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 by the Covid-19 pandemic. According to the WHO, 79,515,525 people have had the virus and 1,757,947 people have died of the disease.  At the end of 2020, optimism is cautiously emerging now that Covid-19 vaccines are beginning to be deployed in some parts of the world. But at the same time, mechanisms for rapid production, scale-up and equitable global rollout of the vaccines remain woefully inadequate. As of this writing, high-income countries representing 13% of the world’s population have laid claim on 53% of the vaccine production. Covax, the international procurement mechanism for Covid-19 vaccines intended to serve the developing world, remains seriously underfunded, reports the Associated Press. And the WHO Covid-19 Technology Access Pool, designed to enable knowledge and intellectual property sharing to facilitate production scale-up, is still empty.

Here is the Medicines Law & Policy end of the year blog with its usual highly-biased listing of noteworthy medicines, law and policy events in 2020.

January

4th January: WHO reported on social media that there was a cluster of pneumonia cases, with no deaths, in Wuhan, Hubei province. Here is a good timeline of the early days of the coronavirus outbreak.

8 January: the European Commission published its ‘Report on the protection and enforcement of intellectual property rights in third countries’. The report is the European Union copy-cat version of the US Special 301 list aimed at putting on guard countries deemed to insufficiently protect and enforce intellectual property. The report includes warnings to Argentina, India, Indonesia and Russia for excluding or restricting patentability of secondary uses of medicines. It also lists concerns about ‘ineffective’ or absent data exclusivity in Argentina, Brazil, China, India, Indonesia, Malaysia, Russia, Saudi Arabia, Ukraine and the United Arab Emirates. And it lists Ecuador, India, Indonesia and Turkey for “very broad, vague and arbitrary criteria” for granting compulsory licences. 

January 9 Chinese health authorities and the World Health Organization (WHO) announced the discovery of a novel coronavirus (2019-nCoV), isolated on January 7. The weekend following this announcement the Chinese authorities shared the full sequence of the coronavirus 2019-nCoV genome, providing the basis for diagnostic test and vaccine development.

13 January: The British Medical Journal published a 7-article series on fair pricing of medicines, which presents work done by WHO and its advisory committees of the Fair Pricing Forum. The articles cover topics such as defining the concept of ‘fair pricing’, new business models for research and development, and price transparency. The next meeting of the WHO Fair Pricing Forum will take place in 2021 and will be organised by the WHO together with Argentina.

28 January: The US signed the “new Nafta”, re-babtised “The United-States-Mexico- Canada Agreement (USMCA). Noteworthy about the agreement was the last minute removal of the 10-year market exclusivity for biologic medicines, presumably because Democratic members of Congress who did not want to be tied to a price-hiking provision that would keep cheaper biogeneric versions off the market demanded it.

24 January: Institut Pasteur in France published the sequence of the whole genome of the Coronavirus, 2019-nCov, and submitted the sequences to the Global Initiative on Sharing All Influenza Data (GISAID) platform.

30 January 2020, the WHO Director-General declared the coronavirus outbreak a Public Health Emergency of International Concern (PHEIC), a rallying call for greater global coordination and a more unified response.

Efforts to develop a vaccine for the new disease were getting underway but the top four vaccine producers showed reluctance to get involved, reported Barrons on 31 January. The companies asked for additional incentives before engaging in new vaccine development. In 2019, the global vaccine market was worth US$54 billion. See our commentary on the matter here.

February

11 February: The International Committee on Taxonomy of Viruses (ICTV) announced “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” as the name of the new virus. The disease caused by the virus was named Covid-19.

26 February: Dr Luca Li Bassi, former general director of the Italian medicines agency (AIFA), was awarded the “International  Transparency In Medicines Policies Award 2019” by the Transparency Observatory. He received the honor for chairing the negotiations of the milestone resolution on “Improving the transparency of markets for medicines, vaccines, and other health products” during the 72nd World Health Assembly in 2019.

27 February: WHO published the first digital version of the Model List of Essential Medicines or “e-EML”.

March

March saw some activity related to compulsory licensing to be able to deal with monopolies on Covid-19 technologies. Israel issued a compulsory licence for a drug being tested for efficacy in the treatment of Covid-19 efficacy. Chile’s parliament expressed support for the use of compulsory licensing for Covid-19 vaccines and medicines; in Ecuador, the legislative committee did the same.  On 14 March, Canada adopted a bill to make the issuance of a compulsory licence related to Covid-19 easier and quicker. See our comment on Covid-19 and the comeback of compulsory licensing.

18 March: WHO and others launched the Solidarity Trial, an international clinical trial that aims to generate robust data from around the world to find the most effective treatments for Covid-19.

24 March: Costa Rica proposed that the WHO create a global pool for rights and knowledge over Covid-19 related technologies.

