#EAPM - European Parliament confirms position on #HTA as chance of pre-election deal disappears

Valentine’s Day (14 February) it may be, but there is still little love lost between those member states who back mandatory EU-wide joint action on Health Technology Assessment (HTA), and those who don’t, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

But it hasn’t stopped the European Parliament having a debate and a vote on the HTA issue in the latest Strasbourg plenary session. The debate was to confirm and conclude Parliament's position, first adopted last October, because Council has yet to find a common one, nor has it opened inter-institutional negotiations.

Time has already run out for three-way discussions before the elections in May and the position was passed by a simple show of hands. Speaking at the pre-vote debate, the Commissioner for Health and Food Safety, Vytenis Andriukaitis, said he regretted that the Council had been unable to agree on a position. His sentiments were echoed by MEPs.

Parliament came to the not-very-surprising conclusion that its own position is balanced, given that it takes into account member states' concerns over the issues. It also underlines that decisions regarding reimbursement and pricing will remain a competence for individual countries with clinical assessments being made at EU level.

The ultimate goal is, of course, to improve patients' access to medicines. This is a goal shared by the Brussels-based EAPM, which has had huge amounts of interaction with all the key players in the HTA field, not least national health representatives, rotating presidencies, MEPs, medical experts and governing bodies. The ENVI committee’s Soledad Cabezón Ruiz, who is rapporteur on the issue, reaffirmed her commitment to the idea of Europe-wide HTA during the debate. The Spanish MEP told colleagues that the Commission's proposal was timely and offered EU added value.

She pointed out that, while the European Medicines Agency authorizes medicines after assessing quality and safety, it does not look at added value. This places a burden on health systems, she said.

Cabezón Ruizdescribed the initiative as being driven by a mismatch between research and medical needs. High prices for medicines and treatments do not necessarily lead to added value, and member states look at quality in setting reimbursement rates.

A little background…    

Despite positivity from the European Economic and Social Committee, and the backing of Parliament for the mandatory parts of the Commission’s proposal, several member states have objected, some raising subsidiarity concerns in health care, which comes down to closely guarded national competence.

Meetings have been organized, discussions have been held - not least by EAPM - but the debate rumbles on.

The Alliance will support the rotating presidencies - Romania and Finland - throughout 2019 as the plans hopefully begin to nudge forward. During the latter part of 2018, the rotating presidency of the EU, Austria, worked hard to make progress, tabling a revised text, based on written and oral contributions by delegations.

Austria introduced provisions that require definitions of the content of the joint clinical assessment, or JCA, be defined. This was in respect of interventions, comparators, patient population and patient-relevant health outcomes. On top of this, Austria worked to clarify the selection of experts to carry out JCA, transparency and confidentiality rules for participating in the joint EU work, the information to be submitted by the industry, plus the procedural steps and timelines.

But in the end, despite its best efforts, Vienna was forced to acknowledge that disagreements could not be overcome at that time. So now the ball is in the court of its successor, Romania, which has taken on the presidency for the first time. Bucharest is on record as saying that it is keen to avoid the political battle over mandatory versus voluntary aspects of the Commission’s HTA plans. Romania has essentially set its sights on a technical compromise first, followed by a political one at the end of its presidency. This will be post-elections at best, and the baton may be passed to Finland.

So, where next on HTA?  Having admitted that it will effectively hold a “transitory” presidency as we head towards the May Parliamentary elections, Romania is however aiming to reach a political agreement among member states on HTA, according to Sorina Pintea, the country’s health minister.

“Romania’s presidency aims at continuing negotiations in order to make as much headway as possible in order to reach a general approach at Council level,” she said, while talking about a “realistic” approach and relying on collective efforts “and a strong political will”. Back to Strasbourg, and the Parliamentary debate this week heard that, when it comes to treatment of rare diseases, adequate clinical evidence is vital.

The European Parliament aim to have a set procedure in place to ensure quality of research and one that matches the needs of patients. Cabezón Ruiz said Parliament's position looks to ensure faith in the HTA process, while guaranteeing independence, transparency, and scientific rigour. Member states could still carry out their own reassessments aligned with their national circumstances, looking at specific issues such as social, economic and ethical aspects. The proposal allows for cooperation on emerging health technologies, the rapporteur said, insisting that the issue cannot justify stubborn opposition from member states, who should take a more constructive approach. If this impasse remains, then patients will be the losers.

Three MEPs who have worked alongside EAPM on many occasions had their say in the debate.  Lieve Wierinck, speaking on behalf of the ITRE Committee, said that thanks to European co-operation, patients suffering from rare diseases have better access to medicines and treatments that are effective for their condition. The opportunity is also there for member states to access a large pool of clinical trial data. (This dovetails into the MEGA initiative championed by EAPM, which not only seeks to use EU-wide co-operation to garner a cohort of one million genomes in the next few years, but also focuses on the sharing of any data useful in healthcare, albeit under robust ethical conditions.)

Cristian-Silviu Buşoi stated that joint clinical assessments should occur at EU level to improve access to innovative drugs, but without jeopardizing decisions by member states. Such a situation would increase health levels in citizens and aid he functioning of the single market. And Gesine Meißner highlighted the cross-party cooperation on the legislation in Parliament. The German MEP added that medication does not need to be authorized up to 28 times, and that simplification would benefit everyone.

She acknowledged that there is a great deal of scepticism from member states, including big countries such as Germany and Spain, but pointed out that smaller countries understand the benefits. For his part, Commissioner Andriukaitis expressed regret that negotiations between the institutions have not yet begun. He said Parliament’s views will send a clear signal for the need to work on the file, as the EU moves towards the end of this mandate and on to the next one. Andriukaitis said that the Commission is working with the Council, and he welcomes the Romanian Presidency position on moving the negotiations forward.

He added that national authorities will be able to pool their resources,and industry will benefit from increased predictability. However, above all, the proposal is about Europe’s patients, who are at the heart of the proposal, he underlined. The new model has clearly the potential to improve access to health technologies, he told MEPs. It is now important to encourage member states to reassess their positions and find an agreement as soon as possible. Adjustment on pharmaceutical IP rights agreed. Also this week, the Commission welcomed an agreement reached by Parliament and the Council on an adjustment it put forward in respect of intellectual property (IP) arrangements for pharmaceutical products.

The amended rules keep the strong existing IP rights in order to encourage innovation and research in the EU, but will make it easier for Europe’s companies to export generic and biosimilar medicines to third countries,where IP protection has expired or didn’t even exist. Commissioner Elżbieta Bieńkowska, who is responsible for the Internal Market, Industry, Entrepreneurship and SMEs, called the adjustment “well-calibrated” and said it will help “Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU”.

“We are removing a major competitive disadvantage of EU manufacturers who will soon be able to compete on equal terms in global markets where competition is fierce,” she said. The agreement reached by co-legislators is now subject to formal approval by Parliament and Council.

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