Science for All: When Access to Medicines Gets Tangled in Bureaucratic Red Tape

The Abstract Team,

Cover Image: Isabelle Aish, February 2026

By: Iarina Murasan, Contributing Writer (original version published in The Dose, a UAEM newsletter)

Innovation blooming in the medical field make it seem like technological evolution is at an all-time high. Medical boundaries are indeed being pushed every day, but solutions to the world’s most pressing health needs do not always reach populations who need them.

In Canada, the biomedical manufacturing field becoming more and more present. A notable example is Biolyse Pharma, an Ontario-based manufacturer and distributor of pharmaceutical products, one of a few Canadian-based companies able and allowed to manufacture injectable drugs.1,2 A case of interest is their steadfast response to the international COVID-19 vaccine shortage.

First attempts at an international collaboration for vaccine

During the pandemic, Bolivia experienced important vaccine shortages. In 2019, after confronting political unrest and economic troubles, Bolivia was hit with the COVID epidemic, with pressure to maintain the economy resulting in a loosening of public health safety measures.2,3 This led to a near-collapse of the healthcare system, with healthcare workers going on strike due to exhaustion and patients travelling long distances to find oxygen tanks and hospital beds.3 Bolivia did not have the domestic capacity to produce vaccines and lacked the buying power to secure deals with manufacturers, who prioritized pre-orders from wealthier countries (i.e. vaccine nationalism).2 These limitations, common to many other low- and middle-income countries (LMICs), prevented Bolivia from independently responding to its population’s needs.4

In February 2021, Bolivia made the World Trade Organization (WTO) aware of its intent to buy COVID-19 vaccines from Canada’s Biolyse Pharma, who was ready to manufacture the vaccine and pledged to provide the first 15 million doses to Bolivia.4,6 However, Biolyse needed to obtain a voluntary license to be able to make and sell their patented product.3 Unfortunately, in March 2021, Biolyse was declined the voluntary license from Johnson & Johnson (J&J), the patent owners of the desired vaccine.3 Despite this refusal, Biolyse and Bolivia kept pursuing J&J’s vaccine because it required only one dose, an advantage for the goal of vaccinating as many people as possible and would be easier to manufacture for a generic manufacturer like Biolyse.3

Alternatives and a tentative transaction agreement

Biolyse now needed to find a way to circumvent J&J’s patent, which was protected among WTO members by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.2,6,7 A potential solution was to obtain TRIPS waiver, which could be put to a vote at the WTO; but it was unlikely to pass because it required that all WTO countries agree to it.6,16 Seeing as a country like Canada, who was vocal about its support of global health, was unwilling to clearly support the waiver, the waiver was not the most effective path.2,6 The next best route of action was to apply for a compulsory license via Canada’s Access to Medicines Regime (CAMR), set up in 2004 to circumvent intellectual property laws during emergencies, making J&J’s consent of their patent’s use unnecessary.3,4,6 For CAMR to have worked, the vaccine had to be added to Schedule 1, the list of medicines to which CAMR applies.3 However, that process was unnecessarily arduous, filled with dead-ends and new, “cumbersome” requirements.3 In the end, the vaccine was not added to Schedule 1, and Biolyse’s request for a compulsory license was unfruitful.3

In May 2021, Bolivia and Biolyse confirmed their transaction agreement with the WTO for the acquisition of up to 15 million doses, at around half of J&J’ not-for-profit price.3,6,12,17 Still, production could not start as the patent barrier had not been lifted, neither by a voluntary license from J&J nor by the CAMR pathway.6 Even so, in May 2021, Canada’s then-Minister of Small Business, Export Promotion and International Trade, Mary Ng, stated that Canada has “been a leader in the global effort to ensure there is equitable access to successful vaccines.”6

