Welcome to the annual end of the year blog, our highly biased overview of noteworthy events in the field of medicines law and policy. It will not come as a surprise that 2021 was also dominated by the Covid-19 pandemic and the severe inequity in access to pandemic countermeasures, in particular Covid-19 vaccines and tests. While rich countries are rolling out child vaccination and booster campaigns, in low-income nations vaccination rates hover around 7%. Also the manufacturing know-how remains firmly in the hands of multinational vaccine corporations. Inequity in access to Covid-19 counter-measures reflects the concentration of manufacturing capacity in the hands of too few companies. None of the vaccine manufacturers is working with the WHO Covid-19 Technology Access Pool (C-TAP). The TRIPS Waiver, proposed in October 2020 by India and South Africa to help overcome hurdles of intellectual property protection to the scale-up of production, remains in limbo.
While Covid-19 dominated global medicines law and policy developments, there are of course other issues that need attention. The high price of medicines, in particular those needed to treat cancer, is one such area as is evidenced by the WHO Essential Medicines Committee’s comments when it considered applications for essential but highly-priced cancer medicines for inclusion in the list.
At the World Health Organization’s Executive Board meeting 19-26 January, WHO Director-General Dr Tedros raised the alarm about the lack of equity in the distribution of Covid-19 vaccines. Quoting disturbing statistics he said: “More than 39 million doses of vaccine have now been administered in at least 49 higher-income countries. Just 25 doses have been given in one lowest-income country. Not 25 million; not 25 thousand; just 25.” He added: “I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”
After the new Biden-Harris administration was sworn in on 20 January 2021, the US re-joined the WHO. Dr Fauci represented the US at the WHO Executive Board in January and outlined the country’s priorities for global health.
On 15 February, Ngozi Okonjo-Iweala was appointed director-general of the World Trade Organization. She is the first woman and the first African to lead the organisation. Having been the chair of the GAVI board – a public-private partnership for vaccine access and the group running the Covax facility, which was created for facilitating equitable Covid-19 vaccine distribution – it did not come as a surprise that she made ending the Covid-19 pandemic and equitable access to affordable vaccines her priorities. In her first speech to the WTO Members she said, ”For the global economy to return to sustained growth, the global community will need to get a tight grip on the pandemic by intensifying cooperation to make equitable and affordable access to vaccines, therapeutics, and diagnostics a key plank of the recovery.” She further urged Members to refrain from vaccine nationalism and protectionism and said that it was important to “intensify cooperation on promising new vaccines, therapeutics, and diagnostics.” She added, “There should be a “third way” to broaden access through facilitating technology transfer within the framework of multilateral rules, so as to encourage research and innovation while at the same time allowing licensing agreements that help scale up manufacturing of medical products.”
Also in February, the European Commission published an emergency plan which was labelled the “vanguard for the European Health Emergency Preparedness and Response Authority (HERA)”. HERA was announced in November 2020. The Commission’s plan includes the following elements: Rapid detection of variants; (2) Swift adaptation of vaccines; (3) Setting up a European Clinical Trials Network; (4) Fast-tracking regulatory approval of updated vaccines and new or repurposed manufacturing infrastructures; and 5) Enable upscaling of production of existing, adapted or novel COVID-19 vaccines.
The Canadian pharma company, Biolyse decided to apply for compulsory licences to be able to produce and distribute Covid-19 vaccines in developing countries. It did so after it failed to obtain voluntary licences from AstraZeneca and Johnson & Johnson.
The Dutch National Health Care Institute (responsible for advising the government about the coverage of health care interventions) prevented the drug company Lupin from exploiting its dominant position in the market after it obtained an orphan drug designation for the use of mexiletine for the treatment of non-dystrophic myotonia. The company had increased the price 100 fold. The Dutch institute rejected it for inclusion in the basic care package. Companies that abuse orphan drug regulation to obtain market monopolies primarily to exploit them to demand high prices are often called ‘medicines pirates’.
India banned exports of Covid-19 vaccines in a drive to expand vaccination of its own population during a severe second Covid-19 wave. The ban affected Covax’s distribution plans, which, at the time, was largely dependent on the Serum Institute India’s (SII) production of Covishield for the supply of vaccines to low-income countries. The export ban was lifted in October 2021 and SII resumed supply to Covax in November 2021.
The WHO announced the establishment of technology transfer hubs to expand mRNA vaccine production capacity in low and middle-income countries. The WHO calls for owners of technology and intellectual property (IP) to contribute to the initiative. For the time being, the WHO moves ahead without the collaboration of the corporations that hold the technology and accompanying IP of these products.
On May 5th, the US took everyone by surprise by expressing support for a temporary TRIPS Waiver for Covid-19 vaccines, which would exclude therapeutics or other tools such as diagnostics. The EU remains the firmest opponent to any TRIPS rules waiver.
On 12 May, the Independent Panel for Pandemic Preparedness & response (IPPPR) presented its report with recommendations for action to curb the Covid-19 pandemic and to prevent any future outbreaks from turning into catastrophes. The Medicines Law & Policy team wrote one of the background documents about the legal challenges of scaling up vaccine production capacity.