23 March: Gilead applied for seven years of orphan drug exclusivity for its Covid-19 candidate drug remdesivir, a regulatory incentive for the development of medicines for rare diseases. (If only Covid-19 were rare.) The U.S. Food and Drug Administration granted the exclusivity on 23 March, 12 days after the World Health Organization declared the Covid-19 outbreak a pandemic. The move was met with strong criticism by civil society, and on 25 March Gilead rescinded the orphan drug status.

April

16 April: Asset managers, pension funds and insurers called for international co-operation within the pharmaceutical industry to combat coronavirus and asked pharma to let financial considerations take second place in the global challenge of getting the coronavirus under control as quickly as possible.

24 April: Ellen ‘t Hoen and Wilbert Bannenberg received high honours in the Netherlands for their work on access to medicines.

24 April: The WHO announced the establishment of the Access to COVID-19 Tools  Accelerator (ACT-A) for the development of and production of new drugs, vaccines, and tests for Covid-19 and to ensure worldwide access to the products.

May

4 May: European Commission President Ursula von der Leyen hosted the Coronavirus Global Response conference, an online pledging event to accelerate the development, production and equitable access to Covid-19 vaccines, diagnostics and therapeutics. The effort would end up raising close to Euro 16 billion. But the money would be spent without conditions attached to ensure global access to the Covid-29 health innovations.

5 May: Beximco Pharmaceuticals Ltd. (a generic drug manufacturer in Bangladesh, part owned by the Norwegian Central Bank), announced the independent development of a generic version of remdesivir. WTO Members agreed in 2015 that Least Developed Countries, such as Bangladesh, are not required to provide IP rights covering pharmaceutical products until 2033. 

14 May: Medicines Law & Policy together with Health Action International, WEMOS, The Foundation for Pharmaceutical Accountability and Knowledge Ecology International held a webinar entitled: “The WHO Covid-19 Technology Pool: The solution to ensure global access to Covid-19 health technologies” in advance of the World Health Assembly. Over 1000 attendees from all over the world took part in the on-line event or watched the live-stream. A video of the event is here.

14 May: More than 140 world leaders, experts and elders called for guarantees that Covid-19 vaccines, diagnostics, tests and treatments will be provided free of charge to everyone, everywhere, launching the People’s Vaccine campaign.

18-19 May: The World Health Assembly, the WHO’s decision-making body, held virtually for the first time, was dedicated to the Covid-19 outbreak. A resolution coming out of the May meeting called for international cooperation to “contain and control the Covid-19 pandemic and mitigate its impact” as well as for timely and equitable access to the tools needed to diagnose, prevent, and treat Covid-19. It also supports mechanisms to pool patents and technology to aid in this effort.

26 May: EU Trade Commissioner Phil Hogan issued a response to questions from members of the European Parliament about compulsory licensing in Europe, in which he opened the door to opting back into TRIPS Article 31bis mechanism to allow European Union member states to import products produced under a compulsory license in other countries. Knowledge Ecology International (KEI) had the story.

29 May: The World Health Organization established the COVID-19 Technology Access Pool (C-TAP) meant to ensure that knowledge, data and intellectual property are shared so that the diagnostics, therapeutics and vaccines needed to respond to the Covid-19 pandemic become available and accessible to all.

June

29 June: The Dutch competition authority announced it was extending its investigation into Leadiant’s pricing practices for CDCA, an orphan drug the company obtained market exclusivity for despite the fact that it was a known compound with a known off-label use for the treatment of the rare disease CTX. The company’s market exclusivity led to a 500-fold price increase. The Foundation for Pharmaceutical Accountability filed the complaint on 7 September 2018. Perhaps 2021 will see a ruling in this case.

July

1 July, the African Union said it is urgent to address patents and technology barriers for access to future Covid-19 vaccines. In an official communique, the Union called on all countries “to ensure that all relevant technologies, intellectual property, data and knowhow are openly and immediately made available and the rapid scale-up of geographically diverse production to be made possible.”

2 July: The Dutch Commission to study the use of compulsory licensing of medicines imploded after it became apparent that one of the members shared documents with industry lobbyists and invited them to prepare his contributions to the work of the commission. As a result, the report of the commission could not be completed. Instead, the Chairman of the commission submitted his own observations based on the work of the commission which was sent to the Parliament on 2 July. The report provides an assessment framework for the issuance of compulsory licenses for medical products.

7 July: The US announces its plans to leave the World Health Organization.

8 July: The New York Times reported that Mr. Biden (then a presidential candidate)  promised, “absolutely positively,” that as president he would commit to sharing technology and access to a Covid-19 vaccine if the United States develops one first.