To answer the confusion surrounding this seemingly unusable CAMR pathway, Richard Gold, a McGill law professor, explained that the desire to protect innovation and to keep pharmaceutical companies happy contributed to the reluctance of the federal government to take concrete action.6 John Fulton, Executive Vice-President of Biolyse, corroborated this analysis, by adding that pharmaceutical companies pressured the federal government into tightening the knots on the CAMR by leveraging delays in their vaccine production for Canada.3
While protecting intellectual property and innovation are crucial in scientific development, it is important to note that open science is constructive to innovation as well. In fact, basic research done at the University of British Columbia contributed to the foundations of the COVID vaccine.6

International aid – a generous push, but insufficient push

As LMICs were struggling to access COVID-19 vaccines due to high prices or unavailability, international aid efforts attempted to help by aiding vaccine supply.5,12 However, international organizations like the COVID-19 Vaccines Global Access Initiative (COVAX) were not as efficient as they could have been.12 While a striking CAD$8.3 billion of public funds were used to develop the mRNA vaccines, COVAX paid Pfizer and Moderna five times the estimated production price.12 This supply monopoly, alongside higher income countries quickly purchasing the bulk of the supply, contributed to the limitations of organized international efforts like COVAX.12 Additionally, donations were not a long-term solution, according to Maira Macdonal, Bolivia’s ambassador to the WTO.2 Indeed, COVAX-like programs partially failed because of systemic barriers.13 Wealthy countries could still hoard doses, vaccines would expire without proper transport and storage, and healthcare workers lacked necessary equipment and training.13 Most importantly, reliance on international aid undermines long-term health security in LMICs.13

Dismantling systemic barriers and moving medicine forward in underprivileged communities

If LMICs had the capacity to manufacture and distribute this technology, laboratories and manufacturers would be able to address local needs and diseases without depending on facilities in the Global North.8 Furthermore, local development would be economically beneficial and could build trust with the community it would serve, unlike foreign corporations, who have been known to take advantage of underprivileged communities.8

Although diplomatic acts and political will are difficult to influence, members of an engaged scientific community can make a difference and build a more sustainable future. An inspiring example is the work of Drs. Katalin Karikó and Drew Weissman, 2023 Nobel Prize laureates in Physiology or Medicine. Dr. Weissman was a guest lecturer at the 2025 Trottier Symposium, hosted by the McGill Office for Science and Society, and spoke of the importance of making RNA technology accessible worldwide.8,14

In an interview with Dr. J. Bowen, it was specified that he University of Pennsylvania (UPenn), where Dr. Weissman conducts RNA research, supports the dissemination of knowledge, and their researchers have the academic freedom to engage with international collaborators. Seeing as mRNA technology can be applied to treat various conditions, Dr. Weissman supports collaborative research with experts on specific disease models for more efficint and accessible results.8 In more concrete terms, Dr. Weissman has been working with the Chula Vaccine Research Center in Thailand to increase their ability to develop mRNA vaccines, which would benefit Thailand and neighboring LMICs.8,9

Additionally, to overcome the intellectual property and patent law limitations to global health, universities can work out more non-exclusive patent deals (Dr. J. Bowen, personal communication, November 20th, 2025).8 For example, Pfizer/BioNTech and Moderna have a non-exclusive license on certain UPenn mRNA vaccine technologies, allowing countries like Albania, Bangladesh, and Bulgaria to use the licensed technology.15

Getting involved in health equity

In the end, the Bolivia-Biolyse case did not end favorably, but we must learn from it to ensure we can efficiently move forward with health equity and expand access to solutions we already have. While basic research and clinical trials are crucial in ensuring medicines hit the market and assist people in their health journey, access to those solutions is just as important. What good does a cure do if it sits in a cabinet?

