Science for All: When Access to Medicines Gets Tangled in Bureaucratic Red Tape and Why Local Production is Critical for Health Security
By: Iarina Murasan, UAEM at McGill University Access Team
Technological evolution is at an all time high and numerous scientific fields are blooming with potential. We push medical boundaries every day, but in reality, solutions to the world’s most pressing health needs do not always reach those who need them.
After experiencing hardships, it is important to look back to make sure we do not stumble on the same obstacles in the future. This is why I wish to bring up the pandemic again, this time exploring a case of intellectual property logistics and showing how legal barriers to medicines access is not abstract, but a real complexity we face.
The biomedical manufacturing field is very present in Canada. A notable example is Biolyse Pharma, an Ontario-based manufacturer and distributor of pharmaceutical products.[1] They are one of a few Canadian-based companies able and allowed to manufacture injectable drugs.[2] Their history started with the discovery of a groundbreaking, efficient method to extract the active ingredient of Paclitaxel, a cancer drug, from the yew tree, and they are headed towards expanding their production capabilities to include biologics (large-molecule drugs, like monoclonal antibodies).[1] Biolyse mainly supplies oncological treatments, both locally and internationally.[1] In this case study, their steadfast response to the international COVID-19 vaccine shortage is of interest.
After confronting political unrest and subsequent economic troubles in 2019, Bolivia was hit with the COVID pandemic.[2] The shaky healthcare system was overwhelmed, and the country saw as many as 2,000 daily confirmed cases in 2020.[3] Then, pressures to maintain the economy resulted in a loosening of public health safety measures.[3] This led to a near-collapse of the healthcare system, with healthcare workers going on strike due to the exhausting working conditions and patients travelling long distances to find oxygen and hospital beds.[3] Bolivia did not have the manufacturing facilities to make the vaccines required to protect its population.[4] This limitation is common in many low- and middle-income countries (LMICs) and has contributed to the lack of vaccines in Bolivia, who does not have the domestic capacity to produce vaccines and lacks the buying power to secure deals with manufacturers, who prioritize pre-orders from wealthier countries (i.e. vaccine nationalism).[2] In fact, as of mid-2021, more than half of available doses were distributed to high-income countries, while the remaining 84% of the global population was left with the other half of vaccine doses.[13]
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, to begin the manufacturing process, Biolyse would need to obtain a voluntary license from Johnson & Johnson (J&J), the patent owners of the vaccine in question.[3] After obtaining manufacturing authorizations, Biolyse would be able to export the vaccine to countries that authorize the export under Article 31bis of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, including Bolivia (a WTO Member).[2,3,7] In March of the same year, Biolyse requested the voluntary license from J&J, who declined the request.[3] Despite this refusal, Biolyse and Bolivia pursued the J&J avenue because J&J’s viral-vector vaccine only requires one dose, an advantage when the goal is vaccinating as many people as possible.[3] It is also simpler to make for generic manufacturers like Biolyse, for whom it would take too long to equip themselves with the technology required for mRNA vaccine production.[3]
Without J&J’s cooperation, Biolyse needed to find a way to circumvent J&J’s patent, which is protected by the TRIPS.[6] A TRIPS waiver, which could be put to a vote at the WTO, could work on paper, but it is unlikely to pass because all WTO countries need to agree to it.[6,16] When a country like Canada, who is vocal about its support of global health, is unwilling to support the waiver, waiting for the waiver to happen was not the most effective path.[2,6] The next best route of action for Biolyse was to apply for a compulsory license via Canada’s Access to Medicines Regime (CAMR), set up in 2004 to serve in these exact circumstances and makes J&J’s consent of their patent’s use unnecessary.[3,4,6] For this pathway to be used efficiently, the COVID vaccine had to be added to Schedule 1, the list of medicines for which CAMR applies.[3] While Schedule 1 can be amended, the process was unnecessarily arduous and filled with dead-ends, unclear instructions, few resources, inaccessible forms, and new, “cumbersome” requirements.[3] The end-result was that the COVID vaccine was not added to Schedule 1, and Biolyse’s request for a compulsory license from March 2021 was unfruitful.[5] Compulsory licenses provide legitimate mechanisms to circumvent intellectual property laws during health emergencies to protect public health, but those routes of access many times, as in the case with Bolivia, have proven to be close to unusable in an emergency scenario.[5]
In May 2021, Bolivia and Biolyse confirmed their official transaction agreement with the WTO for the acquisition of up to 15 million doses, at around US$3 to US$4 per dose.[3,6] This price point is even lower than the not-for-profit price offered by J&J, between US$5-8 per dose.[12,17] Despite the signed deal with Bolivia, Biolyse was unable to start production, as the patent barrier to manufacturing the vaccine had not been lifted, neither by a voluntary license nor by the CAMR pathway.[6] Yet, 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]
