Regulatory Focus™ > News Articles > 2022 > 3 > Euro Roundup: EFPIA urges a rethink of COVID vaccine IP waiver

Posted 24 March 2022 | By Nick Paul Taylor 

Euro Roundup: EFPIA urges a rethink of COVID vaccine IP waiver

2711 EFPIA has called on European governments to readdress a proposal to waive Trade Related Intellectual Property Rights (TRIPS) for COVID-19 vaccines and instead focus on what it perceives to be “the real barriers to global vaccine equity,” in reaction to a compromise reached through talks involving the European Union.
Negotiations between the EU, South Africa, India and the US have resulted in a compromise that the World Trade Organization (WTO) director general Ngozi Okonjo-Iweala called “a major step forward.” The text authorizes some countries to use “patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic.”
The waiver is limited. If enacted, it would apply to developing country WTO members that exported less than 10% of world exports of COVID-19 vaccine doses in 2021. Even so, the proposal goes too far for EFPIA, the European Federation of Pharmaceutical Industries and Associations.
“The draft proposal from the WTO completely undermines the very research-ecosystem that gave us vaccines to protect citizens against COVID-19. It seeks to solve a vaccine production issue that no longer exists, while at the same time, diverts attention and urgently needed effort away from the real barriers to global vaccine equity,” Nathalie Moll, director general at EFPIA, said in a statement.
Moll’s comments echo those made by Steve Bates, CEO of the UK’s BioIndustry Association. Bates argued that the proposal “will have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19,” adding that “it would do nothing to solve the challenges we face in 2022 and make it far harder for small companies pioneering in this space in future.”
An opportunity to change the proposal remains. While WTO’s Okonjo-Iweala spoke of trying to “bring about a full agreement as quickly as possible,” Moll wants governments in Europe and the rest of the world to rethink the proposal. Moll argues that the current bottleneck in vaccine uptake relates to the pace at which lower-middle and low-income countries can administer the available doses.
To support her case, Moll cited a request by the Africa Centres for Disease Control and Prevention (CDC) to pause donations of COVID-19 vaccines until the third or fourth quarter because of the risk logistic challenges and vaccine hesitancy will result in excess supplies that go to waste.
EFPIA Notice, BIA Post
EMA suspends written-only meetings on joint scientific HTA consultations
The European Medicines Agency (EMA) has suspended the written-only meeting format for the current EUnetHTA 21 call for joint scientific consultations.
In updating the guidance a second time, EMA and EUnetHTA have suspended the written-only meeting format. The change follows an earlier decision to create a shortened procedure that offered applicants two options: written-only and face-to-face meetings.
The previous version of the guidance said the written-only procedure allowed the early dialogue working party, now called the Committee for Scientific Consistency and Quality for Joint Scientific Consultation, to “work directly on their recommendations following reception of the Final Briefing package and does not require the applicant to produce written answers to a EUnetHTA List of Issues.”
Streamlining the process reduced the procedure’s timeframe by about a month, as compared to when a face-to-face meeting is needed. While the written-only option now is suspended, EMA and EUnetHTA said “all partners will continue to collaborate and discuss future options for different meeting formats besides the face to face meeting format.”
EMA and the European Network for Health Technology Assessment (EUnetHTA) established the joint call initiative to offer a more efficient procedure while working toward the medium-term goal of finalizing a regular, legally acceptable solution. The open call for applications began in January under the terms of guidance that was updated in March 2021.
EMA Guidance
HPRA chief elected to chair EMA’s management board for 3 years
EMA’s management board has elected the chief executive of the Irish Health Products Regulatory Authority (HPRA) as its chair. Lorraine Nolan takes over from Christa Wirthumer-Hoche, who has completed two three-year stints as chair of the board.
Nolan, who became chief executive of HPRA in 2016, has served as vice chair of the management board since 2019, having first joined three years earlier. She aims to focus on enhancing the partnership between EMA, national agencies and the European Commission to ensure the agency has a “reputation as a modern, progressive and transparent regulator,” according to a statement from EMA.  
The management board elected Nolan for a three-year term at a meeting where it also discussed topics such as the war in Ukraine. EMA told the board it is monitoring possible shortages of medicines in the EU due to the war and proactively assessing “the availability of suitable alternatives in the EU for essential medicines used in the Ukraine to make sure that refugees can continue their treatment uninterrupted, if needed.”
Members of the board also were updated on the launch of the Clinical Trials Information System (CTIS) at the end of January. As of 17 March, EMA had recorded more than 5,000 logins to CTIS. Fourteen sponsors had submitted clinical trial applications using the new system.
EMA Notice, More
EDQM starts gathering feedback on replacing water for injections test
The European Directorate for the Quality of Medicines (EDQM) is running a survey about the proposed replacement of the oxidisable substances test in water for injections. EDQM is considering using the total organic carbon (TOC) test instead.
While EDQM is planning an official consultation phase later, for now it is running a 12-question survey to “make sure that the method and acceptance criteria envisaged in the discussions with partner pharmacopeias would be appropriate and feasible for European manufacturers of sterilized water in containers.”
EDQM said the proposed change has been discussed with the United States Pharmacopeia and Japanese Pharmacopoeia, one of which has already made the switch. The survey asks whether the TOC test is a suitable alternative for the testing of the oxidisable substances, whether respondents have experience of the test and whether they can share data on their use of the test.
EDQM Notice
MHRA approves long-acting AstraZeneca antibody in the prevention of COVID
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized AstraZeneca’s Evusheld to prevent COVID-19 in some patients.
Evusheld is authorized for adults who are unlikely to mount an immune response from COVID-19 vaccination or for whom vaccination is not recommended. Like other COVID-19 antibody treatments,  Evusheld features molecules that are designed to bind to the virus’ spike proteins. The difference is AstraZeneca made changes to extend the half-life of the antibodies. The treatment provides protection against the virus for at least six months. AstraZeneca has expressed hopes that a single dose could protect against COVID-19 for up to 12 months.
MHRA Notice


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