What COVID-19 Demonstrates About the Willingness to Issue Compulsory Licences

  • February 27, 2021
  • Anna-Marie Morrish

Science and innovation can profoundly affect our capacity to prevent, detect, and treat disease.  Now, more than ever, the world has clear insight into the vital role of research and discovery in protecting our collective health and wellbeing.  While it may not be difficult for the public or policy makers to generally agree that good ideas should be rewarded, the perception of the importance of patents becomes more convoluted when they are related to pharmaceuticals, particularly pharmaceuticals that are expensive and potentially life saving.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), a multilateral treaty whose drafters aspired to create consistency and predictability in intellectual property protection, came into force in 1995. TRIPS was an important step in IP protection for pharmaceuticals, as it required signatories to extend patent protection to these products. Through Article 31, TRIPS also provided flexibility for signatories to use the subject matter of a patent without authorization of the patent holder under some circumstances – a permission more commonly referred to as a compulsory license. However, despite their availability under TRIPS, few compulsory licenses were issued post-TRIPS until the 2000s.

The 80s and 90s were host to a devastating HIV/AIDS pandemic when little was known about transmissibility and prevention. The development of antiretrovirals (“ARVs”), and specifically the use of triple ARV therapy, fundamentally altered the lives of people who received an HIV diagnosis, as ARVs offered hope from what was once a critical diagnosis. However, the prohibitively high cost of these drugs proved to be a daunting barrier to access in developing countries, and discussions around the use of compulsory licenses sparked intense debate and disagreement. This led to the adoption of the Doha Declaration in 2001 which clarified the availability of compulsory licenses for protecting public health.[1] The addition of Article 31bis to TRIPS further extended the flexibility to use compulsory licenses for non-domestic markets in circumstances where a country has reduced or no manufacturing capacity.

Notwithstanding the clarification of TRIPS, uncertainty and controversy continued to accompany compulsory licensing. For example, in 2006 and 2007, Thailand began importing two generic ARVs from India under compulsory licenses: Merk’s efavirenz and Abbott Laboratories’ combo ARV Kaletra. Thailand faced relatively immediate backlash for these decisions.  After attempts to convince Thailand to rescind these licenses were unsuccessful, the United States placed Thailand on the Special 301 Priority Watch List. The Special 301 Report, published by the Office of the United Sates Trade Representative, identifies countries who are not adequately or effectively protecting and enforcing intellectual property rights, while the Priority Watch List identifies those countries which present the most pressing concerns, and which may be subject to retaliatory actions by the United States. Additionally, Abbott Laboratories withdrew medications awaiting registration in Thailand and announced that it would cease releasing new medicines in the country.[2] When Brazil issued a compulsory license for efavirenz in 2007, the United States filed a complaint with the WTO Dispute Settlement Body,[3] a complaint that was subsequently dropped but could have resulted in sanctions against Brazil.

Following TRIPS and the Doha Declaration there was a proliferation of publications warning about the potential impacts of compulsory licensing. The threat of compulsory licensing led many academics to speculate whether compulsory licensing would become commonplace, and whether or not it would stymie innovation. The reactions to, and consequences faced by, countries that issued compulsory licenses is demonstrative of the policy considerations a country faces when undertaking an assessment of whether or not a compulsory license is the preferable route in times of public health crisis.

The response to the global COVID-19 pandemic has been illuminating in this regard. Since the start of the pandemic, a lack of resources has been a problem ubiquitous among countries, regardless of wealth. Doctors and nurses raised the alarm on the glaring lack of personal protective equipment (“PPE”). N95 masks, in particular, became a hot topic as they were in such scarce supply that hospitals kept them under lock and key. Even regular surgical masks were in short supply, so much so that grass roots efforts led to local drives to redirect resources to hospitals from non-urgent health offices and any other businesses that used them. Despite that many countries, including Canada, issued emergency legislation to provide for easier routes to compulsory licensing, not a single compulsory license was issued for PPE, which was, and still is, undoubtedly one of the most important pieces of defence that we have in controlling spread.

Since December of 2020, vaccines have started to receive approval for use, but supply is falling short of the urgent demand. Manufacturing these vaccines is one of the rate-determining steps in controlling the pandemic that has cost over 2.5 million lives as of the date of this article.[4] It is unclear whether signatories to TRIPS will be open to utilizing this flexibility for vaccines. A proposal brought to the WTO to waive IP rights for COVID-19 drugs and vaccines was to be considered at the WTO General Council meeting in December of 2020. The WTO delayed coming to a decision on the proposal after it was met with resistance from several wealthy countries including Britain, the United States and Switzerland.[5] While this proposal would negate the need for individual countries to issue compulsory licences, the response to the proposal may be indicative of the stance of member states regarding overriding IP protection generally.

Furthermore, it does appear that at least some vaccine manufacturers are willingly engaging in negotiations for voluntary licenses to increase their manufacturing capacity, and this might ward off the use of compulsory licences. For example, the Serum Institute of India has entered into agreements to co-manufacture COVID-19 vaccines with AstraZeneca (whose vaccine has been approved for use) and Novavax.[6]

It is clear that the bar for use of compulsory licensing is high, and that many policy considerations come into play when deciding whether or not to exercise this right. Even in light of the recent obstacles faced by Canada in accessing vaccines, and that the government has announced their support for the domestic manufacture of vaccines, it is unclear whether or not compulsory licenses will be issued.[7]

 

[1] United Nations Secretary-General’s High Level Panel on Access to Medicines, “Report of the United Nations Secretary-General’s High Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies”, 14 September 2016, online at: https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf

[2] Donald Harris, “TRIPS After Fifteen Years: Success or Failure, as Measured by Compulsory Licensing” (2011) 18:2 J. Intell. Prop. L. 367. 

[3] Beatrice Stirner, “Learning From Practice: Compulsory Licensing Cases and Access to Medicines” (2012) 1:5 Pharm. Pat. Analyst 555.

[4] Henrick Pettersson, Byron Manley & Sergio Hernandez, “Tracking Coronavirus’ Global Spread” (2021) CNN Health, online at: https://www.cnn.com/interactive/2020/health/coronavirus-maps-and-cases/

[5] Emma Farge & Stephanie Nebehay, “WTO Delays Decision on Waiver on COVID-19 Drug, Vaccine Rights” (10 December 2020, Reuters, online at: https://www.reuters.com/article/us-health-coronavirus-wto-idUSKBN28K2WL

[6] https://www.pri.org/stories/2021-02-04/how-india-s-serum-institute-became-covid-19-vaccine-powerhouse

[7] Thomas Walkom, “Compulsory Licensing Would Allow Ottawa to Authorize Generic Copies of the COVID-19 Vaccines, 4 February 2021, The Toronto Star.

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