Although the CAMR pathway offers a mechanism for Canada to be a global leader in providing health technologies to low- and middle-income countries during health emergencies, political will seems to be lacking, as noted by both Bolivian and Biolyse officials.[6] Richard Gold, a McGill University law professor, explains that the desire to protect innovation, and to keep pharmaceutical companies happy and get them to invest in Canada may contribute to the reluctance of the federal government to take concrete action.[6] In reality, 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] To ensure that the profits from the global pandemic kept soaring, pharmaceutical companies pressured governments into tightening the knots on the red tape.[3] J&J told Justin Trudeau, the then-Prime Minister of Canada, that there could be “potential production delays for their one-shot vaccine option.”[3] With elections coming up, the federal government thought it was best to avoid using CAMR, according to John Fulton, Executive Vice-President of Biolyse, to ensure vaccines kept flowing in Canada.[3]
While Canadian officials made statements at the WTO about willingness to help, the importance of equity, and setting up laws to loosen patent protection during crises, missed opportunities to act on those promises accumulated and deaths occurred in LMICs.[3]
As LMICs were struggling to secure access to COVID-19 vaccines due to barriers such as price or availability, international aid efforts helped provide some doses.[5,12] However, donations and international organizations like the COVID-19 Vaccines Global Access Initiative (COVAX) were not as efficient as they could have been in helping countries fight vaccine inequity in the short term.[12] An important reason was a high price point, which didn’t reflect estimated production costs and fed into vaccine inequity.[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 from countries who had enough doses was not the long-term solution to solve Bolivia’s crisis, according to Maira Macdonal, Bolivia’s ambassador to the WTO.[2] Indeed, COVAX-like programs did not fulfill their goal of increasing vaccine access because systemic barriers are still present.[13] Wealthy countries could still hoard doses, vaccines were likely to expire if donation recipients were not equipped with the proper transport and storage infrastructure for vaccines, and healthcare workers still lacked the necessary equipment and training to face the treatment demand in their countries.[13] Most importantly, reliance on international aid and voluntary donations undermines long term health security in LMICs, hindering countries from fully addressing public health needs.[13]
Moving forward, it is critical to learn from the experience of Bolivia and ensure that intellectual property barriers continue to encourage innovation but do not stand in the way of public health, particularly during health emergencies. In addition to establishing clear and effective pathways for compulsory licensing, strengthening the ability of LMICs to respond to their country’s health needs by bolstering domestic vaccine production must be a priority.[2]
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, a very diverse and multipotent resource, accessible worldwide.[8] RNA vaccines could be used for a plethora of diseases, from infections to cancer and autoimmune diseases.[8,14]
If LMICs have the capacity to manufacture and distribute this technology, laboratories and manufacturers will 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]
The University of Pennsylvania (UPenn), where Dr. Weissman conducts RNA research, supports the dissemination of knowledge to facilitate access to medicines, and their researchers have the academic freedom to pursue this goal and engage with international collaborators as well (Dr. J. Bowen, personal communication, November 20th, 2025). Seeing as mRNA technology can be applied to treat various conditions, Dr. Weissman supports collaborative research with experts on specific disease models for more efficient research and more 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 neighbouring 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.[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] According to Dr. J. Bowen from UPenn’s Center for Innovation (personal communication, November 20th, 2025), these non-exclusive licenses are one of the simplest ways to make key technologies available to other parties.
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 is a cure if it sits in a cabinet? If you want to 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. I was introduced to this topic at the 2025 Universities Allied for Essential Medicines (UAEM) North America Conference by Luis Villarroel, intellectual property advisor to the Ministry of Education in Chile and founder and director of the NGO Innovarte.[10] He spoke of the power of intellectual property and shone light on what is often a forgotten but powerful aspect of healthcare advocacy. 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
About us. (n.d.). Biolyse Pharma. Retrieved November 7, 2025, from https://biolyse.com/about-us/
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/
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
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
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
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/
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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
About us – Chula Vaccine Research Center. (n.d.). https://www.chulavrc.org/about-us/
About us | INNOVARTE ONG. (n.d.). https://www.corporacioninnovarte.org/en/about-us/
About UAEM — Universities Allied for Essential Medicines. (n.d.). Universities Allied for Essential Medicines. https://www.uaem.org/mvv
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/
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
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
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
TRIPS Waivers and Pharmaceutical Innovation | CSIS. (n.d.). https://www.csis.org/blogs/perspectives-innovation/trips-waivers-and-pharmaceutical-innovation
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/