In June the WHO Expert Committee on the Selection and Use of Essential Medicines met for two weeks to consider applications for 40 new medicines and 16 new indications for inclusion in the Model List of Essential Medicines. Updated roughly every two years, these lists guide countries around the world in selecting the highest priority medicines that should be available and affordable for their populations and thus represent critical expert guidance for health systems serving an estimated 5 billion people globally.
The Drugs for Neglected Diseases Initiative (DNDi) announced that the Malaysian medicines regulatory agency had granted conditional registration for a hepatitis C (HCV) treatment developed by a partnership of the Malaysian Ministry of Health, the DNDi, the Egyptian pharmaceutical company Pharco, Malaysian pharmaceutical company Pharmaniaga Berhad, and Médecins Sans Frontières/Doctors Without Borders (MSF). This signals the first HCV drug developed through South-South collaboration and with funding and clinical support from non-profit organizations. The partnership decided to develop the HCV treatment to respond to the lack of access to affordable direct-acting antivirals (DAAs), a newer generation of powerful HCV treatments that can cure patients in three to six months.
The Left in the European Parliament published the study “Advanced Purchase Agreements for Covid-19 vaccines. Analysis and Comments” carried out by researchers of Medicines Law & Policy. The report examines the texts of several Advanced Purchase Agreements the European Commission entered into with pharmaceutical companies for the purchase of Covid vaccines, to determine if the terms and conditions of the contracts promote vaccines as global public goods, which was a stated objective of the European Commission. A stated objective is all it turned out to be. As far as possible to determine – after all, the published agreements are heavily redacted – the APAs did not reflect this objective.
On 19 July, the Dutch competition authority, Netherlands Authority for Consumers and Markets (ACM), imposed a fine of nearly 20 million Euro on the manufacturer Leadiant for abuse of its dominant position in the market by charging an excessive price for the prescription medicine CDCA. CDCA is an orphan medicine used to treat a rare metabolic disease in children. The company, after securing a monopoly in the market, raised the price of the product 500 fold. The case was brought by the Foundation for Pharmaceutical Accountability, a Dutch NGO working to encourage a more responsible and human rights oriented pharma industry.
BioNTech, which holds the original technology for the Pfizer/BioNTech mRNA Covid-19vaccine, began exploring the possibility of establishing Covid-19 vaccine manufacturing capabilities in Rwanda and Senegal.
Reuters reported that Cuba will provide Covid-19 vaccines the country developed as well as the know-how to produce them to Vietnam.
The World Health Organization Europe published a Health Evidence Network synthesis report entitled “What is the evidence on legal measures to improve the transparency of markets for medicines, vaccines and other health products (World Health Assembly resolution WHA72.8)?” carried out by Medicines Law & Policy researchers. The report was an examination of what actions governments had taken following a 2019 World Health Assembly resolution 72.8 to improve transparency in medicines markets, including on research and development costs. The report found several initiatives that can support greater transparency of pharmaceutical price components, ranging from legal reform (e.g. requiring manufacturers to disclose the public subsidies it received towards the cost of R&D for medicines that will be reimbursed in France and Italy), to government websites disclosing rebates (e.g. Switzerland), to private clearinghouses where buyers share confidential (net) price information (e.g. Dutch Hospital Benchmark initiative).
The DNDi announced that the COVID Moonshot, a non-profit, open-science consortium of scientists from around the world dedicated to the discovery of globally affordable and easily-manufactured antiviral drugs against COVID-19 and future viral pandemics, received key funding of £8 million from the Wellcome Trust, on behalf of the Covid-19 Therapeutics Accelerator.
The European Commission settled its dispute with AstraZeneca over vaccine supply issues in the European Union.
The WHO published the 22nd Model List of Essential Medicines (EML) and Essential Medicines for Children (EMLc) drawn up by the Expert Committee on the Selection and Use of Essential Medicines. Overall, 20 new medicines were added to the EML and 17 to the EMLc this year. Diabetes was a particular focus, in the wake of insulin shortages and backbreaking prices when it is available. Several new treatments for cancers were added to the lists. The unsustainable prices of important medicines – both promising new ones as well as older treatments – was a key concern of the Expert Committee. The “trend of continually increasing prices of new medicines over time, particularly in the areas of cancer, autoimmune diseases, infectious diseases and rare diseases” has delayed or prevented the addition of potentially helpful medicines to the Model Lists as they cost “multiples of median annual household incomes making them unaffordable even in high-income countries,” the Committee noted. It recommended establishing a standing EML Working Group to support the Expert Committee to provide advice to WHO on policies and rules to make high priced essential medicines more affordable and accessible and a larger role for the Medicines Patent Pool.
The Medicines Patent Pool, on 27 October announced its first agreement on a Covid-19 therapy with Merck Sharp & Dohme (MSD) for molnupiravir. A second agreement for a Covid therapeutic followed in November when the MPP signed a licence with Pfizer for its oral antiviral treatment Paxlovid.
Cameroon’s ratification on 5 October of the 2019 treaty to set up the African Medicines Agency has triggered a 30 day period during which the African Union must start operating the Agency, the Lancet reported. The AMA will be fully operational by 2022. This is an important step forward in regional cooperation on medicines registration in Africa.
