Greetings, and here we are with the European Alliance for Personalised Medicine (EAPM) latest update. Before we get into what’s been going on of late during these testing times (pun intended) here’s a quick reminder that registration is open for our virtual EU Presidency conference, which takes place on Thursday 1 July, writes EAPM Executive Director Dr. Denis Horgan.

Entitled “Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open”, it acts as a bridging event between the EU Presidencies of Portugal and Slovenia.

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. 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

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register, here, and download your agenda here!

Presidency of health

And the upcoming conference ties in very well to the priority of the incoming Slovenian presidency, which is very much a question of health, said the country’s EU Ambassador Iztok Jarc on 10 June, speaking at an event organized by the European Policy Centre. The diplomat described the presidency, which will start at the beginning of July, as a “transitional” one: a bridge to a much-hoped-for return to normality. Jarc said that the hope is to hold an increasing number of diplomatic meetings in person starting in September, particularly high-level ones. 

Health care de-‘Luxe’

Luxembourg is playing host to the bloc’s health ministers on day two of the Employment, Social Policy, Health and Consumer Affairs Council. Up for discussion are the three planks of the health union legislative file: There will be an update on the proposal to amend the regulation establishing the European Centre for Disease Prevention and Control (ECDC), as well as the proposal on serious cross-border threats to health. Meanwhile, the Portuguese Presidency is aiming to reach a Council consensus during the meeting on draft rules to reinforce the role of the European Medicines Agency. 

Better access to medicines is paramount, EU capitals to urge as an outcome of Luxembourg ministers' meeting 

The EU needs to put in more work to ensure access to fairly priced medicines throughout the bloc, according to a draft text authored by EU ambassadors. When it comes to equity and access to health care, the EU could do better. Inequalities around diagnosis and access to drugs and treatments persist; European citizens are not all benefiting equally from universal healthcare services. In addition to these inequalities, one can add another: the discrepancy in detection and diagnosis according to one’s country of residence. Thus, cancer survival rates are often worse for patients in eastern Europe than those being treated in western Europe. Member states do not have the same management tools at their disposal because they do not benefit from the same investment capacities. 

Rather than making sustainable investment in community-based services and facilities and re-establishing equality of access to treatment and the early detection of diseases, the European Commission is moving to a ‘Europe of digital health’ model, relying on ‘virtual’ consultations, based on a telemedicine or telesurgery approach. Ryan Reynolds wants to destigmatize mental health “The pharma industry emerges the winner in this misguided system, but what are the benefits for European public health?” 

Furthermore, between 2000 and 2008, shortages of medicines increased by 20 percent, and - according to the European Commission in April 2020 - these were continuing to increase. In France, for example, supply interruption has trebled in just three years. 

More than half of the medicines in short supply are for cancers, infectious diseases and neurological disorders such as epilepsy and Parkinson’s disease. How can we explain these shortages? The relocation of production sites, particularly of active ingredients, to countries outside Europe, has weakened our healthcare sovereignty. Among the solutions undertaken by the EU, it is essential that the wholesalers provide a reliable, controlled distribution chain for pharmaceutical products to the pharmacies. However, we have seen an increase in alternative and direct channels of distribution between the pharmaceutical industry and pharmacies.

Focus on own failures, not Commission

German MEP Peter Liese of the European People’s Partythinks individuals should focus on their own failures during the pandemic, rather than the Commission’s. Commission Vice President Margaritis Schinas is set to present a Commission document on early lessons learned from the pandemic. Liese pointed to MEP Beata Szydło, former Polish prime minister and vice-chair European Conservatives and Reformists Group, as an example: “She very much criticized the European Commission, but the truth is that the main problem in this advanced purchase agreement with vaccine companies was that some member states, and among them very prominently the Polish government, argued against any contract with BioNTech/Pfizer.” 

EU proposes extending vaccine export scheme to September

The European Commission is proposing to extend its temporary vaccine export authorization program for an extra three months through September, according to EU diplomats.  

