How Medicines Law & Policy is Aiding the Covid-19 Response

The Covid-19 pandemic has laid bare concerns about access to medicines and vaccines to address the pandemic. Unprecedented research efforts are under way to develop new tools. In particular, Covid-19 vaccines that are essential to save lives and end the pandemic. The question of how to ensure that these products will be universally available is becoming pressing. ML&P experts have been helping to respond to this question with explanations of policy options for governments and support for key global initiatives that will encourage and facilitate the sharing of intellectual property related to Covid-19 technologies. See below for ML&P insight (in the form of blogs or briefs), useful tools for governments seeking to use flexibilities in the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to increase access to medical technology for Covid-19, and important initiatives ML&P is supporting. ML&P is also updating its TRIPS Flexibilities Database to include Covid-19 related instances.

Featured: Technical briefing papers

Recent Articles on Covid-19

Protecting Public Health through Technology Transfer: The Unfulfilled Promise of the TRIPS Agreement

This article was previously published by the Health and Human Rights Journal. The scrambling for access to COVID-19 vaccines by developing countries has reignited the...

ML&P’s Comments to the Intergovernmental Negotiating Body (INB) on the Zero Draft of the...

These remarks were delivered on the occasion of the fourth meeting of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement...

Medicines price transparency: Ground still left to cover

Parts of this blog were previously published in the Lancet Regional Health Europe Secret medicines prices are hotly debated as European health systems struggle to...

Wrapping up 2022 with some noteworthy medicines, law and policy events

Welcome to our annual, highly biased overview of noteworthy events in the field of medicines law and policy. In 2022, Covid-19 remained a central concern...

Seven recommendations for sharing intellectual property, know-how and technology – report of Global Expert...

Negotiators of a Pandemic Treaty should heed the recommendations, published 15 July in the BMJ Global Health, to design a fair global system for...

WTO Covid-19 TRIPS Decision: Some observations

This morning, 17 June at 5 AM the 12th World Trade Organization (WTO) Ministerial Conference (MC12) approved a package of decisions and declarations. The...

Proposed TRIPS waiver a hollow diplomatic compromise with little practical impact

In October of 2020, 9 months into the pandemic, fearing conflicts over intellectual property (IP) related to medical measures to fight the pandemic,  India...

The US NIH will share technology with WHO to fight the pandemic

The US National Institutes of Health today committed to sharing several technologies with a World Health Organization body tasked with increasing access to Covid-19...

With technology transfer, 120 companies in low- and middle-income countries could manufacture mRNA vaccines

Recent reporting from the British Medical Journal (BMJ) has revealed efforts by BioNTech – the technology firm behind Pfizer’s projected $100 billion in Covid-19...

Wrapping up 2021 – some noteworthy medicines law and policy events

Welcome to the annual end of the year blog, our highly biased overview of noteworthy events in the field of medicines law and policy....

ML&P in the News

Medicines Law & Policy experts have been present in the news over the last weeks, helping clarify what needs to happen to respond to COVID-19. A selection of articles is available below.


Ellen 't Hoen's op-ed in Nature Medicine on market exclusivities and Covid-19

December 2021:

November 2021:

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May 2021:

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March 2021:

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January 2021:

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December 2020:

November 2020:

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Relevant ML&P Tools

COVID-19 has renewed interest in use of flexibilities in international law that can help governments increase access to medicines for their citizens. Our set of tools below can facilitate their use. For a flow chart that can help determine which tool is relevant to a particular country’s situation, see here.

Government Use Licences can allow governments to make use of a patented technology to treat Covid-19, even without patent holder permission.

Special compulsory licences for export (or “Article 3bis”) are useful in cases where there is inadequate national capacity to manufacture medicines.

 Least Developed Countries (LDCs) can benefit from special intellectual property waivers to facilitate access to technology for the Covid-19 response. 

Initiatives ML&P is supporting

Below are the important COVID-19 response initiatives that ML&P is committed to helping move forward.

Creation of a Covid-19 Technology Pool

Medical innovation is urgently needed to develop and produce tools to fight the pandemic; to facilitate this, the creation of a technology pool was proposed to the WHO by Costa Rica on 23 March. This mechanism would gather in one place and make available knowledge related to prevention, detection and treatment of Covid-19. It was endorsed on 27 March in an open letter to the WHO signed by nearly 100 public health organisations and experts, and since momentum has been growing.

On 3 April, the Board of the Medicines Patent Pool and UNITAID decided to expand MPP’s mandate to include health technology to support a Covid-19 response globally. And on 6 April WHO Director-General Dr Tedros Adhanom Ghebreyesus said he supported the proposal to create a pool and would work with Costa Rica to finalise details.

On 7 April, the Dutch Minister of Health offered to help WHO create the Covid-19 pool, and to help fund relevant research; in consultations on 3 April the Dutch Foreign Affairs Council noted that it was important to ensure developing countries could also access the data. An open pledge to in principle share Covid-19 related intellectual property was launched on 7 April. Also in April, the UK’s All-Party Parliamentary Group on Vaccinations for All wrote the prime minister urging him to support the Covid-19 pool as well as take other actions to secure open innovation on Covid-19 technologies.

Effective Use of Compulsory Licences for Export

Countries that lack the manufacturing capacity to produce a particular medicine can benefit from an amendment to the WTO’s TRIPS Agreement, Article 31bis, that allows medicines under a compulsory licence to be made for export (prior to this amendment, a CL had to serve the domestic market). However, 37 high income countries have opted out of using it to import medicines.

On 7 April 2020, Knowledge Ecology International published an open letter calling on these 37 countries to opt back in. In the age of Covid-19, this is critical for several reasons. First, in a public health crisis, even high income countries will need to diversify their supply base to ensure access to all who need medical technologies as urgently as it is needed. Secondly, the manufacture of Active Pharmaceutical Ingredients – what makes a medicine effective – is increasingly outsourced to India and China, even when the final medicine is made elsewhere. This means these high income countries could face challenges in their ability to make a critical component domestically, which is what Article 31bis is designed to address. Third, having more countries willing to import on a CL can contribute to economies of scale that bring down prices for medical technology; thus, even if high income countries do not need to issue such CLs or their own use, doing so can help in countries where an affordable price is necessary to be able to treat their citizens.

Useful Resources on Covid-19

Below are some websites that are providing up-to-date useful information on Covid-19. Click on the logos to access the sites.

World Health Organization:Technical Guidance on Covid-19

Nature Medicine:Latest research and news on Covid-19

The Lancet:Covid-19 Resource Centre

Knowledge Ecology International:Covid-19 Blogs and Research

The Graduate Institute:Data Sources on COVID-19

The Financial Times:Latest Figures on Covid-19

Global Health Law Committee of the ILA: Statement on Covid-19

MedsPal patent status data for Covid-19

VaxMap: Open Source Map of Candidate Vaccines

New York Times: Drug and Treatment Tracker

New York Times: Covid-19 Vaccine Tracker

USP: COVID-19 Vaccine Handling Toolkit