#EAPM – The personalised touch: Interview with chair of #BAPPM board

| October 11, 2018

At the end of June 2018, Bulgaria wrapped up its first-ever Presidency of the EU during which, among many other matters, its Council Conclusions called on Europe to continue prioritizing public health, “in particular by addressing issues of cross-border importance”, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

It also called on the EU to strengthen synergies in Horizon 2020 projects among all relevant sectors, and “explore all possibilities for continuing to support member states’ policies and initiatives in the framework of existing instruments at EU level, such as the Third Programme for action in the field of public health…and to ensure sustainable mechanisms in the future focused on the need to invest in people”.

During and after the presidency, Sofia hosted conferences dealing directly with the health sector and one such is imminent this month, this one focused on the ongoing debate surround the European Commission’s plans for EU-wide health technology assessment (HTA).

The conference is entitled:’Is HTA for Personalised Medicine Products Personalised?’  The Bulgarian Alliance for Precision and Personalised Medicine(BAPPM), will be the host and obviously a key player at the event on 12-13 October.

In advance of that, we put a few questions to BAPPM’s chair of the board, Jasmina Koeva-Balabanova (pictured):

EAPM: Jasmina, how do you feel about Bulgaria’s first presidency?

Jasmina: The presidency went very well, and we are all proud of our country’s time in the hot seat. I’m particularly proud of the health elements, not least in respect of children, diets, etcetera, in the Council Conclusions which emerged at the end of June.

Now we move on and, as you know, Bulgaria signed up to the joint declaration on the MEGA project – to put together a cohort of at least one-million genomes across the EU by 2022 and I would like to thank to the Minister of Education and Science, Krasimir Valchev and his political cabinet, who supported the project and made Bulgaria part of it – and we are now dealing directly with the current hot topic, which is joint action on HTA.  This has seen some resistance from certain member states, not surprisingly as competence in health is closely guarded by every country. Yet we have to learn to cooperate to get the best for all our patients.

EAPM: So, the upcoming conference…

Jasmina: The conference in our capital will present and discuss the specifics of HTA in respect of personalised medicine products as well as target therapies, companion diagnostics, and innovative pharmaceutical products for personalised treatment.

The discussion will feature the views of representatives of the European Commission, working groups for HTA and many more including industry representatives, professors, students and postgraduates from health faculties.

Improving HTA and strengthening cooperation across countries promises to provide better estimates of the medical and social value of new therapies and medicines.

We expect lively debates at the event, which will cover various sectors of HTA, including current trends and development, principles and practice, specific requirements on necessary information, unsolved issues and consequences from inappropriate methodologies, plus the sharing of good practices.  Also on the agenda are HTA in rare diseases, IVD and companion diagnostics, while a hot topic will be the role of HTA for better patient access to personalised medicine.

As you know, even given the favourable European Parliament vote, there was nevertheless an acknowledgement that opportunities to improve HTA quality are currently being missed, and we feel that the legislation is short on providing for adequate patient participation in the EU-HTA cooperation framework.

EAPM: Can patients play a bigger part, then?

Jasmina: Of course! Patients have unique knowledge, perspectives and experiences, and are the ultimate beneficiaries of medical technologies.     Therefore, patient representation is essential at all levels of decision-making when legislation directly affects their health and lives.

Not only that, patients need to be at the centre of their own healthcare, sharing decisions and forward-moving actions with their doctors. It’s a two-way street, or certainly should be, especially in these times when science and technologies are moving fast and the role of lifestyle is being recognised, certainly in personalised medicine.

For example, in Bulgaria today, one-in-10 patients are treated with innovative therapy, with some 2,000 receiving personalised treatments.

At the moment, almost all approved by EMA target therapies are registered in Bulgaria, but due to various reasons, according to ArPharm, patients have access to around 30% of them, with 70% of all registered drugs for personalised treatment and 100% of target therapies in oncology reimbursed by the National Health insurance fund. And there are currently 41 registered products for personalised therapy, including 31 in the field of oncology.

It’s a happy statistic that Bulgaria ranks third in EU Member States’ investment for the testing of innovative treatments, with investments in clinical trials accounting for around €225 million. Not bad given that we are one of the smaller EU nations, with around 7.3 million people.

Also, Bulgaria is currently developing Centers of Competence in Personalised Medicine in Medical University Plovdiv, Medical University Pleven and Medical University Varna , which are co-financed by the EU. The first one has access to some €12 million and was launched in March this year, The second is planned for 6 years period.

EAPM: This is all great, but is there a down side?

Jasmine: Yes, unfortunately it is a fact that Bulgaria is ranked pretty low with regard to the quality of its health services.

More than 50% patients out-of-the pocket payments is the highest in the EU with direct payments from patients three times higher than the European Union average.

Meanwhile, the comparative analysis of innovations in the EU for 2017 had Bulgaria ahead only of Romania. And the World Index for Innovations of Cornell University and INSEAD has found that Bulgaria ranks 36th from 127 countries.

That last statistic isn’t so bad, but generally there are obviously grounds for improvement.

EAPM: How can the EU’s smaller member states help to push the agenda in personalised medicine?

Jasmina: Historically, smaller states have been active in shaping health policy at European level and can now act as vital policy entrepreneurs pursuing normative policy agendas.

Prior to the 2004 ‘big bang’, when ten new states joined the EU, smaller countries had little choice but to accept an acquis communautaire that often failed to take into account their individual aspects and characteristics.

Since then, smaller countries have been active in shaping health policy at European level. Meanwhile, co-operation in areas such as health technology assessments are likely to receive more support from these countries, which often rely heavily on networking and capacity building. This has been shown given our views on the Commission’s HTA proposals.

And regarding the EU presidencies, smaller member state influence has been demonstrated by, for example, Slovenia and its major role in promoting cancer policy development at EU level.

We have also recently had Latvia, Luxembourg – with its landmark conclusions on personalised medicine – Slovenia and The Netherlands at the helm, plus ourselves, Malta and the current president Austria. Romania and then Finland are next up. Added together, that’s a lot of citizens!

EAPM: How can the EU help?

Jasmina: Well, for a start, it’s clear that Europe’s health policies need to recognize and tackle the inherent health system vulnerabilities faced specifically by smaller countries, and in the regions of the larger ones.     Many challenges remain for the smaller states, especially in the health arena, and these include a lack of interest by industry to place medical goods on such small markets due to high or inefficient unit costs of production, and a lack of competition between providers, which means high prices for medicines and medical supplies due to small volumes of consumption.

Meanwhile, the administrative burden of regulation does little to help patient access and lower prices in these countries.

To answer your question, European health policy needs to become better attuned to the specific challenges facing the health systems in smaller states and regions, not least patient access to the best treatments available and the need for more and better research.

BAPPM is working hard to fight for access and innovation in health care and our HTA conference is one part of that.

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