The Commission has taken the decision to support various vaccines based on a sound scientific assessment, the technology used, and capacity to supply the whole of the EU. Vaccine development is a complex and lengthy process, which normally takes around 10 years. With the vaccines strategy, the Commission supported efforts and made the development more efficient, resulting in safe and effective vaccines being distributed in the EU by the end of 2020. This achievement required running clinical trials in parallel with investments in production capacity to be able to produce millions of doses of a successful vaccine. Strict and robust authorisation procedures and safety standards are respected at all times.

EU diplomats are expected to vote on the Commission’s proposal this Friday (18 June).

And EU institutions to get cyber bill…

The European Commission is also “preparing a proposal for cybersecurity for the EU institutions, bodies and agencies, which is expected for October this year,” Administration Commissioner Johannes Hahn told MEPs earlier this week. Such a bill would fix a hole in the Commission’s proposed NIS2 Directive for cybersecurity in critical sectors, like health care.

And that is all from EAPM for now – enjoy your start to the week, and don’t forget, now is the time to register for our upcoming conference on 1 July here, and download your agenda here. Have a great week

On 14 June, the presidents of the three EU institutions, the European Parliament, the Council of the EU and the European Commission attended the official signing ceremony for the Regulation on the EU Digital COVID Certificate, marking the end of the legislative process.

On this occasion Presidents David Sassoli and Ursula von der Leyen and Prime Minister António Costa said: “The EU Digital COVID Certificate is a symbol of what Europe stands for. Of a Europe that does not falter when put to the test. A Europe that unites and grows when faced with challenges. Our Union showed again that we work best when we work together. The EU Digital COVID Certificate Regulation was agreed between our institutions in the record time of 62 days. While we worked through the legislative process, we also built the technical backbone of the system, the EU gateway, which is live since 1 June.

"We can be proud of this great achievement. The Europe that we all know and that we all want back is a Europe without barriers. The EU Certificate will again enable citizens to enjoy this most tangible and cherished of EU rights – the right to free movement. Signed into law today, it will enable us to travel more safely this summer. Today we reaffirm together that an open Europe prevails.”

The full statement is available online and you can watch the signing ceremony on EbS.

The EU-Kazakhstan High-Level Platform of dialogue on economic and business matters (Business Platform) held its 7th meeting in Nur-Sultan on 11 June, chaired by Prime Minister Askar Mamin.

The event brought together representatives of business and EU Heads of Mission led by the Ambassador of the EU to the Republic of Kazakhstan, Sven-Olov Carlsson. Visiting EU Special Representative for Central Asia Ambassador Peter Burian joined the event.

The High-level Business Platform complements the technical dialogue between the EU and Kazakhstan within the Enhanced Partnership and Cooperation Agreement, in particular the Cooperation Committee in Trade Configuration, which took place in October 2020.  

The EU has committed to climate neutrality by 2050 and is fully translating the implementation of the Paris Agreement into legislation. Ambitious targets and decisive actions demonstrate that EU is and will remain to be a global leader in the transition to green economy. The climate challenge is inherently global, the EU is only responsibly for approximately 10% of all global Greenhouse Gas emissions. The EU expects from its partners to share a comparable level of ambition to fight climate change and is ready to deepen co-operation with Kazakhstan in this area, including exploring new opportunities for trade and investment.

The recent EU-Kazakhstan Cooperation Council welcomed the progress made in the framework of the Business Platform chaired by the Prime Minister Mamin. The Platform acknowledges the importance of the EU in Kazakhstan's external trade, and discussions on a range of issues contribute to attract more investment in Kazakhstan.

Background Information

The EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (EPCA), fully in force from 1 March 2020, aims at creating a better regulatory environment for businesses in areas such as trade in services, establishment and operation of companies, capital movements, raw materials and energy, intellectual property rights. It is a tool of regulatory convergence between Kazakhstan and the EU, with some “WTO plus” provisions, notably on public procurement. Even in a year as difficult as 2020, the EU has consolidated its position as Kazakhstan’s first trade partner and first foreign investor, and Kazakhstan remains the main trade partner of the EU in Central Asia. Total EU-Kazakhstan trade reached €18.6 billion in 2020, with EU imports worth €12.6bn and EU exports €5.9bn. The EU is by far Kazakhstan's first trading partner overall, representing 41% of total Kazakh exports.