It’s busy, busy, busy for EAPM

Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – EAPM is certainly busy at the moment, preparing for the series of consensus panels next week on 15 March, as well as organizing internal meetings regarding the implementation of the EU Beating Cancer Plan as well as on the regulatory frameworks such as implementation of the In-Vitro Diagnostic Regulations. More on this below, writes EAPM Executive Director Dr. Denis Horgan.

‘Pragmatic’ legislation

EAPM is organizing a series of consensus panels regarding the topic of pharmaceutical legislation on 15 March - the dramatic improvement in the health of the citizens of Europe over the past two centuries has transformed the continent and the lives of the people living in it. But is Europe able to seize the new benefits that science, technology and forward-thinking public-policy decisions could confer on current and future generations of Europeans – or is it losing the will and capacity to grasp the fruits of progress?   To view the agenda click here and to register, click here.

Engagement, cancer EU implementation plan and In-Vitro Diagnostic Regulations

A key part of the EAPM work is to engage with stakeholders from the different specialties as well as patient organizations and to communicate their priorities to  policy makers. Public trust is key here, which EAPM strives for, and EAPM is also hard at work on the implementation of the EU Beating Cancer Plan. It is impossible to overestimate the significance of the past 18 months for the evolution of public awareness of science, as hopes have grown of vaccines and treatments to counter COVID. But this enhanced awareness carries corresponding responsibilities alongside the obvious potential benefits for mustering support for science.

The corresponding leap in citizens' awareness and expectations of the world of science is however presenting a new dilemma: while health policy is encouraging and promoting (and indeed very largely depending on) science to solve the unprecedented challenge that Covid presents, it also has to cater to the importance of bringing society along with developments, to foster understanding and to counter scepticism, suspicion, doubt and even hostility.

The COVID experience is epitomizing a question that has assumed growing importance, especially in Europe, over the past 50 years: taking account of public sentiment as science itself evolves. 

Cancer, cancer, cancer

Wasted opportunities in tackling cancer and in taking advantage of novel healthcare technology are sharply profiled by a European Parliament report. The text recently approved by the special committee on beating cancer (BECA), and was endorsed by the full parliament, could not be more explicit in its draft.

It "deplores the frequent delays to cancer diagnosis related to a lack of information or adherence to cancer screening and detection processes". And it "regrets the inequalities between member states in access to breast cancer screening, which differs at least tenfold across the EU". It suggests that the wider introduction of the personalised approach to cancer – and the dramatic improvements it can make to care – is dependent on a change in mindset over the key issue of detection.

The problem pinpointed in the MEPs' report is emblematic of similar hesitations evident in Europe's response to innovation. Cancer is one of the fields where advances can be made – and have been made – in the application of rapidly developing disciplines, in particular combining genomics, biomarkers, big data and artificial intelligences. MEPs note "huge advances in biology," and the increasing refinement of diagnosis and treatment of numerous different forms of cancer so that treatment can be matched more precisely to the individual patient.

They contend that precision or personalised medicine "is a promising way to improve cancer treatment" through the targeting of mutations, with "treatment choice based on individual tumour biomarkers". The draft report goes on to welcome the promised ‘Cancer Diagnostic and Treatment for All’ initiative under Europe’s Beating Cancer Plan, which aims to improve access to innovative cancer diagnosis and treatment. In particular, it is intended to promote the use of next generation sequencing (NGS) technology for quick and efficient genetic profiles of tumour cells, allowing researchers and clinicians to share cancer profiles. That way they can apply the same or similar diagnostic and therapeutic approaches to patients with comparable cancer profiles.

This will be a focus of series of roundtables that EAPM will be organizing in the next weeks and months focused on the implementation of the EU Beating cancer plan.

WHO advisers unsure on next COVID vaccine composition

Experts advising the World Health Organization on the composition of new COVID-19 vaccines need more evidence on the efficacy of variant-specific jabs in vaccinated and unvaccinated people before making a decision, the group said on 8 March.

The TAG-CO-VAC is reviewing available data to optimize vaccine mediated protection against prevalent circulating variants. The TAG-CO-VAC strongly supports urgent and broad access to current COVID-19 vaccines for primary series and booster doses, particularly for groups at risk of developing severe disease, given that current COVID-19 vaccines continue to provide high levels of protection against severe disease and death, even in the context of the circulation of Omicron. However, to ensure COVID-19 vaccines provide optimal protection into the future, they may need to be updated as new, antigenically distinct variants emerge. The updated vaccines may be monovalent targeting the predominant circulating variant, or multivalent based on different variants.

COVID-19 committee vote

MEPs are voting today (9 March) to mandate the formation of a new, one-year special committee on COVID-19. The committee was called for by the centre-left Socialists and Democrats (S&D) group, and was won as part of negotiations over the European Parliament president position. Parliament insiders say that the S&D is expected to chair the committee and have 8 MEPs on it, while the European People’s Party group will have 10 MEPs, and the Greens 4. Under the draft mandate that will be voted on, the committee will be tasked with gathering lessons learned from the pandemic across a number of areas: including health, the economy, and human rights. 

Europe's bid for AI standard faces long road, EU lawmakers say

Europe's effort to set a standard for artificial intelligence will likely take more than a year, with the debate focusing on whether facial recognition should be banned and who should enforce the rules, two key lawmakers have said. The European Commission last year proposed draft AI rules, seeking to take the lead in a key technology dominated by China and the United States. read more The move came after the COVID-19 pandemic showed the importance of algorithms and internet-connected gadgets in daily life. The EU executive has to negotiate its proposal with the European Parliament and EU countries before it can become legislation. Parliament may agree on a common position in November, kicking off talks with EU countries that could take a year and a half, Dragos Tudorache, one of two lawmakers steering the issue, said.

Commission welcomes EMA's scientific advice on antimicrobials reserved for treating humans

The European Medicines Agency (EMA) has published a crucial scientific advice in the fight against Antimicrobial Resistance (AMR). It contains the experts' recommendations on antimicrobials and groups of antimicrobials, that are to be reserved exclusively for treating infections in people, since the use of antimicrobials in animals contributes to the development of AMR. This science-based analysis, the first of its kind in the world, has systematically assessed all types of antimicrobials. It paves the way for the upcoming adoption of a legislation listing the antimicrobials, which will be reserved for humans. EMA's advice comes at the request of the Commission and has been put together by a panel of leading experts comprising medical doctors, microbiologists and veterinarians. It has already been endorsed by the Agency's Committee for Veterinary Medicinal Products (CVMP) which is composed of representatives from the member states' competent authorities. Discussions with the member states on the timely adoption of the antimicrobials list will start soon.

And that is everything from EAPM for now – remember, you can view the EAPM event on Pharmaceutical Legislation agenda here and to register, click here. Stay safe and well, and enjoy the rest of the week.

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