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European Alliance for Personalised Medicine

HERA and Digital Markets Act point way forward for EU health




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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – EAPM held a very succesful conference concerning cancer on 18 September last week, ‘The need for change: Defining the health-care ecosystem to determine value’, with more than 167 delegates in attendance, and a report will be issued next week, writes EAPM Executive Director Denis Horgan.


The EU has created a crisis health authority to deal with future pandemics across the continent. The new Health Emergency preparedness and Response Authority (HERA) is designed to prevent, detect, and rapidly respond to health emergencies. According to the Commission: “HERA will anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities. 

When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the coronavirus response.”

 European Commission President Ursula von der Leyen said: “HERA is another building block of a stronger Health Union and a major step forward for our crisis preparedness. With HERA, we will make sure we have the medical equipment we need to protect our citizens from future health threats. 

HERA will be able to make swift decisions to safeguard supplies. This is what I promised back in 2020, and this is what we deliver.” HERA activities will rely on a budget of €6 billion from the current Multiannual Financial Framework for the period 2022-2027, part of which will come from the NextGenerationEU top-up.

EU innovation fragmentation


EU security research is one of the building blocks of the Security Union. It enables innovation in technologies and knowledge that is crucial for developing capabilities to address today's security challenges, to anticipating tomorrow's threats and contributing to a more competitive European security industry. 

The Commission has decided to initiate a series of actions which will enhance the competitiveness of the European security industry and contribute to meeting the aims of the European security policy. In terms of overcoming the fragmentation of the EU security markets for security technologies, without the involvement, commitment and investment of the EU’s security technology and industrial base, innovative solutions would remain trapped in endless cycles of research and would never be deployed on the field.

Therefore, the consolidation of a single EU security market that increases the competitiveness of the industrial base is a primary objective. This consolidation would not only guarantee the security of supply for strategic technologies, but also safeguard, when required, the strategic autonomy of the EU for technologies, services and systems that are critical to ensuring the protection of EU citizens.

Cancer patients ‘protected by coronavirus vaccines’

Vaccinations against COVID are as effective and safe for people with cancer as for those without cancer, new studies suggest. Cancer patients have an “appropriate, protective immune response” to the jabs without “any more side-effects than the general population,” according to the European Society for Medical Oncology (ESMO). 

The researchers said that the studies show there is a need to promote vaccination in patients with cancer. The studies were carried out because people with cancer were excluded from vaccine clinical trials, due to their weaker immune systems as a result of undergoing anti-cancer treatments. Scientists said that a “multitude of studies” with similar conclusions will be presented today (21 September) at the annual ESMO Congress. 

An analysis of 3,813 participants with a history of past or active cancer in a randomised controlled trial of the BioNTech/Pfizer vaccine shows that the most common side-effects of vaccination were as mild – and occurred at a similar frequency – as within the overall trial population of more than 44,000 people.

Making the Digital Markets Act Fit for the Digital Age 

EU lawmakers are drafting a raft of important new regulations which will impact Europe’s digitising economy for decades to come. One of these proposals is the Digital Markets Act (DMA), expected to be adopted in the next term. 

Thousands of amendments were proposed to this regulation before the summer, many of which have been the result of MEPs trying to outdo each other on how tough they can be on ‘Big Tech’. But after the initial posturing, the hard work now starts on drafting legislation that actually works in practise: a DMA that supports the EU’s ambitions to be fit for the digital age. For Brussels to set the pace for tech regulation around the world will require a cool head, and a thoughtful approach. To be fit for the digital age, the DMA needs to be as dynamic and flexible as the sector it will regulate.

Parliament backs plan to phase out animal testing

On Wednesday (22 September), the European Parliament voted overwhelmingly in favor of a resolution that calls on the European Commission to draw-up an action plan to phase out animal experiments. This is a momentous political victory in a region where recent setbacks have occurred for animals in laboratories. 

Top on the list of setbacks is the revelation that the European Chemical Agency has disregarded the longstanding ban on animal testing for cosmetics by demanding additional animal data for dozens of cosmetic ingredients, which has already killed an estimated 25,000 animals. Humane Society International’s stop-motion short film Save Ralph has helped raise awareness on the fact that the public has been misled about the EU’s cosmetics ban. 

Many more animals may die in painful toxicity tests if the European Commission implements its Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, which as proposed would further cement the EU’s “tick-box” approach to chemical hazard assessment based predominantly on animal testing. 

The Parliament’s resolution correctly points out that non-animal approaches based on human biology are the key to better assess chemical safety. That is one of the reasons why, in the US, the Environmental Protection Agency has committed to phase-out its animal tests requirements by 2035, and the Humane Cosmetics Act is gathering steam in Congress. 

The resolution in favor of an action plan to phase out animal testing was championed by HSI/Europe and other animal protection groups, leading European scientists and companies. The overwhelming cross-party support shown by Members of the European Parliament reflects the growing dismay felt toward recent actions and proposals by the European Chemical Agency and the European Commission.

Happy news to finish: US opens up to fully vaccinated travellers 

The US is easing its coronavirus travel restrictions, reopening to passengers from the UK, EU and other nations. From November, foreign travellers will be allowed to fly into the US if they are fully vaccinated, and undergo testing and contact tracing. The US has had tough restrictions on travel in place since early last year. 

The move answers a major demand from European allies, and means that families and friends separated by the restrictions can be reunited. "It's a happy day - Big Apple, here I come!" French entrepreneur Stephane Le Breton told the Associated Press news agency, as he looked forward to a trip to New York City that had been put on hold because of the restrictions. 

White House COVID-19 co-ordinator Jeff Zients announced the new rules on Monday (20 September), saying: "This is based on individuals rather than a country-based approach, so it's a stronger system." "Most importantly, foreign nationals flying to the US will be required to be fully vaccinated," he said. US restrictions were initially imposed on travellers from China in early 2020, and then extended to other countries.

 The current rules bar entry to most non-US citizens who have been in the UK and a number of other European countries, China, India, South Africa, Iran and Brazil within the last 14 days. Under the new rules, foreign travellers will need to demonstrate proof of vaccination before flying, obtain a negative Covid-19 test result within three days of travelling, and provide their contact information. They will not be required to quarantine. 

That is all from EAPM for now – make sure you stay safe and well and have an excellent weekend, see you next week.

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