10 July: The European Parliament adopted a resolution on the EU’s public health strategy post-Covid-19 which calls on the European Commission and EU member states to “formally support the COVID-19 Technology Access Pool (C-TAP), allowing maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries and citizens”.

30 July: The World Trade Organization Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) Council discussed IP and the public interest in the context of Covid-19. The TRIPS Council held discussions on two Covid-19 related topics. One topic was on IP Measures in the Context of COVID-19 and the other on Intellectual Property and the public interest: Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach To TRIPS Flexibilities. KEI had the story.

August

In August, after Knowledge Ecology International revealed that Moderna had failed to disclose federal funding in mRNA vaccine patent applications, DARPA, one of the US government agencies providing funding for Covid-19 vaccine development, announced an investigation into Moderna.

24 August: The South Centre published a new research paper titled: The TRIPS Agreement Article 73 Security Exceptions and the Covid-19 Pandemic. This paper, authored by Professor Fred Abbott,  discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. His conclusion is ‘yes’.

September

4 September: Moderna lost a key patent challenge related to a key technology used in its Covid-19 vaccine, Nature reported on 4 September. 

9 September: The French Competition Authority fined Roche and Novartis a combined €444 million for conspiring to expand the market of Lucentis, a pricey treatment for age-related macular degeneration, a main cause of loss of eye-sight in industrialised countries by obstructing off-label use of a similar but less expensive medication, Avastin. Roche sells Avastin as a cancer treatment.

22 September: Knowledge Ecology International hosted a side event during the World Intellectual Property Organization (WIPO) General Assembly on “Appraising Progress of WHO’s COVID-19 Technology Access Pool (C-TAP)”. A webcast of the event is available on YouTube. 

October

2 October: South Africa and India submitted a proposal to the WTO TRIPS Council, titled “Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of COVID-19”. The waiver would allow countries to not implement, apply or enforce certain obligations related to COVID-19 products and technologies under Section 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement. Médecins sans frontières (MSF) published a helpful background document. 

5 October: ML&P published the briefing paper titled: How the ‘Oxford’ Covid-19 vaccine became the ‘AstraZeneca’ Covid-19 vaccine that detangles the various roles/relationships between Oxford University & the Jenner Institute, AstraZeneca and several others working on one of the leading candidate vaccines.

7 October: The European Commission struck a €1 billion deal with drug company Gilead to purchase its antiviral remdesivir for the treatment of Covid-19. The British Medical Journal reported that it did so despite the lack of effectiveness. In late September, Gilead had received the interim results from the WHO Solidarity trial showing that remdesivir had little or no effect on hospital patients with Covid-19.

7 October: The Financial Times reports that AstraZeneca retains the right in its contract with producers in developing countries to declare the pandemic over by July 2021 which will allow the company to switch out of ‘not-for-profit’ mode.

8 October: Moderna announced that it would not enforce its Covid-19 vaccine patents while the pandemic continues and that it is willing to license the technology behind the vaccine after the pandemic.

14 October: A Dutch court ordered AstraZeneca to pay damages in a patent evergreening case brought by a health insurance company. We reported details here.

14 October: UNAIDS issued a statement supporting the Covid-19 TRIPS waiver proposal. “We cannot repeat the painful lessons from the early years of the AIDS response, when people in wealthier countries got back to health, while millions of people in developing countries were left behind,” said Winnie Byanyima, Executive Director of UNAIDS.

Also in October, the European Commission published a manifesto for EU Covid-19 Research and Development on its website asking their grantees politely to provide non-exclusive royalty-free licences on the intellectual property resulting from EU-funded research including through existing patent pools.

November

9 November: Pfizer announced to the media efficacy information for its Covid-19 vaccine candidate developed with the German biotech BioNTech: 90% effective at preventing the disease. Scientists welcomed the announcement but also wanted to see the data behind the announcement. 

24 November: The ANTICOV consortium, coordinated by the Drugs for Neglected Diseases initiative (DNDi) launches the largest clinical trial in Africa to treat Covid-19 cases before they become severe.

25 November: European Commission published its new intellectual property action plan and laid out a number of actions relevant for access to medicines and global public health that signalled efforts towards a long-overdue rebalancing of the system.  The plan includes looking  “into ways to incentivise the rapid pooling of critical IP in times of crisis”. The plan also calls on EU countries “to ensure that effective systems for issuing compulsory licenses are in place”. See here for more information.

26 November: Amnesty International calls on WTO member states to support the TRIPS waiver proposal, the Third World Network reported.

30 November, the Medicines Patent Pool (MPP) announced that it had reached a licence agreement with ViiV Healthcare that will help to bring WHO-recommended dolutegravir-based HIV treatments to four upper-middle income countries: Azerbaijan, Belarus, Kazakhstan and Malaysia. To persuade patent holders to include upper-middle income countries in the territory of licence agreements has always been a challenge for the MPP. Unfortunately, the MPP had to agree to keep details related to the royalty rates confidential. The organisation has never before agreed to secret clauses in licence agreements. Hopefully, the ViiV agreement remains a rare exception. 

