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#EAPM - Europos sveikatos priežiūra

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When it comes to health care in the EU we are facing challenging times, but there is also much innovation, so what does the future hold? Firstly, given the huge leaps in science (notably in genetics, but not exclusively) ongoing education for health-care professionals (HCPs) is key, rašo Europos asmeninio medicinos aljanso (EAPM) vykdomasis direktorius Denisas Horganas.

In whatever discipline young HCPs are working, they are facing the same challenge of keeping up-to-speed with fast-moving developments.  Not only that, but they - and Europe - need to work on methods for early diagnosis. Personalised medicine can target the patient’s disease in a more efficient manner, but prevention is generally better than cure.

Also, there needs to be much more inter-disciplinary understanding and communication between the next generation of HCPs. Silo thinking needs to go out of the window and the need to share knowledge and expertise across skill-sets and borders must come to the forefront.

To help facilitate this, EAPM is currently running its third annual Summer School for young HCPs. All this week, the highly interactive event is taking place in Warsaw, Poland. It is being hosted in conjunction with the Polish Alliance for Personalized Medicine, and also in cooperation with the Maria Skłodowska-Curie Memorial Cancer Centre and Institute of Oncology in the Polish capital.

Besides Poland, representatives from France, Germany, Italy, the Netherlands, Romania, Bulgaria, Spain, Sweden and more are attending the school.  Titled 'New Horizons in Personalised Medicine' the summer school comes under EAPM’s TEACH banner (Training and Education for Advanced Clinicians and HCPs), first launched in Cascais, Portugal, in 2016, and followed up in Bucharest, Romania, last year.

It is an ongoing initiative that aims to educate young doctors in the latest developments of personalised medicine.  Across the week, HCPs will attend lectures and workshops devoted to radiology, oncology, surgical oncology, haematology, molecular biology, plus personalised medicine in combination with immunotherapy, colorectal cancer therapy and molecular diagnostics.

The last two editions provided a highly interactive forum for sharing ideas for innovation, and practicing communication skills. Health care is a priority for all of our citizens - just ask them - especially in an ageing society. And HCPs are drivers in delivering health care, yet Europe needs to recognize that there are possibilities for collaboration between health-care systems across the EU and, furthermore, grasp them.  Training remains key, also. As an example of the work being done at this week’s summer school, a key session today (Wednesday 20 June) covered personalised medicine.

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In combination with immunotherapy, gastrointestinal diagnosis and therapy, the role of personalised medicine in diagnosis and treatment of colon cancer, plus a hemato-oncology session which also included a site visit in the Polish capital.  It is a small step in the right direction from EAPM but questions remain, which are being discussed at the summer school with around 100 young HCPs: How can member states shape the agenda on health and make sure that the framework remains in line with EU primary law? And which are the areas that provide added value. Also, what is the right framework and direction?  We can factor in, here, the current debate on the European Commission’s recent proposals regarding health technology assessment (HTA).

The proposal is aimed at improving the functioning of the internal market by harmonizing the member states' rules on carrying out clinical assessments for health technologies at national level, and at establishing a framework for mandatory joint clinical assessment (JCA) at European Union level.

This will likely prove tough to get through the Council given the member state competence for health under the Treaties.  Germany is one of the current nay-sayers, alongside France, the Czech Republic and Poland, with these potentially forming a qualified minority to block the proposal. They say that it could lead to a lowering of HTA standards and force poorer member states into having to buy expensive drugs.

Meanwhile, the European Parliament is debating the Commission proposal in meetings, while EAPM is doing the same. What is clear is that politicians and policymakers need to unite and retain a focus for the benefit of those needing innovative drugs and treatments.

The institutions are aiming to reach agreement by December 2018, with Parliament scheduled to adopt its position in October.  A meeting of health ministers on 22 June in Luxembourg will be key, this because there is a need for consensus before the European Parliament elections in May of 2019, and the arrival of a new Commission a few months later.

Despite certain objections, most member states do agree that there is room for common ground, (there has been a degree of cross-EU HTA co-operation for two decades), but the details need to be agreed before the new Parliament intake and the new Commission. Therefore stakeholders such as EAPM’s members, and of course patients, are emphasizing that there is no time to waste.  Currently, the legal basis for cooperation on HTA is Directive 2011/24/EU. Article 15 of the Directive contains an obligation for the EU to support a voluntary network of national authorities or bodies responsible for HTA.

The Commission’s original proposal, unveiled in late January, has a strong focus on overcoming impeded and distorted market access and the Bulgarian Presidency (which will hand over the baton to Austria on 1 July) has asked member states whether they would prefer a voluntary agreement, which would obviously allow some countries to opt out.

EAPM is strongly of the opinion that what is necessary here is improved co-ordination on EU-wide HTA, within a clearly defined framework, which may be difficult to achieve without some kind of mandatory element. What that would be remains a moot point.  Under the European Union’s social pillar each citizen across all member states should be able to have the same access to the best health care, often through earlier diagnosis. This is evidently not the case at the moment.

The Alliance believes that a truly constructive framework for JCA between individual HTA bodies is clearly required to cut down on unnecessary duplication. Striking a balance between a mandatory JCA and a voluntary one looks to be the only option at this stage, and it is up to the health council and its members to solve this issue.  On a general note, ‘health means wealth’ and, therefore, health policies (such as the EU-wide examples of legislation on IVDs, clinical trials, cross-border health and Big Data) have a special role in society.  But we need a much more cross-border and inter-regional dimension to aid the exchange of best practices. In the health domain it is often the case that a 'one-size-fits-all' solution is no longer feasible and, most certainly, no single country can facilitate necessary changes to modern health care all alone.

Whether or not the Commission proposal for mandatory JCA on HTA comes to fruition, the opportunities for expanding voluntary cooperation and coming up with a strategic vision on health across all member states are there, right now, and should be fully explored.

EAPM believes that it is important that any frameworks in the health arena stimulate and incentivize industry to deliver for patients, as they are what ‘health care’ is all about, after all. And let’s not forget that citizens’ trust in sturdy and safe regulatory frameworks is vital.

Despite national competences in healthcare, Europe needs to get together, cooperate, co-ordinate and share best practices for the benefit of all patients (and potential patients) across each and every member state.

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