPS Agreement, enhancing local capabilities, and promoting transitions, the international community can ensure that technological advancements benefit everyone, not just a privileged few.-

[1] Widdus, Roy (2006), pp. 205, 206; Levine, Ruth et al. (2005), p. 17. See both references for a detailed list of all PDPPPs; and Medecins San Frontier (2001), p.23; Levine, Ruth et al. (2005), p. 19.

[2] Widdus, Roy (2006), p. 205. ; Levine, Ruth et al. (2005), p. 17.

[3] Widdus, Roy (2006), p. 211.

[4] Wheeler, Craig / Berkley, Seth (2001), p. 729.

[5] Coalition for Epidemic Preparedness Innovations (CEPI). (2020). Why we need a portfolio approach to COVID-19 vaccine development. Retrieved January 7, 2025, from https://cepi.net/why-we-need-portfolio-approach-covid-19-vaccine-development.

[6] National Academies of Sciences, Engineering, and Medicine. (2020). Private sector engagement in the COVID-19 response: Workshop summary. World Health Organization. Retrieved January 7, 2025, from https://hlh.who.int/docs/librariesprovider4/private-sector/nasem-workshop-ps-covid-response.pdf?sfvrsn=858dd554_11

[7] Trouiller, Patrice et al. (2002), p. 2193.

[8] Reich, Michael R. (2000), p. 3; Widdus, Roy (Z006), p. 219.

[9] Medecins Sans Frontieres - Website. Medical Innovation: Looking for alternative models.

[10] Trouiller, Patrice et al. (2002), p. 2192.

[11] Reich, Michael R. (2000), pp. 2, 3; Richter, Judith (2004): Public-private Partnerships for Health: A trend with no alternatives? P.46. In: Development., Vol. 47, No. 2. 2004, pp. 43-48.

[12] Richter, Judith (2004). R46; Trouiller, Patrice et al. (2002), p. 2192.

[13] Similar laws exist in Europe, Japan, Singapore and Australia. See: Medecins Sans Frontiers (2001), p. 25.

[14] "Advance contract" in the sense that it is a contract, which is made before the product is developed and produced.

[15] A market size of US $ 3 billion is recommended as this figure represents the average net present value of lifetime sales for the average pharmaceutical commercial products (as of 2004) adjusted to lower marketing costs. See: Glennerster, Rachel et al. (2006), p. 74.

[16] Kremer, Michael et al. (2005), p. 18, 20, 21; Glennerster, Rachel et al. (2006), p. 73.

[17] Gavi, the Vaccine Alliance. (2020, July 31). 92 low- and middle-income economies eligible to access COVID-19 vaccines through Gavi COVAX AMC. Retrieved January 7, 2025. https://www.gavi.org/news/media-room/92-low-middle-income-economies-eligible-access-covid-19-vaccines-gavi-covax-amc

[18] WHO Website (2021, April 1). First shipment of COVID-19 vaccine from COVAX Facility arrives in Viet Nam. https://www.who.int/vietnam/news/detail/01-04-2021-first-shipment-of-covid-19-vaccine-from-covax-facility-arrives-in-viet-nam

[19] UNICEF Website (2022, January 25). Viet Nam receives an additional 6.27 million COVID-19 vaccine doses donated by Germany, Luxembourg, Portugal and the United Kingdom through the COVAX Facility. https://www.unicef.org/vietnam/press-releases/viet-nam-receives-additional-627-million-covid-19-vaccine-doses-donated-germany

[20] GMA News Online (2021). Duque says deal sealed for 25M doses of Sinovac COVID-19 vaccine. Retrieved 7 January 2021. https://www.gmanetwork.com/news/topstories/nation/771173/duque-says-deal-sealed-for-25m-doses-of-sinovac-covid-19-vaccine/story/. The Jakarta Post (2020). "Sinovac vaccine has no critical side effects, BPOM says". Retrieved 7 January 2021. https://www.thejakartapost.com/news/2020/12/18/sinovac-vaccine-has-no-critical-side-effects-bpom-says.html.

[1] Beigbeder, Yves (2004), p. 96; Widdus, Roy (2006), p. 208; Global Forum for Health Research (2004). Executive summary xiv.

[2] Widdus, Roy (2006), p. 208; Global Forum for Health Research (2004). executive summary xiv.

[3] For a complete list of all partners see: StopTB Partnership - Website. Partners‘ Directory.

[4] StopTB Partnership - Website. About the StopTB Partnership.

[5] See: IPPPH (2002): An Inventory of Health Public-Private Partnerships in South Africa. A Report Commissioned by The Initiative on Public-Private Partnerships for Health.

[6] StopTB Partnership - Website. Working Group on New TB Drugs - Team.

[7] See: StopTB Partnership (2007): Global TB Research and Development Projects. October 2007.Working Group on New TB Drugs.

[1] Reich, Michael R. (2000): Public Private Partnerships for Public Health, p.1-2. In: Health Administrator. The official Journal of the Indian Society of Health Administrators. Vol. XXI, No. 1-2, July and December 2008, pp. 128-132; Bellad, Mrutyunjaya (2005): Public-private partnership in health research: experiences from a community-based research project in South India, p. 4; Widdus, Roy(2006), p. 208. Medecins Sans Frontiers (2001), p. 27.