Besides the EU’s external trade and aid agendas, the EU’s internal medicines regulation also has global ‘side effects’ on access to medicines in low- and middle-income countries, according to new research published in the Lancet Regional Health – Europe, and led by a Medicines Law & Policy researcher. These findings point to the need for principles for global equitable access to medicines to guide EU pharma policy, especially now that the European Commission is solidifying and expanding its work on medicines.
Medicines Law & Policy, Knowledge Ecology International and the Menorca School of Public Health hosted an expert working group to discuss how IP issues and sharing of know-how and technology should be addressed in a pandemic treaty. In preparation for the meeting ML&P published a background document on Lessons for a pandemic preparedness treaty from previous successes and failures with treaty-based technology transfer.
On the 14th of November, the WTO Doha Declaration on the TRIPS Agreement and Public Health had its 20th anniversary.
On 23 November, the Covid-19 Technology Access Pool (C-TAP) announced its first licence on a diagnostic technology that detects anti-SARS-CoV-2 antibodies and measures adaptive immune responses that can indicate a previous or recent infection. The technology was licensed from the Spanish Research Institute (CSIC), which had originally announced its intention to do so in May 2021 at a one-year anniversary event for C-TAP. “Just like the virus, science knows no frontiers,” said Spain’s minister for science and technology, Diana Morant, at the licence signing ceremony on 23 November.
The Medicines Patent Pool (MPP) revealed it is in talks with Moderna for licensing of its Covid-19 vaccine IP to enable the mRNA technology transfer hub the MPP is involved in. The mRNA technology transfer hub is established with the support of the Government of South Africa, the African CDC and the WHO.
The Israel Competition Authority announced it has opened enforcement proceedings and that it is considering a financial sanction of €2.2 million against MBI Pharma, and 2 fines of €172,000 to its directors for abuse of its monopoly position to charge unjust prices for CDCA. According to Lexology this is the first time the Israel Competition Authority has opened enforcement proceedings against a monopolist for charging an unfairly high price. In June of this year, the Dutch competition authority had fined Leadiant, which markets CDCA in the Netherlands for the same reason. MBI Pharma markets CDCA Leadiant in Israel. Similar competition cases against Laediant are pending in Belgium, Italy and Spain.
The World Trade Organization’s 12th Ministerial Conference (MC12), which was scheduled to take place from 30 November to 3 December was cancelled because of concerns about the new Covid-19 variant omicron. MC12 would have coincided with the World Health Assembly which led us to ponder the question ‘what if the health and trade ministers would meet in the same room’?
On Friday, December 3, 2021, KEI requested an open public interest licence to allow the exploitation of PF-07321332 (marketed in combination with ritonavir under the brand Paxlovid) in the Dominican Republic.
The Special Session of the World Health Assembly decided to commence negotiations for a new legal instrument for pandemic preparedness.
The WHO listed the 9th Covid-19 vaccine for emergency use. See here for the complete WHO Emergency Use Listing of Covid-19 vaccines.
On 28 December the Texas Children’s Hospital and Baylor College of Medicine announced that their protein sub-unit Covid-19 vaccine Corbevax, whose technology was created and engineered at its Center for Vaccine Development (CVD), had received Emergency Use Authorization from the Drugs Controller General of India to launch in India with other underserved countries to follow. According to the Washington Post, “Unlike the vaccines of big-name manufacturers such as Pfizer-BioNTech and Moderna, the Texas Children’s Hospital vaccine, which is called Corbevax, is being shared patent-free.” The developers Dr Peter Hotez and Dr Maria Elena Bottazzi are also in talks with the World Health Organization to see how they can share the vaccine globally. They are taking their ambition to develop and offer a People’s Vaccine seriously.
On 29 December the Cuban biotechnology organisation BioCubaFarma announced that it had obtained emergency use authorisation in Mexico for its Covid-19 vaccine Soberana. The Soberana 02 (FINLAY-FR-2) Covid-19 vaccine is a conjugate vaccine in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid. In September, the Lancet published this study showing efficacy and safety.
Looking towards 2022
As the end of 2021 is getting near, there is still no progress in talks on a WTO TRIPS waiver nor are there other new solutions on the horizon at the WTO to ensure that IP and know-how related to Covid-19 technologies is shared for the wider public good. WTO Members will continue their discussions on IP and the pandemic.
In the meantime, the Omicron variant is gaining ground which makes the need for rapid and expanded vaccinations worldwide only stronger. For some, this will be the first shot; for others, their second or third shot. The inequity in access remains.
Covid-19 vaccines have become a huge commercial success for the pharmaceutical industry in 2021. For 2022, projections stand at US$124 billion in Covid-19 vaccine sales of which US$93.2 billion is in sales for Pfizer and Moderna alone.
For anyone looking for holiday reading recommendations, we suggest downloading the new South Centre / Max Plank Institute open access publication “Access to Medicines and Vaccines. Implementing Flexibilities Under Intellectual Property Law”.
Happy New Year!
This blog was updated on 31 December with some Covid-19 vaccine developments that took place in late December.