Medicines Law & Policy

What is the ‘know-how gap’ problem and how might it impact scaling up production of Covid-19 related diagnostics, therapies and vaccines?

How the ‘Oxford’ Covid-19 vaccine became the ‘AstraZeneca’ Covid-19 vaccine

Never say never – Why the High Income Countries that opted-out from the Art. 31bis WTO TRIPS system must urgently reconsider their decision

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.