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

Covid shows the world it needs new rules to deal with pandemics

The World Health Assembly, the World Health Organization (WHO)'s annual decision-making meeting, begins next week and will run from 24 May - 1 June....

Independent Panel for Pandemic Preparedness and Response: Uneven access to vaccination is pre-eminent problem

The Independent Panel for Pandemic Preparedness and Response (IPPPR) today released its findings in a report titled “Covid-19: Make it the last pandemic,” laying...

BMJ Commentary: Overriding drug and medical technology patents for pandemic recovery: a legitimate move...

Interest in the use of compulsory licensing is making a comeback in high-income countries in response to concerns about access to Covid-19 vaccines and...

Ensuring that intellectual property rights aren’t a barrier to scaling-up: the remarkable example of...

This week various international bodies are tackling different challenges in meeting the urgent problem of scaling-up manufacture of and access to vaccines for Covid-19....

We need a Global Vaccines Taskforce, not just a British or European one

The European Commission has been heavily criticised for its performance over Covid-19 vaccine supply to European Union Member States. Despite the urgency of the...

The European Commission says Covid-19 vaccines should be global public goods, but do their...

By Ellen 't Hoen & Pascale Boulet The European Commission has entered into advance purchase agreements (APAs) for Covid-19 vaccines with six pharmaceutical companies and is...

The elephant in the room at the WHO Executive Board

The World Health Organization (WHO) Director-General, Dr Tedros Adhanom Ghebreyesus spoke harshly about the lack of Covid-19 vaccines in developing countries at the opening of...

Wrapping up 2020 with some noteworthy medicines, law and policy events

Wrapping up the year 2020 can’t happen soon enough. This year, one way or the other, most people on the planet have been affected...

Decision on intellectual property waiver over Covid technology on hold till 2021; what are...

Note: This article was edited on 19 December to include a statement from the EU supporting sharing of intellectual property, technology, and know-how transfer. The...

What is the ‘know-how gap’ problem and how might it impact scaling up production...

This entire article is also available as a PDF by clicking here. 1. Introduction. How relevant are concerns about intellectual property rights causing problems for...

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.

Featured

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

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May 2021:

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March 2021:

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February 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