#BalkanStates look to work together on personalised medicine

| October 21, 2019

This week (24-25 October) will see the Second Balkan Conference on Personalised Medicine taking place in the Bulgarian capital of Sofia, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

It may also see some movement on the Brexit situation, but nobody should be holding their breath… Unlike Britain’s bid to leave the EU, the event in Sofia has been built on realistic, clearly defined and solid foundations, in this instance by the Bulgarian Alliance for Precision and Personalized Medicine (BAPPM), in collaboration with the Brussels-based European Alliance for Personalised Medicine (EAPM), the Medical University Pleven, and the Bulgarian Society of Human Genetics and Genomics.

This key conference – Forward Together in the Personalised Medicine Era-takes into account the broad impact of personalised medicine, which promises to create a new paradigm in healthcare. Given that no Member State can realistically go it alone when it comes to modern-day health care, the key question is how to move forward.

Finland moves on cancer and ERNs The conference comes in the week that the Finnish Presidency of the EU has brought out its draft Council Conclusions, which highlight issues that EAPM has long championed, including a cancer plan. This is long overdue after the European Partnership for Action Against Cancer of almost a decade ago, and the question of how to translate plans into tangible action remains. The key now, as the Finns have noted, is to ensure sustainability and availability of health services for medicines,as well as a surge forward inmolecular diagnostics.

The plan, which as we know is fundamental to the Ursula von der Leyen Commission’s agenda, looks to support EU countries in their efforts to “prevent cancer, address early diagnosis and treatment, and improve the lives of patients and survivors”.

The draft also calls on the Commission to support member states “through appropriate actions within its competence, in their endeavours to improve the sustainability and availability of health services, including access to medicines and medical devices”. Finland’s draft conclusions meanwhile note the “shortages and high prices of a number of medical devices and medicines” that, combined with inefficiencies in using generics and biosimilars, “can threaten the sustainability and financing of national health systems”.

The conclusions also highlight the need to improve access to – and the cost-effectiveness – of medicines, and calls on policymakers to continue discussions on affordability and security of supply.

Meanwhile, member states acting through the Council of Ministers have told the Commission to continue funding European Reference Networks (ERNs), while developing the e-health Digital Service Infrastructure. This enables the voluntary cross-border exchanges of patients’ health data.

ERNs, the virtual networks gathering knowledge on rare diseases across the EU, need simplified financial and administrative procedures plus a reduced administrative burden, as well as continued finance “with a view to their long-term sustainability, say the member states.

ERNs are one example showing that cross-border collaboration is vital and, with this in mind, countries in the Balkan regionare aiming to work side-by-side todevelop a coherent action for public-private collaboration between the relevant countries, creating a model that others may follow.

All of the above will be on the table at the Balkan Conference as well as at EAPM’s own Congress in early December.

The goal of enhanced collaboration

Also key for engagement in Sofia is the role of the the MEGA+ initiative on all types of health data sharing, which again relies heavily on cross-border collaboration.

Alongside MEGA+, Europe needs to develop a framework that will enable the sharing of best practices within, in this case, the Balkan region, and develop a coherent action for public-private collaboration between the relevant countries, creating a model that others may follow.

Unfortunately, certainly in a health-care sense, there is too little co-operation to tackle the problems that beset our ageing society, which include under-resourced health services, an age spent getting new drugs to market, an increase in chronic diseases, as we’ll as not enough prevention, including screening programmes.

There are solid arguments that what we need is more, not less, Europe – and for practical purposes that means less silo thinking and more cooperation, across borders and across disciplines. With this in mind, Digital Economy and Society Commissioner Maria Gabriel, who is expected to remain a commissioner in the von der Leyen administration, will be present in Sofia.

Speaking ahead of the conference, Dr. Jasmina Koeva, chairwoman of the Board of BAPPM, said: “This is a very important event for our region with the over-riding goal of acting asa stepping stone in establishing the fact that enhanced cooperation is necessary as we strive to make personalised medicine the norm in modern-day health care.”

EAPM’s Executive Director Denis Horgan said: “Breakthroughs in genetics, calls for more and better screening, developments in imaging techniques and the emergence of what we now call ‘Big Data’ have already changed the world of health care for ever. All for the benefit of patients. “But we need to share more of these new scientific methods and enable higher levels of collaboration.This holds true in the Balkans as anywhere else.”

Topics at the conference

With rising health-care costs and systems being increasingly challenged, genomics has the potential to impact the health of all of us and provide diagnostic, economic and efficiency benefits, ensuring a patient has the right information, to get the right treatment, at the right time. 

Also hugely important for healthcare (and fiscal) reasons is the preventative sector which involves screening and early, precision diagnosis. Please see the link to the agenda.

A session at the conference on The Pathology of Personalised Medicine will look at molecular pathology – specifically at new achievements and implementation in clinical practice – as well as precision imaging in modern-day healthcare.

A further plenary session will look at personalised medicine in oncology and haematology, and cover screening, targeted and combined therapy, plus adjuvant and neo-adjuvant therapy.

Also covered will be immunotherapy, radiotherapy, the monitoring of lung cancer, as well as colon cancer, prostate cancer, melanoma, pancreatic cancer, and head and neck cancer.

Personalised medicine and rare diseases as well as personalised medicine in endocrinology will also get their time in the Sofia spotlight; while the conference will bring virus infections, neurology and psychiatry into focus in a personalised medicine context.

Five key aims will dominate the conference, which require the Balkan states to:

  • To speed-up the process of exchange of electronic health records (EHRs) and ePrescriptions while, at the same time, creating an environment in which more of the public become aware of cross-border healthcare, are aware of their rights under the directive, are confident and informed enough to make use of it, and have faith in the reimbursement systems. relevant to this is to offer more support to European Reference Networksin the region, expanding/adding to them where necessary.
  • To place more emphasis within each Balkan state on the preventative sector which involves screening and early, precision diagnosis.Again, more information and access for the public and patients is key. This should be done in a coordinated fashion in the Balkans where possible.

It requires the EU/European Commission:

  • To help facilitate and encourage the above plus IT infrastructure, interoperability and a common format for exchanging health data of all types (including EHRs) under strict ethical and privacy conditions.
  • To EU do more from a centralised point, (notwithstanding member state competence for health care) in encouraging member states to share more information on health from data banks, cooperate way-more effectively, and work to avoid research duplication (eg in HTA) and more.This is in line with its digital market strategy.
  •  To find optimum ways to integratpersonalised medicine into the EUs healthcare systems, facilitate the introduction of innovative pharmaceuticals and diagnostics, and build the necessary legal and regulatory frames.
  • At the same time there is a need to better address medicines’ issues, especially those of an ‘orphan’ nature from a cost (and therefore access) perspective. Medicines targeting rare diseases are by their nature usually only effective for a small cohort of patients. High prices of medicines is an issue that needs to be addressed EU-wide.


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