December

1 December: World AIDS Day (WAD), was a reminder that the work to stem a pandemic that killed 33 million people is not done. At a WHO WAD event several speakers stressed the need to learn from the HIV crisis in addressing the Covid-19 pandemic. Peter Sands, head of The Global Fund, expressed concerns that Covid vaccines may go the same way as ARVs: once high-income countries had access, the focus turned away from the needs of people globally.

2 December: The UK medicines agency approved the first Covid-19 vaccine produced by Pfizer/BionNTech. 

2 December: The Journal Managing IP published its list of 50 most influential people in IP in 2020 and ML&P’s Ellen ‘t Hoen was one of them.

3 December: TRIPS Council special session discussed the Covid-19 TRIPS waiver proposal but did not reach a conclusion. 

9 December: The WTO received a petition signed by over 900.000 people to ensure no IP barriers to the wide availability of Covid-19 vaccines ahead of the TRIPS Council meeting that would consider the proposal to allow countries to forgo certain obligations under TRIPS for the duration of the pandemic.

9 December: The People’s Vaccine campaign warns that most people in developing countries will have to wait until the end of 2021 before they can get a Covid-19 vaccine. This is while rich nations representing just 14 percent of the world’s population have bought up 53 per cent of all the most promising vaccines so far.

10 December: South Africa offered a comprehensive rebuttal to the naysayers to the Covid-19 TRIPS Waiver proposal at the TRIPS Council. Worth a read.

16 and 17 December: The WTO General Council discussed the outcome of the TRIPS Council negotiations on the proposed Covid-19 TRIPS waiver. Devex reports, while wealthy nations secured vaccines for their populations, some several times over, they are not ready to give in on more relaxed enforcement of intellectual property. 

16 December: The WHO posted its report to the Executive Board on “Expanding access to effective treatments for cancer and rare and orphan diseases, including medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies and other health technologies; and improving the transparency of markets for medicines, vaccines, and other health products.” The report is a reminder that also outside Covid-19, health technologies remain out of the hands of many people in developing countries. The report singles out the high price and patent barriers to cell-and gene-based therapies which limits access to people in a few high-income countries. The report will be discussed at the 148th Executive Board of the WHO. 

17 December: In an unplanned transparency service to the public, the Belgian Secretary of State revealed the EU Covid-19 prices per dose on Twitter. Here they are:

• Oxford/AstraZeneca: €1.78
• Johnson & Johnson, $8.50 
• Sanofi/GSK: €7.56
• BioNTech/Pfizer: €12 
• CureVac: €10 
• Moderna: $18

75 kilometers north of Brussels, in the Netherlands, such price information remains a ‘state secret’ which is a few steps up from ‘confidential’ and disclosure can lead to serious repercussions. In response to the news of the price disclosure, the European Commission restated that vaccine prices are confidential. Well, no longer for those of us with a Twitter account.

16 December: Franz-Werner Haas the CEO of Curevac, one of the companies that have a promising Covid-19 vaccine candidate stated in the German newspaper the Stuttgarter Zeiting that time has come to increase international collaboration to advance the development of vaccines and to suspend patents related to the vaccines to help advance the research. 

17 December: the US FDA advisory panel endorsed Moderna’s Covid-19 vaccine clearing the path for FDA emergency use authorisation. 

18 December: the chair of the TRIPS Council reported to the WTO General Council that delegates had not reached an agreement on the proposed Covid-19 TRIPS waiver. The TRIPS Council will therefore continue to discuss the waiver proposal in the New Year. Noteworthy is that the EU expressed support for disseminating the technology and know-how of those who developed the vaccines, through collaboration with other companies that can contribute to the developers’ manufacturing capacity. Which of course was the reason why WHO at the end of May established C-TAP. Our report is here.

21 December: The European Medicines Agency recommended the first Covid-9 vaccine for use in the EU. 

25 December: Pope Francis said in his Christmas message that business leaders must not allow market forces and patent laws to take priority over making Covid-19 vaccines available to all, condemning nationalism and “the virus of radical individualism”.

27 December: Covid-19 vaccinations start throughout the EU.

30 December: UK authorities authorised the Oxford/AstraZeneca Covid-19 vaccine. This vaccine is the lowest priced product and has potential for large scale roll-out, including in the developing world, because of technology transfer agreements with vaccine producers in developing countries including the Serum Institute in India and Fiocruz in Brazil.

31 December: The WHO Covid-19 Technology Access Pool is still empty.  

Happy New Year!