Collaboration will aid health innovation in Europe

| November 17, 2014 | 0 Comments

snreOpinion by European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

We live in innovative times, especially in the world of health care, with personalised medicine coming more and more to the fore, courtesy of groundbreaking research, new technologies and exciting developments in medical science.

A major problem, however, is that making the best use of such developments in the arena of health care is particularly expensive and difficult, given the hurdles that need to be overcome, for example, regarding evaluation and approval at regulatory level – a long drawn-out process in most cases.

On top of this, figures suggest that, on average, it takes more than 1 billion to develop an idea into a marketable and potentially profitable product and it generally takes from ten to 15 years to get the product from bench to bedside. This is clearly far from ideal both financially and from the point of view of the patient, who could theoretically be benefiting from innovation much earlier.

Also, we are now living in a Europe of 28 member states, many of which are relatively small and do not have the financial resources or, often, the health care infrastructure to match that of their bigger neighbours.

So, what can be done? The European Alliance for Personalised Medicine (EAPM) believes that; for a start, a multi-stakeholder approach is necessary to overcome hurdles and break down the barriers.

Not only that, but EAPM also recognizes the added value that smaller member statesas well as regions in the larger ones – can bring when working towards health care systems that offer the best treatments and outcomes possible for all citizens.

Back in 1992 the Maastricht Treaty gave the EU a legal public health mandate for the first time, which was later updated in the Amsterdam Treaty. Article 35 of the EU Charter of Fundamental Rights states: “A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.”

However, health and health care systems remain a member state competence, even though the EU does have a complementary and supporting role by shaping the conditions for, among other things, health workforce mobility, the purchase of goods and supplies, the financing of health systems and the delivery of services. Many laws have also been

During the pre-2004 accessions negotiations, smaller member states were given a special mention in the famous ‘Cyprus clause’ (Article 126a), which gave these countries, for example, an abridged form of registration for medicines. But, despite such provisions, these smaller countries are clearly more vulnerable. However, because they need to collaborate more, they tend to have a more positive approach to networking and exchanging best practices, something that many lager member states could perhaps learn from.

EAPM is of the view that, in order to achieve a high-level of health care right across the EU, health policies need to recognise and tackle the health system vulnerabilities faced, specifically, by these smaller nations as well as those in the regions of the larger ones.

This model should see the development of a new socio-economic paradigm that: acknowledges the growing rift between citizens’ expectations and the realities; finds a level between raising their expectations and current crisis/supply constraint scenarios; ensures that current inequalities do not get even worse; reduces administrative burdens while avoiding new bureaucracies and authorities, and; minimizes and simplifies reporting obligations to tie in with the EU’s ‘better regulation’ agenda.

Generally speaking, across Europe, there is quite clearly a need for more co-operation and coherence in planning among, for example, patients, policymakers, academics, clinicians, governments, SMEs and, of course, the pharmaceutical industry when it comes to bringing down costs and ensuring that procurement rules and reimbursement policies work quickly and effectively. This would clearly best serve the interests of the European Union’s 500 million citizens across all of its 28 Member States, large or small.

In a Europe where the EU; as previously mentioned, has no official legal competence over health care, it surely has to be the case that individual states, as well as regions within those states, collaborate to bring about better health care for all.

Early stakeholder involvement is key at every stage, for example in the development of indicators measuring outcomes which, apart from anything else, would aid investors.

Meanwhile, as a major plus point, stakeholders – including the pharma industry and medical community – recognize the value of involving patients at every stage of the development of a medicine or treatment: a cornerstone, as it turns out, of personalised medicine, as is co-operation between all stakeholders.

EU initiatives such as IMI are helping this process and involving more and more SMEs – good for innovation and great for the economy.

In this brave new world of the internet, great leaps in genetics and the emergence of ‘big data’, there has never been a better time to place new technologies and developments at the feet of all, but this can only be achieved through the breaking down of silo walls – in every stakeholder arena – and through stepped-up collaboration.

In a Europe where there is a limitation on the legal powers of the EU in the area of health care, it is up to the stakeholders in every sector, and in every member state, to come together and make the most of the gifts at their disposal.

Through its ongoing STEPs campaign and the events planned for 2015, EAPM will continue to strive for such cooperation. A better future awaits for the EU’s patients – whether they live in smaller or larger member statesbut it will take all of us, acting together, to make the endless possibilities become reality.


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Category: A Frontpage, EU, EU, European Alliance for Personalised Medicine, European Commission, Health, Opinion, Personalised medicine

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