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#HTA - European Parliament backs EU-wide action but patients denied key influence

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This week’s vote in the European Parliament plenary in Strasbourg to back legislation for EU-level health technology assessment (HTA) has been broadly welcomed by many stakeholders,
writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

But one key group has been sidelined - patients.

Parliament adopted the file by 576 to 56 (with 41 deputies abstaining) on the back of the institution’s Environment, Public Health and Food Safety Committee (ENVI) recommendations.

ENVI had thrashed out a broad set of compromises under the guidance of rapporteur Soledad Cabezón Ruiz. In the wake of the vote, the EAPM will hold a round table on HTA with member states' representatives on 6 November. The meeting will be hosted by permanent representations to the EU and will focus on the details of the compromises from a practical point of view.

The roundtable will look into the benefits arising from new legislation on HTA while addressing how to enable bringing innovation into healthcare systems in a truly practical sense.

Although patient participation had been addressed in compromise amendments during the ENVI meetings earlier in the summer and autumn, the proposed legislation is short on providing for adequate patient participation in the EU-HTA co-operation framework, suggest some patient-oriented groups.

In a joint statement, the European Cancer Patient Coalition (ECPC) and EAPM have expressed regret at the decision by Parliament to reject formal patient organization involvement “as equal and credible members of the Coordination Group” for the new legislation.

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As the two organizations state, patients have unique knowledge, perspectives and experiences, and are the ultimate beneficiaries of medical technologies. Therefore, patient representation is essential, they say, at all levels of decision-making when legislation directly affects their health andlives.

As part of the vote in Strasbourg, MEPs agreed to send the file back to ENVI to let the committee prepare for negotiations with other institutions, but the clock is ticking to get detailed talks under way before the May 2019 Parliament elections. The Strasbourg vote will serve as the basis for negotiations with member states.

EAPM has been a key driver of the benefits of joint HTA given its multi-stakeholder platform which acts as a bridge to policy makers.

It has aimed to translate key concerns from different perspectives in order to turn these into concrete policy changes.  The Alliance has looked hard at operational collaboration options to find out what works and doesn’t work in the EU net HTA.

EAPM has also been in close contact with MEPs through its STEPs interest group in the parliament (STEPs stands for Specialized Treatment for Europe’s Patients) and has held several round tables on the HTA topic.

Speaking after this week’s vote, rapporteur Cabezón Ruiz said: “The report adopted today aims at improving access to health technology in the EU, especially in terms of quality but also in choosing research projects according to medical needs.

She called it “a step towards guaranteeing the fundamental right of access to health” and “added value for patients and for public health systems”.

Cabezón Ruiz’s vision is of a European regulation on HTA to allow member states “to make the most reasonable choices for the patients and for the public budget, instead of letting commercial interests prevail”.

She added: ”The lack of an EU-wide system allows for certain treatments to be offered through public systems when studies show that they are not effective. For example, the price of anti-cancer drugs increased by up to ten times more than their effectiveness as treatments in the last decade. It has also been proven that a high percentage of new medicinal products brought into the European market offer no advantage over existing products.

For their part, ECPC and EAPM recognize that the regulation will help overcome disparities, reduce barriers to accessing innovative treatment, recognize the true value of new therapies, and improve the sustainability of national health-care systems.

They say that improving HTA and strengthening co-operation across countries will also provide better estimates of the medical and social value of new therapies and medicines. And they have noted the steps taken by parliament to address some of the concerns that the member states expressed regarding mandatory aspects, while calling for a “constructive dialogue to overcome challenges of the legislative file and to make sure that Joint Clinical Assessments become a reality in the European Union without detrimental delay”.

Any agreement will need a qualified majority in the Council - which means that 55% of member states must vote in favour practice (basically of 28) which represent at least 65% of the EU population.

Cabezón Ruiz added: "This report is a step towards guaranteeing the fundamental right of access to health. Nevertheless, we intend to take further steps. In fact, it is in the field of medical devices where more scientific evidence is needed to take decisions. It is an emerging market but it is still very fragmented, so a European evaluation will definitely be an added value.

"After today's vote, I have a mandate from the European Parliament to negotiate the final law with the member states. So far, progress between EU governments has been very slow. Now I hope they will speed up their work in the interest of European patients.”

Regarding any delays, the MEPs’ vote puts further pressure on the Council to adopt the measures. The mandatory aspects have proved to be controversial with early objections from France and Germany among other member states, although ENVI said that it supports the mandatory uptake of JCA reports and requires that member states shall "use" and "not duplicate" the assessment at national level. ENVI moved to address member state concerns by limiting the role of the Commission to an administrative function, and also extended the transition period for medicinal products to four years and to seven years for medical devices.

It highlighted “setting high standards of quality and safety for medicinal products and devices for medical use”.

Speaking at a recent EAPM round table, MEP Peter Liese pointed out that the role of HTA for assessing medical technologies is currently limited, being only conducted on 1% of technologies, and also only used in few countries.

He said: “Europe needs a framework to fill current gaps, which are legion, building on previous voluntary collaborations and ramping them up. It must formalize, improve and speed-up arrangements as they stand. The technology is clearly there to do this, if used properly and with serious intent.

“The over-arching goal is to take the best knowledge and proof of clinical effectiveness for a medicine or medical device from any given Member State and essentially share this to identify the best options that can be applied EU-wide,” the MEP added.

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