If you want to go put your shoulder to the wheel, you can start by joining organizations or associations within your academic community whose goals align with global health and equity. For example, the Universities Allied for Essential Medicines (UAEM) is powered by the belief that drugs developed in publicly funded university laboratories should be accessible to a wider public.11 If you want to have an impact on equitable access to life-saving drugs, I urge you to explore UAEM’s mission and contributions, which include McGill-centered initiatives to promote transparency and solidarity in healthcare.11

References

  1. About us. (n.d.). Biolyse Pharma. Retrieved November 7, 2025, from https://biolyse.com/about-us/
  2. Lock, H. (2021, August 2). Bolivia could unlock new access to Life-Saving COVID-19 vaccines — but needs Canada to grant a license. Global Citizen. https://www.globalcitizen.org/en/content/bolivia-canada-patents-covid-19-vaccines-trips/
  3. Abbas, M. Z., PhD & South Centre. (2021). Canada’s political choices restrain vaccine equity: the Bolivia-Biolyse case. In Research Paper. https://www.southcentre.int/wp-content/uploads/2021/09/RP136_Canadas-Political-Choices-Restrain-Vaccine-Equity-The-Bolivia-Biolyse-Case_EN-1.pdf
  4. Lexchin, J. (2023). Canada and the pharmaceutical industry in the time of COVID-19. International Journal of Social Determinants of Health and Health Services, 53(4), 508–517. https://doi.org/10.1177/27551938231195434
  5. Blanco, B. (2021, September 28). With one simple decision, the Canadian government can save lives. Al Jazeera. https://www.aljazeera.com/opinions/2021/9/28/the-canadian-government-can-save-bolivian-lives
  6. Khan, A. (2021, October 6). Canada lacks ‘political will’ to waive COVID-19 vaccine patents, Bolivian minister says. Global News. https://globalnews.ca/news/8243635/bolivian-minister-canada-covid-vaccine-waiver/
  7. WTO. (n.d.). WTO ANALYTICAL INDEX. In TRIPS Agreement – Article 31bis (Practice) (pp. 1–3). https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art31_bis_oth.pdf
  8. McGill Office for Science and Society. (2025, October 22). The Genesis of the COVID Vaccine: The Path to the Nobel Prize (Trottier Symposium) [Video]. YouTube. https://www.youtube.com/watch?v=tmF0CDqDu-Y
  9. About us – Chula Vaccine Research Center. (n.d.). https://www.chulavrc.org/about-us/
  10. About us | INNOVARTE ONG. (n.d.). https://www.corporacioninnovarte.org/en/about-us/
  11. About UAEM — Universities Allied for Essential Medicines. (n.d.). Universities Allied for Essential Medicines. https://www.uaem.org/mvv
  12. Caroline.Leal. (2021, July 28). Vaccine monopolies make cost of vaccinating the world against COVID at – – Oxfam Canada. Oxfam Canada. https://www.oxfam.ca/news/vaccine-monopolies-make-cost-of-vaccinating-the-world-against-covid-at-least-5-times-more-expensive-than-it-could-be/
  13. Dagovetz, M. et al., Global COVID-19 vaccination challenges: Inequity of access and vaccine hesitancy, Journal of Medicine, Surgery, and Public Health, Volume 6, 2025, 100197, ISSN 2949-916X, https://doi.org/10.1016/j.glmedi.2025.100197
  14. Ewing, R. (2024, January 8). How Penn Medicine is changing the world with mRNA. Penn Today, https://penntoday.upenn.edu/news/how-penn-medicine-changing-world-mrna
  15. Larbi, A., & Park, C. (2023). Intellectual property. https://cdn.who.int/media/docs/default-source/immunization/mrna-ttp/april-2023/1_ip_larbi_chan.pdf?sfvrsn=3764b678_1
  16. TRIPS Waivers and Pharmaceutical Innovation | CSIS. (n.d.). https://www.csis.org/blogs/perspectives-innovation/trips-waivers-and-pharmaceutical-innovation
  17. Pagliarulo, N. (2021, October 19). J&J foresees end to not-for-profit sales of coronavirus vaccine. BioPharma Dive. https://www.biopharmadive.com/news/johnson-johnson-vaccine-not-for-profit-price/608477/
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