#EAPM - Health care: All the latest news from around Europe

Out and about in the EU 

Sometimes it seems as though Europe takes one step forward then two steps back in the health-care arena and, recently, Finland has been having a bit of bother with its attempts at healthcare reform. Prime Minister Juha Sipilä has ditched the plans as a result, and resigned just a month before national parliamentary elections, but the efforts and subsequent failures to enact reform are an old story in Helsinki and beyond.

For a decade and more, Finnish leaders have tried and failed to change a deeply ingrained but flawed system, even when all political parties have agreed that it needs to be done. Finland’s health care and social welfare systems are decentralized, with much of the admin in the hands of local authorities.

The end result for patients has been big differences in quality and access defined by geography - essentially a post-code lottery.  According to a European Commission report, due to the effects of an ageing population, healthcare spending in the country leapt from €14 billion (2000) to €21bn in 2015.  Attempts to centralize administration in certain areas, although generally agreed by most parties, have hit the rocks due to the finessing of any plans. The devil, it appears, is in the detail and we again have an impasse.

Sipilä wanted to centralize at a regional level, but this came alongside other suggested reforms allowing more privatization. The left-leaning and Green partieswere not happy with that idea. Finland’s President Sauli Niinistö has asked Sipilä to stay on as a caretaker leader until the mid-April elections. Complicating matters still further is the fact that Finland takes over the rotating EU Presidency on 1 July.

So, we watch and we wait…

Getting clinical

Meanwhile, Denmark - in its role as head of the common European subgroup for complex clinical trials with trial subjects - has overseen publication of a set of recommendations for developing personalised medicine.

The recommendations aim to ensure a continuous assessment of the effects and side effects of investigational medicinal products, the safety of trial subjects and transparency of the data being used.

The recommendations also define what may reasonably be considered a complex clinical trial and what should be considered as separate clinical trials. As we all know, the development of personalised medicine is gaining ground, and clinical trials with trial subjects are becoming more complex.  The development of new medicines against a personalised medicine background tend to have fewer selected patients. The selection could, for example, be based on their DNA profile. The Danish Medicines Agency has co-ordinated the working group for complex clinical trials.

Recognizing the need to define barriers and develop putative solutions to the integration of personalised medicine into, specifically,clinical cancer research and care, EAPM in the past assembled a multi-stakeholder panel to address whether personalised medicine-enabled clinical research/clinical trials strategy could underpin better outcomes for cancer patients. The Alliance found a need to empower a paradigm shift in clinical cancer research and its implementation for improved patient care.

The clinical trial wheel is broken, EAPM found,and there is a need to develop innovative solutions to fix it. The model of modest increases in benefit may have defined successful clinical trials of the 20th century, but is no longer pertinent for the personalised medicine approaches of the molecular era. Clinical trials and clinical cancer research must increasingly be more co-operative (bridging the academia – industry intersect) and deliver benefit.

The EU’s patients both deserve and demand transformative rather than incremental change. But this transformative change must be delivered within affordable and sustainable healthcare systems. Personalised medicine must be progressive, but it must also be pragmatic. The escalating cost of cancer medicines in particular is not sustainable, even for large economies,while a cost-versus-value lexicon must be defined, with a specific emphasis on delivering increased benefit from a health, innovation, economic and societal perspective.

Europe needs an innovative clinical trial culture that matches the trial to the patient, rather than finding the patient for the trial. Increasingly, the EU must move away from the traditional single-arm approach to a more nuanced multi-arm, multistage clinical trial algorithm which is supported by a precise molecular stratification strategy.

The future is represented by biomarker-informed multi-agent clinical trials. In addition to bridging the academia-industry intersect, these approaches will increasingly require new partnership models, leveraging international collaboration and promoting multi-pharma collaborative networks.

Realizing the potential of personalised medicine requires the integration and alignment of multiple stakeholders across the health-care system.

Dialogue between stakeholders should be initiated early to ensure that innovation and “real” benefit is rewarded, while proposed therapeutic approaches with limited potential to deliver better clinical outcomes should “fail” at an earlier stage, thus limiting  costs and reducing patient participation in  clinical trials that deliver little or no clinical benefit.  Enhancing and maintaining quality-assured clinical trial infrastructures, through organisations such as the European Organisation for Research and Treatment of Cancer (EORTC) must underpin  the development of new therapies.

Without innovative clinical trials in Europe, patients’ access to personalised medicine is at risk, but this innovation must occur within a culture of rigour and transparency, thus ensuring optimal quality care for patients.

Of course, another much-needed foundation is common European guidelines(as EAPM and its fellow stakeholders have often noted) to harmonize the conduct of trials and ensure high-quality data plus the safety of trial subjects.  The work of Denmark and the group it is leading is much needed and to be welcomed.

No-deal Brexit?

A glance through member state planning  It’s another busy, and crucial, week ahead for the UK House of Commons and, while the European Commission has already published 78 notices with detailed guidance on planning for a no-deal Brexit in areas of EU competence, member states are also making their own plans.

Ireland, for example, will have to pass what it calls an Omnibus Bill. This consists of 17 parts, ahead of 29 March if Britain leaves without an agreement.  In the arenas of health and social protection, the Omnibus Bill will ensure continued payment of 21 social protection benefits, including pensions, illness benefits and child benefits.

Meanwhile, Dublin is acting to allow health-care provision to stay the same, with Ireland’s Health Services (HSE) covering the cost of health care provided in the UK. under the same conditions as currently.  The HSE and the Health Products Regulatory Authority are cooperating to identify potential risk areas and vulnerable product lines, and find solutions to maintain market supply of medicines.  The government says that work to mitigate supply chains is well underway.  On top of this, Ireland wants to ensure that any insurance contracts signed before ‘Brexit Day’ will continue to be serviced.

For citizens of the Netherlands, those Dutch nationals living in Britain will continue to have access to the NHS, but will cease to have to pay a contribution back home with the bill no longer being charged to the Netherlands.  Also, a scheme will come in to play to allow a (small) group of Dutch beneficiaries in Britain to complete ongoing treatments outside the UK in a post-Brexit world.

And UK citizens living and/or working in the Netherlands are insured on the basis of Dutch legislation and are obliged to purchase health insurance.  The European Health Insurance Card, allowing EU travellers free emergency care and care for chronic diseases while on holiday, will become invalid in a no-deal scenario.

And, to avoid potential problems in the supply of certain medicines and medical devices, the Netherlands has called on companies in the health sector to prepare in terms of inventory and compliance with EU market requirements.  Meanwhile, in Germany,British citizens will have three months to apply for a German residence permit. During the application process they can continue to live and work in Germany. Also, Britons  applying for German citizenship ahead of a no-deal Brexit will be treated as EU citizens.

France will allow British nationals living in the country when the UK leaves the EU, and receiving the Revenu de solidarité active welfare benefit, continued eligibility for a year. The benefit is aimed at reducing the barriers to returning to work.  The continuity of health-care coverage,under current conditions which derive from EU law, will be ensured for two years.

In Belgium, if a no-deal turns out to be the case, the social security rights of British citizens in the country will remain protected after 29 March, at least until the end of 2020, based on a reciprocal arrangement with the UK.