Greetings health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – it has certainly been busy for EAPM of late, with the focusing on organizing different internal EU expert panels concerning the implementation of the EU Beating Cancer Plan as well as the EU Health Data space and on legislative topics such as the implementation of the in-vitro diagnostic regulation and the upcoming revision of the pharmaceutical legislation, of which there will be more after the Easter break, writes EAPM Executive Director Dr. Denis Horgan.
MEPs raise the curtain on draft AI rules
Two European Parliament co-rapporteurs finalized the Artificial Intelligence (AI) draft report on Monday (11 April), covering where they have found common ground. The most controversial issues have been pushed further down the line.
Liberal Dragoș Tudorache and social-democrat Brando Benifei have been spearheading the discussion on the AI Act for the civil rights and consumer protection committees of the European Parliament, respectively.
“There are things that we agreed already, and they will be in the draft report, and things on which we think that we will agree, but because we haven’t found right now the common denominator, we did not put them in the report,” Tudorache said. “Our approach has been to make this regulation truly human-centric,” Benifei said. “We haven’t agreed on everything, but we have made an important step forward.”
The two lawmakers do not see eye to eye on the conformity assessment, the process that will lead to new AI systems being launched into the market.
The original proposal largely relies on companies conducting their self-assessments, but Benifei considers that might be too risky from a consumer protection and fundamental rights perspective. The draft report is scheduled for discussion in the two parliamentary committees on 11 May. The plan is to have the committees vote on the final text on 26 or 27 October, certified by a plenary vote on 9 November.
‘Right to be forgotten’ on past cancer diagnoses
A past cancer diagnosis can affect access to insurance on the outstanding balance of a mortgage, for example. Belgium’s “right to be forgotten” law allows people cured of cancer, with certain conditions, to access this insurance without paying additional premiums due to their health history. When it comes to certain types of breast cancers, researchers at the Belgian Health Care Knowledge Centre propose shortening the delays in place to accessing such insurance.
Cancer research
Some €405 million of funding for cancer research, as well as renewable energy and climate change, is set to be released under the Marie Skłodowska-Curie Actions (MSCA) programme, the Commission announced on Monday. The money will fund more than 1,500 doctoral candidates in areas such as cancer, Alzheimer’s and glaucoma. A call for applications was first announced in 2021, and the recipients have now been decided. First projects are due to start in August. Meanwhile, the Commission is set to announce another call for applications on 12 May.
Dementia genes
Researchers have identified 42 genes associated with a higher risk of developing Alzheimer’s disease, the most common type of dementia. To do so, scientists compared the genome of more than 100,000 people with Alzheimer’s to that of more than 600,000 people without it.
The scientists found that certain parts of the immune system are involved in developing Alzheimer’s disease. “For example, immune cells in the brain known as microglia are responsible for clearing out damaged tissue, but in some people that may be less efficient which could accelerate the disease,” said Professor Julie Williams, co-author of the study and Centre Director at the UK Dementia Research Institute at Cardiff University and leader of the Genetic and Environmental Risk for Alzheimer’s disease consortium.
Digital Markets Act: Commission welcomes political agreement
The Commission has welcomed the swift political agreement reached yesterday between the European Parliament and EU member states on the Digital Markets Act (DMA). The regulation, agreed in slightly more than a year after it was proposed, is among the first initiatives of its kind to comprehensively regulate the gatekeeper power of the largest digital companies.
A Europe Fit for the Digital Age Executive Vice PresidentMargrethe Vestager, said: “What we want is simple: Fair markets also in digital. We are now taking a huge step forward to get there - that markets are fair, open and contestable. Large gatekeeper platforms have prevented businesses and consumers from the benefits of competitive digital markets.
The gatekeepers will now have to comply with a well-defined set of obligations and prohibitions. This regulation, together with strong competition law enforcement, will bring fairer conditions to consumers and businesses for many digital services across the EU.”
Internal Market Commissioner Thierry Breton said: “This agreement seals the economic leg of our ambitious reorganisation of our digital space in the EU internal market. We will quickly work on designating gatekeepers based on objective criteria. Within six months of being designated, they will have to comply with their new obligations.
Through effective enforcement, the new rules will bring increased contestability and fairer conditions for consumers and business users, which will allow for more innovation and choice in the market. We are serious about this common endeavour: no company in the world can turn a blind eye to the prospect of a fine of up to 20% of their global turnover if they repeatedly break the rules.”
Organ donations – worrying drop in Germany
The German Foundation for Organ Transplantation is “deeply concerned” about a significant drop in organ donations this year. The foundation said that the drop was unexpected and comes despite long waiting lists of about 8,500 people. One of the reasons for the drop is staff shortages in ICUs, as well as patients presenting for an organ donation and being infected with coronavirus, despite not having symptoms.
Council approves rules on medicine supply to Northern Ireland
The Council of the EU has adopted legislation that allows for the stable supply of medicines from Britain to Northern Ireland, it has announced.
This is the final step before the rules can be published in the EU’s Official Journal and become law. The legislation aims to safeguard the supply of medicines to Northern Ireland by exempting companies from EU rules that would otherwise make it too burdensome for them to market their products in the country.
The European Parliament gave its nod to the rules last week after the Commission presented a proposal on the topic in December.
WHO greenlights single-dose HPV vaccine schedule
A single dose of the Human Papillomavirus (HPV) vaccine offers comparable protection to the current two dose schedule, according to a review from the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) released this week.
The 4-7 April convening of the WHO Strategic Advisory Group of Experts on Immunization (SAGE) evaluated the evidence that has been emerging over past years that single-dose schedules provide comparable efficacy to the two or three-dose regimens.
SAGE’s review concluded that a single-dose Human Papillomavirus (HPV)vaccine delivers solid protection against HPV, the virus that causes cervical cancer, that is comparable to 2-dose schedules. This could be a game-changer for the prevention of the disease; seeing more doses of the life-saving jab reach more girls.
Often referred to as the ‘silent killer’ and almost entirely preventable, cervical cancer is a disease of inequity of access; the new SAGE recommendation is underpinned by concerns over the slow introduction of the HPV vaccine into immunization programs and overall low population coverage, especially in poorer countries.
More than 95% of cervical cancer is caused by sexually transmitted HPV, which is the fourth most common type of cancer in women globally with 90% of these women living in low- and middle-income countries.
And that is everything from EAPM for now – we would just like to thank our partners and associates for all their efforts over recent weeks, and to wish you a very happy Easter. Stay safe and well.
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