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Update: Co-operation under the microscope in COVID-19 crisis – EAPM EU Presidency Conference report available

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As coronavirus infections soar across the planet, and the death toll rises everywhere, not least in Europe, many are asking why European Union member states were so disconnected from each other strategy-wise, and what the EU can do about improving co-ordination this second time round, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

Well, given that health care is a jealously guarded member state competence, locking-down the answer isn’t easy, and never has been. But that doesn’t help Europe’s citizenry, given that COVID-19 is no respecter of borders and national sovereignty. 

This was one of a myriad discussion items discussed in our recent virtual Presidency Conference entitled ‘Ensuring access to innovation and data-rich biomarker space to speed better quality of care for citizens’. You can read the report here.

As highlighted during the Presidency Conference, there is potential future promise in the European policy context, with the legislative and policy initiatives currently on the EU agenda – most recently – the declaration of Commission President Ursula von der Leyen in favour of European Health Union which was discussed during the conference. 

EAPM has always argued for more EU-wide co-operation and coordination in health care, and the current crisis has only made that need more obvious. 

Indeed, for the best part of a decade,  the Alliance has been calling for policies to tackle diseases of many different types - not least cancer - through new science and personalised healthcare, with the backing of many MEPs.

It is apt that throughout the topic-specific discussions of the Presidency Conference, the broader themes that emerged most insistently were collaboration and communication, since these have been the hallmarks of EAPM’s activity since its initiation. 

EAPM is by definition a collaborative exercise, bringing together the broadest range of stakeholders – as this conference again demonstrated. And communication has been at the heart of EAPM’s activity, since its role is not just as a thinktank for refining ideas, but as a vehicle for transmitting those ideas from the world of healthcare to the broader world of policy, where the decisions are made that ultimately shape the way health is delivered. 

Principal recommendations 

Although there was no formal process of agreeing recommendations at the meeting, the following are among the recurring recommendations from the discussions. 

  • Inequalities in access to testing and treatment across Europe must be addressed

  • Adequate data infrastructure and processing capacity must be available.

  • Real-world evidence must be developed and acceptance criteria agreed with regulators, HTA agencies and payers.

  • Greater flexibility in regulatory requirements is needed to accommodate evaluation of products destined for small populations.

  • Multi-stakeholder collaboration must be developed to agree research priorities, standards and quality assurance of testing, and evaluation criteria for testing and treatments.

  • Trust must be developed among citizens about the security and possible  use of their data.

  • Communication must be developed by healthcare stakeholders to persuade policymakers to effect constructive change.  

The link to the report is available here.

1 million genome meeting on 21 October

Registration is still very much open for the B1MG meeting on 21 October. The aim of the the 1 million Genome Project is to support the connection of national genomics and data infrastructures, co-ordinate the harmonization of the ethical and legal framework for sharing data of high privacy sensitivity, and give practical guidance for the pan-European coordination of implementing genomic technologies in national and European health-care systems. 

Thus, the B1MG is a means to bring the different stakeholders together on Oct 21st so as to act as a catalyst to provide a benchmark approach for alignment of complex, fractionated health-care provisions into health-care systems.

Register here and read the full agenda here.

Have the best week possible, and keep safe.

COVID-19

US supports WTO waiver of Intellectual Property on COVID-19 vaccines

Catherine Feore

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In a surprise announcement by the US Trade Representative Katherine Tai has announced that the US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and will “actively participate in WTO negotiations to make this happen”.

The USTR said that extraordinary times and circumstances called for extraordinary measures. 

In March, European Commission trade spokesperson Miriam Garcia Ferrer told journalists that the current view of the European Union was that the problem of access to vaccines would not be resolved by waiving patent rights. 

Garcia Ferrer said that the real problem lay in insufficient manufacturing capacity to produce the required quantities. The European Commission very much welcomed the statement of WTO Director-General Ngozi Okonjo-Iweala who has said there should be a third way to broaden access to vaccines through facilitating technology transfer within the multilateral rules, to encourage research and innovation while at the same time allowing licensing agreements that helped to scale up manufacturing capacities. 

South African/Indian proposal

WTO members recently debated the proposal submitted by South Africa and India calling for a waiver from certain provisions of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in relation to the “prevention, containment or treatment” of COVID-19. Since its submission, the proposal has received further support from Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and the African Group within the WTO. 

The proponents argue that the waiving of certain obligations under the agreement would facilitate access to affordable medical products and the scaling-up of manufacturing and supply of essential medical products, until widespread vaccination is in place and the majority of the world’s population is immune. 

However, there is a lack of consensus and divergence on what role intellectual property plays in achieving the goal of providing timely and secure access to safe, efficacious and affordable vaccines to all. Proponents argue that existing vaccine manufacturing capacities in the developing world remained unutilized because of IP barriers. Other delegations asked for concrete examples of where IP would pose a barrier that could not be addressed by existing TRIPS flexibilities.

The outgoing chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter of South Africa, said swift action is urgently required to help scale up COVID-19 vaccine production and distribution. She called on members to shift gears and move towards a solution-oriented discussion.

The next regular TRIPS Council meeting is scheduled for 8-9 June, but members agreed to consider additional meetings in April in order to assess potential progress on the IP waiver discussion.

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EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated

EU Reporter Correspondent

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EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

EMA will communicate further when the marketing authorization application for the vaccine has been submitted.

How is the vaccine expected to work?

COVID-19 Vaccine (Vero Cell) Inactivated is expected to prepare the body to defend itself against infection with SARS-CoV-2. The vaccine contains SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. COVID-19 Vaccine (Vero Cell) Inactivated also contains an ‘adjuvant’, a substance that helps strengthen the immune response to the vaccine. 

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it.

What is a rolling review?A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorization. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner.During the rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together experts from across the European medicines regulatory network to advise on the development, authorization and safety monitoring of medicines and vaccines for COVID-19 and facilitate quick and coordinated regulatory action.

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Ukraine's capital Kyiv eases coronavirus restrictions

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Ukraine's capital Kyiv on Saturday (1 May) eased tough restrictions imposed last month to prevent the rapid spread of the new coronavirus.

In early April, Kyiv limited its public transport services, closed schools and kindergartens, theatres and shopping centres, and banned spectators from sporting events.

Starting from Saturday, the capital will allow the operation of transport, cafes and restaurants, although passenger and customer numbers will be restricted. Wearing masks is still mandatory in transport and public places.

Shopping malls and sports clubs were able to reopen on Saturday, while schools and kindergartens will open from 5 May, local authorities said.

Last month, Kyiv recorded some of highest numbers of new infections among Ukrainian regions, but new cases dropped significantly last week.

Ukraine has registered more than 2 million infections and 44,436 deaths since the pandemic started last year.

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