# הטאַ סיילז דורך # ENVI שטימען - אָבער עס קען זיין צרה פאָרויס ...

It’s a brand new week - and last week was certainly an important one in terms of the discussion on the European Commission’s proposals on an EU-wide system, or joint action, on health technology assessment (HTA), שרייבט EUROPEAN אַלליאַנסע פֿאַר פּערסאָנאַליסעד מעדיצין (עאַפּם) אויספֿיר דירעקטאָר דעניס האָרגאַן.

Meeting on 13 September in Strasbourg, the European Parliament’s Environment, Public Health and Food Safety committee (ENVI) overwhelmingly voted to adopt a series of compromises, thrashed out in the past months and weeks, in respect of the Commission proposal.

The figures were 40 votes in support, with three against and two abstentions.

MEPs involved highlighted that there are many barriers to accessing medicine and innovative technologies. In the main, this comes down to a lack of new treatments for certain diseases and the high price of medicines.

Quite a lot of the latter have little or no added therapeutic value.

It is worth noting that innovative health technologies are a vital cog in the wheel of an overall market for health care that accounts for some 10% of EU GDP.

The full Parliament is expected to vote on the issue between 1-4 October in plenary, but prior to that on 26 September, EAPM will be holding a roundtable meeting in Brussels on the topic, including matters arising, and members and stakeholders are invited to register דאָ.

אַדווערטייזמאַנט

The Alliance has been continuously involved with MEPs and stakeholders during a process that has seen some 60 amendments to the original proposal. EAPM will continue to engage with its own, and elected, members as well as member state health ministries going forward.

Those colleagues following the debate will know that controversy surrounded the EU Executive’s plans to make joint action mandatory and, while several member states (notably France and Germany) feel that the Commission has overstep its competence, Parliament’s Legal Affairs Committee backed its plans as lawful under single market sections of the Lisbon Treaty.

The legal experts found that the Treaty sets out that the EU shares competence with the member states regarding “common safety concerns in public health matters, for the aspects defined”.

Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, will contribute to the achievement of the objectives through adopting, in order to meet common safety concerns, certain measures relating to public health, the committee pointed out.

Among those measures are “measures setting high standards of quality and safety for medicinal products and devices for medical use”.

Crucially, Article 168(4) of the Treaty does not exclude any harmonization of the laws and regulations of the member states.

Overall, there is a need for health-care professionals, patients (and legislators) to understand whether or not a new medicine or medical device improves those that went before. This is vital when looking at ‘value’, especially in these tough times with increasingly cash-strapped healthcare systems under the cosh from, among other things, an ageing population and rising co-morbidites.

The Commission’s proposal contains provisions covering the sharing of data, among others, but a major sticking point is that, as suggested above, healthcare provision is a member state competence and jealously guarded. Notwithstanding, many member states have been loosely collaborating on HTA for two decades, although results have been mixed and unnecessary duplication has been rife.

Despite the vote in ENVI, there are therefore creases to iron out, although almost all of the compromises discussed under rapporteur Spanish Socialist and Democrat MEP Soledad Cabezón Ruiz’s watch were adopted in Strasbourg.

However in the face of this fact, plus the legal ruling and what occurs at plenary in early October, it may be more of a struggle to reach accord in Council. Time will tell, but there looks to be a battle ahead and the Austrian Presidency of the EU may have to carry the fight to resistant member states.

With the next European Parliament elections due at the end of May 2019, it may even fall under the auspices of the Romanian Presidency (which takes over on 1 January) to nail down a deal before the EU’s voters go to the polls.

Despite continued uncertainty, rapporteur Cabezón Ruiz spoke of recent events being “a good step towards improving European citizens' access to medicine and health technologies. The regulation will improve the quality of health technologies, inform research priorities and eliminate unnecessary duplication. Also, it has the potential to make the health system more sustainable”.

She also spoke about a clear added value for patients and for public healthcare in establishing an EU-wide system.

“Health is a fundamental right, and we must do our utmost not to let the market logic prevail, so we ask the Commission to propose a regulation on Health Technologies Assessment,” Cabezón Ruiz added, while pointing out that in the last decade, the prices of anti-cancer drugs have increased hugely when compared to their effectiveness, with only around 15% improving survival rates.

On high-risk devices - part of the so-called medtech sector - a still-sceptical industry will be given more time to comply with the eventual legislation. This received a cautious welcome from industry, which said it believes that, regardless, it must be proven that new regulations will have a positive impact and add value.

For its part, access campaign group Health Action International, labelled ENVI’s compromise proposals as a “considerable improvement” on the Commission’s original.

שער דעם אַרטיקל: