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#EAPM: Nouvo #HTA bouyon rapòte pou deba nan ekspè swen sante sou 6 jen

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The European Parliament’s draft report plans to amend the directive on health technology assessment (HTA) will be the topic of a key Brussels meeting on 6 June before the European Parliament ENVI Committee discussions on 7 June, ekri Alliance Ewopeyen pou Direktè Egzekitif Medsin pèsonalize Denis Horgan. 

The Parliament itself will host the Alliance-organized meeting being held to scrutinize the report distributed by rapporteur Soledad Cabezon Ruiz, MEP, and EAPM is generally in support of the direction of the contents.

The Commission’s proposal aims to introduce joint clinical assessment of health technologies at EU level, although this has met with some opposition from certain member states who traditionally guard their individual competence in health care.

The Parliament’s draft, however, praises the Commission’s proposal as ‘timely’ saying it represents high-added value. Parliament also feels it represents a further step towards closer EU integration in the health arena.

The report notes that the harmonization of medicines at EU level dates back to the 1960s, and cites the setting up of the European Medicines Agency as recently as 1995. Since then a further Directive has been the main basis for pharmaceutical legislation across the bloc.

Parliament states in its draft that any policies regulating health and health-care provision must have the aim of guaranteeing access to medicines for patients. Yet there is a great deal of concern regarding the reality of the situation. It argues that Europe needs more and better clinical evidence, to determine the efficacy and therapeutic advantage of medicines.

Until now, member states have made decisions on efficacy and value on an individual basis, but the Commission and now Parliament believes that joint clinical assessment is the way forward. They base this partly on a need to avoid duplication across member states, caused by a lack of clinical evidence across the EU and sub-optimal communication. Other areas need improvement, the draft says, such as clinical evidence in respect of medical devices. Meanwhile, Parliament feels that the proposal may bring about more collaboration in fields such as personalised medicine.

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It adds that new ways must be found to deliver more of these personalised medicines, especially in the case of rare diseases and smaller groups, areas that EAPM firmly supports. In an article ‘The Three-Way Pendulum of Healthcare Innovation’, the Alliance pointed out the high cost of bringing innovative new drugs and treatments to the health-care market, especially medicines for smaller subgroups, and the fact that member state health systems often baulk at the prices.

EAPM and its multi-stakeholders believe bypassing and blocking innovative medicines and treatments is not only counterproductive when it comes to the health of Europe's patients, but actually fails to take into account the economic arguments. The long-term benefit to patients and the economy will outweigh initial costs down the line, the Alliance argues. Couple this with a smarter use of information technologies and other resources and it will be possible to get much closer to building sustainable healthcare systems in a Europe struggling under the burden of an ageing population.

For most health care innovations, the procurement decisions are made not as a result of a value judgement by the customer, but by intermediaries who have their own economic balances to strike. Innovators obviously need the prospect of a return that justifies and incentivizes their efforts. Given the accelerating shift towards personalised medicine, with all its promise of benefits for society, but often focused on smaller groups (or markets) this is tough to achieve. HTA calculations often fail to take into account the potential savings that might result not only from the use of a better therapy but also from more precise and evidence-based prescribing.

Meanwhile, innovation is receiving less encouragement while the innovations that personalised medicine offers, which often aim at sub-populations as noted, are discouraged. As the article notes, payers may be happy by keeping their drug bills in check - but patients are often left untreated even when new treatments are available. Meanwhile,  innovators certainly wonder whether they can risk further investment. The Alliance argues that part of the modern-day healthcare challenge is the need to review how health systems can be sustainable. This must take account of how resources are allocated, and how the right technologies can be efficiently used at the right time for the right patient.

Essentially, a great deal of the debate is about the best allocation of resources across health-care systems. Smarter use would take advantage of possible cost savings, by viewing costs strategically rather than merely at the level of individual costs such as drugs and hospitals.

Of course, where it is possible to treat a patient with an older, cheaper medicine, it should be done, but if a patient can benefit from a more modern treatment, access should be provided. Getting this balance right creates a win-win situation.

A new joint clinical assessment system across the continent will have its part to play, as the Commission and Parliament clearly believe, and the trick is finding the very best way to do this and persuading the EU’s individual countries to buy into the idea. Done correctly, it will certainly go a long way to creating a ‘smarter’ healthcare environment.

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