Opening Session: Setting the Scene – What can innovation bring and why this is important

It is well documented that EU citizens value good healthcare very highly - it is a priority and policymakers generally know this (if they don’t, then they should). Equity of healthcare across Europe does not really exist unfortunately, for various reasons, but it is a prize goal that politicians and stakeholders have little choice but to aim for.

The large differences in health care expenditure across different countries cannot be explained entirely by the demographic, economic or technological differences. Legal and institutional architecture of health care provision and financing is undoubtedly an important factor influencing the public and private spending in the sector. However, high complexity of the system and variety of its features makes it very difficult to quantify and compare across the countries. This session will feature a chair plus six speakers representing the political, institutional, regulator, patient, medical, and scientific perspectives.

Session I: Technology Developments

Europe's achievements in science and technology have been significant and research and development efforts form an integral part of the European economy. Europe has been the home of some of the most prominent researchers in various scientific disciplines, notably physics, mathematics, chemistry and engineering. Scientific research in Europe is supported by industry, by top-level European universities and by several scientific institutions. The raw output of scientific research from Europe consistently ranks among the world's best.

However, the EU and regions have struggled to bring innovation into the bloc’s healthcare systems. Therefore, this session will look at the potential that technological development can bring and the cost savings that constitute a key bonus. The session will touch on the policy initiatives that have supported this over the years as well as looking toward the next legislative periods and the frameworks which could support this. The format will again see a chair plus six speakers, once again representing the political, institutional, regulator, patient, medical and scientific perspectives. Discussion from the floor, as well as questions and answers, are key to the session as ever.

Session II – Haematology – Personalised Treatment and Personalised Prevention

Blood cancers are in the top ten of the most common forms of cancer and are responsible for approximately 100,000 annual deaths in Europe.

This means that the proportion of healthcare costs within the total economic burden is higher for malignant blood disorders than for other solid tumours.

Figures suggest that healthcare costs for each patient with a blood cancer are double the average for the treatment of other cancers.

The total cost of blood disorders to the European economy was already in the region of €23 billion in 2012 ,and it is expected that this will rise still further down the line.

Some 80 million people are suffering from either malignant or non-malignant haematological disorders, and mechanisms for diagnosis and treatment need to be streamlined and improved as a matter of urgency.

This session will look at various aspects, including accurate measurement of the economic costs on a population in relation to the treatment of specific medical conditions, the need to improve acquisition, integration, harmonisation, and communication of data related to blood cancers, as well as ways to facilitate the approval of new medicines.

Clearly, the better use of data, which will take into account demographic differences and which will foster greater patient engagement, is set to be an effective tool for determining therapeutic options for individual patients.

This fits with the ethos of personalised medicine bringing targeted patient care and treatment, while ensuring that all approaches are patient- and outcome-orientated.

Big Data also has the potential to help healthcare professionals more quickly identify and define promising treatment strategies. It also aids them in predicting any adverse effects likely to be associated with such interventions.

Against this backdrop, many stakeholders point to a need for public action to tackle the effects of blood cancers in Europe.

As awareness of this has grown, calls for challenges to be addressed have also increased. Suggestions have included tackling inefficiencies in healthcare systems, while earlier diagnosis is also key.

Stakeholders say that it is now of paramount importance that a pan-European approach to the creation of new tools is developed.

Session III - Pharmaceutical/diagnostics - Regulatory Framework

While medicinal products and the screening of genomic characteristics with diagnostic tests are closely inter-linked in personalised medicine, the current EU regulatory frameworks for the marketing of medicinal products and the corresponding diagnostic medical devices are different.

Medicinal products administered to the patient fall under a specific regulatory framework, while diagnostics are covered by legislation governing in vitro diagnostic medical devices.

While the different pathways are justified by the different nature of the products, both frameworks aim to ensure a high level of public health protection and to promote the functioning of the internal market, with measures which also aim to encourage innovation.

The format of this session will follow the previous discussions and, as ever, input from the floor will be actively encouraged.

Session IV – Impact of Brexit – Strategic Investments for the Future of Healthcare

With the final shape of Brexit (if it actually happens) in more doubt than ever, and Prime Minster Theresa May hanging on to her job by a thread, voices on all sides are asking “What next?”

Mrs May’s Brexit deal was flattened in a record-sized defeat by 432 votes to 202, with her own Conservative Party rebelling and, soon after, she narrowly survived a vote of no confidence in her government.

That time at least, her party rallied around and Northern Ireland’s DUP rode to the rescue.

The prime minister won by 325 votes to 306 and the DUP, which opposes any backstop arrangement over the Irish border issue, could have swung it the other way, by one vote (316-315), had its ten MPs gone against her.

Mrs May is now scrabbling around trying to get some kind of Parliamentary cross-party consensus, with the official opposition Labour Party refusing to engage until the prime minister makes it clear that a no-deal Brexit is no longer on the table.

Meanwhile, in Brussels and beyond, EU leaders are refusing to renegotiate the current deal, or even meet the UK prime minister at the weekend although, regardless, Mrs May must go back to Parliament with a ‘Plan B’ in double-quick time.

It’s fair to say that, right now, it’s all something of a mess.

Worried that Britain may crash out of the EU at the end of March with no deal - hard Brexit - the pharmaceutical lobby group EFPIA has called on EU and UK policymakers to put politics aside and prioritise patients in planning for a such a scenario, stating that there are now “very real, tangible and immediate threats to patient safety”.

Meanwhile, Mike Thompson, who is head of the UK’s ABPI group, was quick to warn that “no deal would prove to be extremely challenging”. This despite medicine stockpiling and duplicating manufacturing processes across the industry.

To add to the clamour, the British Medical Association has gone so far as to call for a second referendum.

This session looks at how Brexit will affect the UK and its supra-national dealings with other health care bodies throughout Europe, not least on the basis that there is already a huge need for better cooperation across medical disciplines and borders. Britain’s departure will hardly help.

Post-Brexit, the UK will probably have access to smaller data sets than those in the Union. Not only that, but the EU may lose potential data from the UK. This effectively means less collaboration and sharing of information and promises to affect patients, be less efficient and more expensive.

It remains to be seen what, if anything, can be salvaged from a worrying situation.

Closing Session - Political Will and Institutional Support.

The incoming MEPs and European Commission will be vital as we attempt to bring the potential of personalised medicine to fruition.

EAPM has always had as part of its mission the raising of awareness among policymakers of the issues going forward in this arena.

Those with legislative influence need to be appraised of the opportunities being offered by new technologies and be encouraged to walk through the labyrinth that can slow down progress. Without good legislation loving forward effectively will be difficult and it is EAPM’s aim to ensure that options are as open as possible.

With or without the UK, personalised medicine is moving forward in many areas.

For example, the European Commission’s Digital Day 2018 in April saw a major commitment on behalf of a coalition of willing Member States, alongside the Commission, to join genomic databanks at an EU level for medical research.

Key to this is a one-million European genomes target.

More than a dozen EU Member States signed up to the declaration, agreeing to work together “towards building a research cohort of at least one million genomes accessible in the EU by 2022”.

Overall, there is a clear need to provide value for money in cash-strapped healthcare systems that are struggling with ageing populations, dealing with a new clinical trial paradigm in the wake of the discovery of more-and-more rare diseases, and collapsing under the weight of a huge increase in co-morbidities.

Policy- and law-makers need to get up-to-speed with the developing technologies surrounding personalised medicine, investment opportunities, education of healthcare professionals, and providing the right treatment to the right patient at the right time, not least as part of the EU’s social contact.