Through the legislative labyrinth - Pathways to a healthier EU: Register now – EAPM Autumn Presidency Conference, 10 November

Greetings all! Registration is open for our upcoming Autumn EU Presidency conference which will be a ‘virtual’ event, held online, on Wednesday 10 November, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Please find the link to the agenda here and the link to register here. 

To perfectly match the less-than-perfect times we find ourselves in, the conference is entitled 'Redefining the Unmet needs in Healthcare and the Regulatory Challenge'.  The conference will take place on Wednesday, 10 November 2021 from 08h30 – 15h00 CET.

Despite us not being able to meet face-to-face, events such as this still allow the pulling together of leading experts in the arena of personalised medicine drawn from patient groups, payers, healthcare professionals plus industry, science, academic and research representatives.  A key role of the conference is to bring together experts to agree policies by consensus and take our conclusions to policy makers. 

So, what are among the topics on the table?

The field of regulatory affairs in the European Union is by its very nature a complex one. Perhaps nowhere more complex than in the arena of health – and certainly extremely complicated when it comes to legislating for the exciting advances and growing expectations being brought about by personalised medicine (PM).

The issues and rules surrounding, for example, clinical trials, in-vitro devices and data protection are labyrinthine. Yet all need to be addressed swiftly and effectively if we are to be able to give the right treatment to the right patient at the right time while, at the same time, offering every European equal access to the best treatment available.

There are 27 Member States and the welfare of 450 million citizens to consider, plus so many disciplines, industries and other stakeholders involved that it is often a struggle for legislators to formulate regulations (and even definitions, as we will see) that are satisfactory for all, are up-to-date and progressive, and do the job they are supposed to do. This despite the best efforts from all involved.

Please find the link to the agenda here and the link to register here.

There are certainly ways to make things easier and more efficient. One of the issues noted by the EAPM is that there is insufficient collaboration between all stakeholders currently operating within their own ‘silos’ (a situation that the Alliance is working hard to substantially improve). This is a major problem in many areas of health generally, and PM in particular, covering everything from education to information sharing to the need for one, clear voice to communicate with legislators and much more.

It is also a fact that much legislation tends to be reactive rather than proactive. Again, with better collaboration between all involved stakeholders it will be possible to foresee potential problems that could occur down the line, rather than acting in an ad-hoc manner if and when these problems do occur.

In the hi-tech, fast-moving area of PM it is already, and will become more, vital that stakeholders integrate and collaborate openly and effectively. This should ensure that regulations and legislation covering, for example the new, subgroup clinical trials required to make PM work effectively, the huge practical and ethical issues surrounding Big Data and data protection, and the necessary standards for biobank samples and in-vitro devices are common, understood and enforced across the EU.

Key topics that will be addressed in the conference include:

·       In vitro diagnostics regulation.

·       Pharmaceutical Strategy of the EU

·       Digital Health Europe - Data space for Genomics

·       EU Beating Cancer Plan

The above are just an example of the huge topics, among many up for discussion on the day. So be sure to join us on Wednesday, 10 November. Once again,   please find the link to the agenda here and the link to register here.

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