Connect with us

EU

#EEAPM - Busy times ahead for the EU, while Health Committee rolls out its positions

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.

Next year promises to be a ‘biggie’, even by the standards of the European Union, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Not only is the UK set to leave the bloc at the end of March 2019, but there is also the small matter of the European Parliament elections at the end of May and a new Commission in the wake of all that.

Oh, and we may see the scrapping of mandatory daylight saving time and all the palaver of remembering to change the clocks in spring and autumn, with the Commission suggesting that member states should make their own minds up.  That could lead to a whole heap of confusion of course, but certainly European Transport Commissioner Violeta Bulc is in favour - leading the line by jokingly coming out with a message that we should “think of the cows”. No, really.

Bulc said: “It’s a joke but it’s true, (for) cows it’s hard for them to understand they need to be milked one hour earlier or later.” Most a-moo-sing, Commissioner.  Times ahead, will tell…

Meanwhile, after Britain’s withdrawal, the number of Parliamentary seats will fall from the current 751 to 705, although none of the remaining EU-27 will have fewer seats in the new legislature.  The maximum number under the treaties is the current 751, 27 of the UK’s 71 seats will be shared out post-Brexit, with the remaining 46 set aside for any future enlargement.

This will not take away from Parliament’s influence in amending proposals and, on the contrary, the Brussels-based European Alliance for Personalised Medicine (EAPM) has been engaging with the sitting members to ensure that their influence in the vital field of European healthcare not only continues unabated, but will become more and more important.

EAPM already has cross-party support in the hemicycle through its STEPs group of MEPs. STEPs stands for Specialised Treatment for Europe’s Patients and has seen ongoing discussion between elected representatives and a wide range of stakeholders over any new laws having an impact on healthcare.

Advertisement

The Alliance has been key in influencing amendments in such areas as clinical trails, IVDs, data protection and, more recently, the Commission’s plans and Parliament’s amendments in the area of health technology assessment.

This engagement will continue going forward, also to include national and regional healthcare systems as well as relevant directorates-general of the European Commission.

One thing that politicians old and new in the Brussels and Strasbourg seats of Parliament need to be fully aware of is the emphasis that citizens, and thus voters, EU-wide put on health care, the price of it, new developments and access to the best care and medicines possible, regardless of personal circumstances both fiscally and geographically.

The foundation for the incredible scientific leaps in healthcare has, of course, come from innovation which has at its core cutting-edge research into, among other key areas, genetics.  Horizon Europe challenged by layers  Regarding research, legal eagles are swooping on proposals for the EU’s upcoming research programme, Horizon Europe, with the European Council’s Legal Service arguing that Parliament is being given too big a part to play in determining the details.

(Some may think that a little odd given the never-ending complaints about the EU’s ‘democratic deficit’, especially as those actually voters will be being wooed by directly elected MEPs, rather than lawyers, next May.)

Regardless, it will now go over to the Council to decide whether to demand amendments to the current proposal, which would of course slow down any agreement on Horizon Europe’s budget (it will be part of the 2021-2027 budget cycle).   Currently, the budget allocates some €95 billion for research and innovation in areas that include health.

The situation is clearly not ideal, certainly in the areas that touch on health care. And there may be trouble ahead. Indeed, Christian Ehler, MEPs was recently quoted as saying: “The arguments which have been brought forward are very problematic because it shows that the Council obviously doesn’t have the willingness for a fast procedure.”

Ehler also pointed out that inter-institutional squabbles are “not exactly the picture we want to draw of a Europe understanding that innovation is a key driver for jobs and growth”. Ouch.  As it stands, in an upcoming step, ministers are due to meet at the end of this month (28 September) while, ahead of that, Council ministers are discussing the matter in what looks to be another looming battle between Member States and the elected Parliament. It was ever thus.

Both Parliament and the current EU rotating presidency, Austria, are keen to have a political accord before those elections next year. But there is a possibility that the Commission will have to withdraw its proposal and send the whole matter back to the beginning.

So the Council may insist on changes, which may as noted mean it’s back to the drawing board, yet the Commission is currently of a mind to stick up for its original plan.

According to Wolfgang Burtscher, deputy director general for research: “The Commission considers that its proposal is legally sound and robust and therefore defends (it).”   In the event that the Commission holds its line, the Council’s own legal opinion is that there would need to be a unanimous member-state vote to bring in changes.

Budget grumbles rumble on 

Meanwhile, many stakeholders will be aware of the Parliament’s Environment, Public Health and Food Safety (ENVI) committee’s grumbles about the Commission plans to place health programmes under the umbrella of the so-called European Social Fund+, and is calling for the health programme “to be restored as a robust stand-alone programme”.

On the plus side, ENVI has welcomed the proposed increase in the budget and, “in particular, the dedicated envelopes for research and innovation in health’, which will sit at €6.83 bn).  Regarding a stand-alone health programme, ENVI says it has serious concerns “over the proposed reduction in funding for the health programme”, and “reiterates its call for the health programme to be restored as a robust stand-alone programme with increased funding…in order to ensure an ambitious health policy, including in particular a thorough increase in common EU efforts in the fight against cancer and easier access to cross-border health care”.  SPC waivers backed by ENVI  In other ENVI business, the committee has indicated its support for a first-draft opinion by Tiemo Wölken MEP on manufacturing waivers for supplementary protection certificates, or SPCs.

In it, Wölken has attempted to address a couple of the most serious complaints about the Commission’s proposal expressed by the generics industry. The draft seeks to amend the proposal to allow genetic-drugs producers to stockpile medicines, which would then allow them to sell them in the EU once the SPC expires.

The original proposal only allows the waiver for export purposes.  While generics companies would still be required to notify member state IP (intellectual property) authorities of plans to produce drugs under the waiver, the authority would not have to make the information public, thus taking into account industry’s argument that to do so would undermine confidentiality in respect of competitors.

The main thrust of the Commission’s proposal is to aid generics-makers in upping European-based manufacturing, with pharmaceutical companies saying that undermining IP incentives will have a negative impact on the EU’s research and development investment.

Wölken said that his amendments would help “reduce barriers to access to medicines,” and “reinforce the EU’s position as a hub for pharmaceutical innovation and manufacture, especially in the field of biosimilars, creating jobs and ensuring expertise remains within the Union.”

For its part, ENVI feels that the manufacturing and stockpiling waiver will strengthen the generic and biosimilar sector, while reinforcing the EU’s position as a hub for pharmaceutical innovation and manufacture, especially in the field of biosimilars, creating jobs and ensuring that expertise stays within the EU.

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