Good morning, health colleagues, and a warm welcome to the European Alliance for Personalised Medicine (EAPM) update. We have exciting news this morning as an upcoming 2nd Bridging Presidency conference during the Slovenian Presidency of the EU will take place on 1 July, writes EAPM Executive Director Dr. Denis Horgan.
Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open
The theme of EAPM’s 2nd Bridging Presidency conference, which will be held on Thursday, 1 July, during the auspices of the Slovenia Presidency of the EU, will be ‘Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care’.
The conference is divided into five sessions which cover the follows areas:
- Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust
- Session 2: Beating Prostate Cancer and Lung Cancer – The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening
- Session 3: Health Literacy – Understanding Ownership and Privacy of Genetic Data
- Session 4: Securing patient Access to Advanced Molecular Diagnostics
So, what are among the topics on the table?
The current COVID-19 crisis has thrown many European, and indeed global, healthcare issues into sharp relief. It has also raised important questions, not necessarily new ones, but ones that have shifted more into focus during the pandemic.
One such question is whether the EU should have a bigger role in public health – and particularly in the provision of health technology. This, of course, would impinge upon the closely guarded member state competence in healthcare so, if this were to happen, how would that be?
Another question is how can the now very evident gaps be bridged in order to better protect Europe’s health ahead of another crisis and how do we identify potential patients? What are the priorities? Should the EU develop Lung and Prostate Cancer Screening Guidelines? The broader question, as mentioned above, is whether it’s time to give the EU a bigger role in Europe’s health protection.
Meanwhile, at the heart of personalised medicine, is the hugely expanding use of health data. This is a sensitive topic. There’s certainly a need for the health-science community to talk more openly about using personal health data in research to enhance human health and eradicate diseases such as cancer and the public has to be at the centre of any and all discussion.
Many national and international initiatives rely on comprehensive data analytics to drive evidence-based solutions to improve health outcomes.
Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field. We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below.
In other news…
500million BioNTech/Pfizer doses set for global distribution from US
The Biden administration plans to purchase 500 million doses of Pfizer coronavirus vaccine to distribute to other nations, significantly adding to its ongoing efforts to inoculate populations around the world, according to three people familiar with the plans. The move by the U.S. government could lead to 200 million Pfizer doses being sent worldwide this year, followed by another 300 million across the first half of 2022, according to the individuals familiar with the plan. President Joe Biden will announce the plan ahead of the G-7 meeting in the United Kingdom.
Pfizer and its development partner BioNTech have boasted in recent weeks that they are vastly expanding manufacturing capabilities and expect to deliver billions of doses within the next few years.
EU Digital COVID Certificate
MEPs see the EU Digital COVID Certificate as a tool to restore freedom and urge EU countries to implement it by 1 July. The certificate aims to enable easier and safer travel by proving someone has been vaccinated, had a negative COVID test or recovered from the disease. The infrastructure for it is in place and 23 countries are technically ready, with nine already issuing and verifying at least one type of certificate.
In a plenary debate on 8 June, Juan Fernando López Aguilar (S&D, Spain), the lead MEP regarding the certificate, said that freedom of movement is highly prized by EU citizens and that the negotiations on the COVID Certificate “have been completed in record time”.
“We want to send out the message to European citizens that we are doing everything we can to restore freedom of movement.”
Justice Commissioner Didier Reynders said: “The certificate, which will be free of charge, will be issued by all member states and will have to be accepted across Europe. It will contribute to a gradual lifting of restrictions.” Member states have to apply the rules The COVID certificate is “the first step towards getting rid of restrictions and that is good news for many people in Europe – people who travel for work, families that live in border areas, and for tourism,” said MEP Birgit Sippel (S&D, Germany).
She said it is now up to EU countries to harmonise the rules on travel. “All citizens in the European Union rightfully expect to be able to use this system by the start of summer and member states must deliver,” said Jeroen Lenaers (EPP, the Netherlands). He said that this means not only the technical implementation of the certificate, but much more: “European citizens want to finally have some co-ordination and predictability on our internal borders.”
Plenary vote on waiver
MEPs will today (10 June) vote on a resolution on the TRIPS waiver discussions — the European Parliament endorsed a resolution on Wednesday (9 June) calling for a temporary waiver of COVID-19 vaccine patents, while the Commission remained firm in its opposition to such measures and said it has different plans to speed up the global vaccine rollout.
The Parliament voted in support of waiving COVID-19 vaccine intellectual property (IP) rights with 355 to 263 and 71 abstentions. The vote came after a debate on whether the EU should join other countries such as South Africa and India in demanding a waiver of IP rights in the context of the World Trade Organisation (WTO). MEPs were largely split: while some called on the Commission to support the waiver, others, particularly from the centre-right European People’s Party (EPP), argued that this would not accelerate the provision of vaccines and would harm innovation.
Lawmakers in the European Parliament’s trade committee expressed their pro-waiver position on 25 May, after adopting a report on the trade-related aspects and implications of COVID-19. The report urged the EU to engage in constructive talks with the WTO for a temporary waiver from the IPR protection on COVID-19 vaccines, to ensure that countries do not face retaliation over COVID-19-related patent infringements. According to the Greens leader, one tool to bring this forward and boost global vaccine production is the temporary waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as compulsory licensing and knowledge sharing for countries of the south of the world.