Connect with us

European Alliance for Personalised Medicine

Health academic publications on pharma legislation and unmet medical need push parameters of discussions forward

SHARE:

Published

on

We use your sign-up to provide content in ways you've consented to and to improve our understanding of you. You can unsubscribe at any time.

Greetings health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update. With the race on to get through different legislative dossiers as we reach mid-term of this legislative period, as mentioned in different communications over the last weeks, the European Alliance for Personalised Medicine (EAPM) has been working with EAPM experts and colleagues to develop different publications, writes EAPM Executive Director Dr. Denis Horgan.

The first of this series, Towards Better Pharmaceutical Provision in Europe—Who Decides the Future?, please click HERE to read the article, deals with the revision of the pharmaceutical legislation as well as the complicated discussion of unmet medical needs. This topic will form the basis of EAPM's engagement with the European Commission, European Parliament and Council. The second publication is entitled Meeting the Need for a Discussion of Unmet Medical Needs, click HERE to read the article. 

These publications are based on a series of day-long panel discussions in March, April and May among representatives of key stakeholder groups to tackle these topics.  

This included public health decision makers, representatives from the European Commission, Members of the Parliament, patient organisations, Health Technology Assessment (HTA) representatives, and umbrella organisations representing interest groups and associations actively engaged in the field explored the common challenges and common frameworks to best support improving the quality of life of citizens across Europe, with the best possible alignment of national and EU level approaches to health care provision. 

The first paper provides an overview of the discussions, highlighting the questions that are still open as well as the areas of consensus, including some of the tentative pathways that were suggested for further exploration in search of solutions.  

In the run-up to the legislative process that is scheduled to begin by the end of 2022, discussions are focusing on how Europe can best promote the huge potential benefits of new science and technology within a regulatory framework that, according to the European Commission’s 2019 ‘pharmaceutical strategy’, envisages protecting both the interests of Europe’s patients and the sustainability of the member states’ public health systems—a dual objective that is itself not without controversy, as detailed below. 

The questions are multiple: What frameworks can foster innovation, including in areas of unmet medical need (UMN)? What mechanisms can help ensure access to medicines? How can security of supply be improved? How should public policy adapt to new scientific and technological developments? Furthermore, how to bring greater efficiency into health care provision? The answers are more elusive. There is wide agreement on the objective of better, more equitable, more reliable, and more efficient health care.

Advertisement

How can patients’ perspectives, preferences, and insights be integrated into such a list? Is the EU creating standards that will limit regulatory incentives only to therapeutic areas that feature on a list? This is unlikely to ease the current relative decline in EU global competitiveness, which is one of the stated goals of the EU pharmaceutical strategy. On the most recent figures, 20% of innovative medicines come from the EU, compared to 50% from the US—a reversal of the situation of 25 years ago. 

The EU has fallen far behind, while competition from Asia and in particular China is growing. European patients and Europe’s economy suffer accordingly. So as the Commission is poised to make the innovation process in the EU even more challenging, and possibly less rewarding, for pharmaceutical developers to file their products in the EU, it is appropriate to reflect on measures that could better ensure an EU regulatory system that remains attractive for the development of innovative treatments.

Furthermore, how can the EU bring greater efficiency into health care provision? 

The answers are more elusive. There is wide agreement on the objective of better, more equitable, more reliable, and more efficient health care. However, at the same time there are sharply differing shades of opinion on how this should be done. Furthermore, the discussions are now conditioned by stark new circumstances, including COVID-19’s demonstration of the continuing vulnerability of global populations to pandemic infection, and the Ukraine conflict’s demonstration of the fragility of the global political order—and the concomitant and consequent disruption these events have imposed on health services and health. 

The second publication, Meeting the Need for a Discussion of Unmet Medical Needs, click HERE to read the article, follows in the wake of Europe and the world’s battle against COVID, as the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling “unmet medical need” (UMN). 

This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective.

Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. 

It cautions that such an approach presumes that “unmet need” can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable—the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected. 

Coincidentally, this legislative review is taking place against the background of the COVID outbreak, lending particular significance to the topic of UMN—with the surprise element in the speed, scope and scale of that pandemic still resonating across Europe and around the world. The recent declaration of monkeypox as a major health threat only adds to the importance of the debate.

EAPM is happy to have these publications accepted in academic journals, and is very satisfied with the consensus driven nature of the pieces and diverse range of co-authors that participated.

EAPM has ensured that the publications are open access, and more information will follow in the next few weeks. EAPM will plan an event in October to discuss these publications with the powers that be in the European parliament. 

Once again, the articles are available here: 

  • Towards Better Pharmaceutical Provision in Europe—Who Decides the Future?, please click HERE.
  • Meeting the Need for a Discussion of Unmet Medical Needs, click HERE to read the article. 

And that is everything from EAPM for now. Stay safe and well, and enjoy the last days of August.

Share this article:

EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.

Trending