[2] Widdus, Roy (2006), p. 205; Widdus, Roy (2001): Public-private partnerships for health: their main targets, their diversity, and their future directions. Policy and Practice. Theme Papers, p. 713. In:WHO(2001): Bulletin of the World Health Organization. Vol. 79. 2001, pp. 713-720.

[1] US tax laws even permit sufficient tax savings so that donating corporations have only little or even no own costs. See: Scherer, Frederic M. / Watal, Jayashree (2002), p. 377, 378; Liebig, Klaus (2005), p. 215; WHO (2006), p. 113; Scherer, Frederic M. / Watal, Jayashree (2002), P. 376; WHO/WTO (2001), p. 221; Watal, Jayashree (2000b), p. 10.

[2] Gavi, the Vaccine Alliance. (n.d.). COVAX vaccine roll-out. Retrieved January 7, 2025. https://www.gavi.org/covax-vaccine-roll-out

[3] Gleeson, D., Townsend, B., Tenni, B. F., & Phillips, T. (2023). Global inequities in access to COVID-19 health products and technologies: A political economy analysis.

[4] Watal, Jayashree (2000b), p. I0; Thomas, Anna (2002): Street Price: A Global Approach to Drug Pricing for Developing Countries, p. 289, 290. In: Granville, Brigitte (Ed.) (2002): The economics of essential medicines. Royal Institute of International Affairs. International Economics Program: London, p. 275-300. Some donation programs, like the MDP mentioned above, also set up good transport systems, train local healthcare workers, and help with giving and tracking treatments. See: Sturchio, Jeffrey L. / Colatrella, Brenda D. (2002), p. 270.

[5] Ochola, Dorothy (2002): Challenges in Widening Access to HIV-AIDS related Drugs and Care in Uganda, p. 202. In: Granville, Brigitte (2002): The economics of essential medicines. Royal Institute of International Affairs. International Economics Program: London, p. 198-205 ; Thomas, Anna(2002), p. 289.

[6] Thomas, Anna (2002), p. 289.

[7] Ochola, Dorothy (2002), p. 202.

[8] Widdus, Roy (2006): Product Development Partnerships on "Neglected Diseases": Intellectual Property and Improving Access to Pharmaceuticals for HIV/AIDS, Tuberculosis and Malaria, p. 208. ln: Roffe, Pedro / Tansey, Geoff / Vivas-Eugui, David (2006): Negotiating Health: Intellectual Property and Access to Medicines. Earthscan: London, pp. 205- 226.

[9] WHO (2006), p. 46.

[10] Glennerster, Rachel, Kremer, Michael, & Williams, Heidi (2006). Creating Markets for Vaccines. Innovations Case Discussion: International AIDS Vaccine Initiative, Innovations, 1(1), 67-79. Medecins Sans Frontiers (2001), pp.24-25.

[11] Glennerster, Rachel et al. (2006), p. 71.

[12] Medecins Sans Frontiers (2001), pp. 19-20.

[13] The organisation Universities Allied for Essential Medicines (UAEM) critically deal with the issue of university patenting and licensing policies and their responsibility to improve global access to essential medicines. See: Universities Allied for Essential Medicines (UAEM) - Website.

[14] Medecins Sans Frontiers (2001), p. 20; WHO (2006), pp 40, 55, 56; Liebig. Klaus (2005), pp. 220,221.

[15] Global Forum for Health Research (2004): The 10/90 report on Health Research 2003-2004. Executive summary xiv.

[16] WHO (2006), pp. 43,44,416.

[17] Levine, Ruth et al. (2005), p. 17.

[18] Medecins Sans Frontiers (2001), p. 22; Levine, Ruth et al. (2005), p. 19; Liebig, Klaus (2004), p.223.

[19] Caulfield, T., & Ogbogu, U. (2015). The commercialization of university-based research: Balancing risks and benefits. BMC Medical Ethics, 16, Article 70. https://doi.org/10.1186/s12910-015-0064-2

[20] Keestra, S., Rodgers, F., Osborne, R., & Wimmer, S. (2022). University patenting and licensing practices in the United Kingdom during the first year of the COVID-19 pandemic. Global Public Health, 17(5), 641–651. https://doi.org/10.1080/17441692.2022.2049842

[1] R&D and other fixed costs are already allocated to high- and middle-income countries, because low- income countries represent only a small share of the global pharmaceutical market. See: Gamharter, Katharina (2004), p. 249: WHO-WTO (2001): Differential Pricing and the Financing of Essential Drugs, p. 219. ln: Granville, Brigitte (Ed.) (2002): The Economics of Essential Medicines, pp. 209-231.

[2] International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). (2024). Access to medicines and vaccines is about much more than price. Retrieved January 7, 2025. https://www.ifpma.org/insights/access-to-medicines-and-vaccines-is-about-much-more-than-price/

[3] Donald W Light / Joel Lexchin. (2021). The costs of coronavirus vaccines and their pricing. The costs of coronavirus vaccines and their pricing.

[4] WHO (2006), p. lll; Liebig, Klaus (2005), p. 209-2ll; Gamharter, Katharina (2004). 249, 250;Watal, Jayashree (2000b), p. 14.

[5] There is a controversy, if such price discounts and negotiations should be kept secret in order not to have implications on price-spillovers on referential pricing. Liebig, Klaus (2005), p. 210; Watal, Jayashree (2000b), p. 14.