Better access to health innovation is Kyriakides’ top priority (and hardest task)

The 63-years-old Cypriot is a clinical psychologist and a breast cancer campaigner. [EPA-EFE/SEEGER]

With increased powers, Health Commissioner-designate Stella Kyriakides is tasked with striking a difficult balance between making sure there is a steady supply of affordable medicines and ensuring that EU pharma industry remains a world leader in innovation.

Confirming rumours circulating in the past weeks, the 63-years-old Cypriot clinical psychologist is von der Leyen’s pick for the post left vacant by the Lithuanian Vytenis Andriukaitis.

She will have increased attributions compared to her predecessors, as she will oversee the regulation of medical devices and pharmaceuticals, previously under the competence of the Internal Market and Industry Commissioner Elżbieta Bieńkowska.

As stated clearly in her mission letter drafted by President-elect Ursula von der Leyen, she is expected to present a legislative proposal for a new regulatory framework on medical devices, with the aim of protecting patients and addressing new and emerging challenges.

In order to do so, the Unit GROW.D.4 dealing with medical devices will move from DG GROW to DG SANTE, as well as the Unit GROW.D.4 dealing with medical devices, a Commission document reveals.

However, her biggest focus should be on ensuring the supply of affordable medicines to meet Europe’s needs and at the same time on maintaining the status of a world leader in innovation for the European pharmaceutical industry.

Both issues are listed at the very top of her mission letter, reflecting Kyriakides twofold nature as a medical professional but also as a breast cancer patient herself. She headed Europa Donna, the first coalition of European breast cancer patients.

The other biggest issue of her mandate is the preparation of Europe’s Beating Cancer Plan, which is supposed to be a support tool for member states to improve national cancer prevention and care systems.

Hardest tasks

The understanding of patient-advocacy was hailed in a joint statement by the grouping of health NGOs European Public Health Alliance (EPHA) and the patients’ umbrella organisation, European Patients Forum (EPF).

The civil society organisations greeted the strong focus on delivering the United Nations Sustainable Development Goals (SDGs) for health but at the same time encouraged Kyriakides to take a more ambitious approach on antimicrobial resistance (AMR) and vaccination.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) also welcomed the commitment to look at ways to help ensure Europe has the supply of affordable medicines it needs, as well as the call to keep the European pharmaceutical industry at the top of the world when it comes to innovation.

“The President-elect’s Mission Letter highlights some key opportunities to deliver more for patients across Europe,” commented EFPIA director general Nathalie Moll, who considered the issue of medicines’ affordability a shared goal and responsibility of industry, healthcare systems and policy-makers.

However, the fine line between the need for pharma innovation, affordability and patients’ safety in practice proves hard to identify, as the heated debate over the Health Technology Assessments (HTA) proved in the past legislative term.

The discussion on this piece of legislation, aimed to help EU countries decide on pricing, showed that the assessment of new drugs’ added therapeutic value or innovation is becoming the thorniest problem in the sector.

Finding a balance between access to medicine and innovation promises to be her hardest task, considering that other priorities such as the e-health development, the commitment to the European One Health Action Plan, vaccines promotion, and even reducing dependency on pesticides are substantially in continuity with Andriukaitis’ mandate.

New drugs: how much are governments paying for innovation?

The European healthcare sector is divided over the “actual value” EU governments pay for the authorised and partly public-funded novel drugs, compared to medicines already on the market.

DG SANTE already at work

The nucleus of Kyriakides’ team for the next five years is already at work on these priorities, was informed.

On the very same day of her designation (10 September), the boss of DG SANTE, Anne Bucher, was invited to discuss the current pharmaceutical system and the major challenges the sector is facing with pharma policy directors from the EU member states, also highlighting activities the European Commission may undertake over the next few years.

The informal meeting was by invitation only, hosted by the current Finnish presidency and the Dutch permanent representation at the EU, and was intended to facilitate an exchange of ideas at a strategic level between top officials in the member states and the Commission.

Although the outcome of the meeting was not made public, it builds on the conclusions from Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council in June 2016, which called for a realignment of the EU pharmaceutical systems to better balance public and private interests, a Dutch source told EURACTIV.

A follow-up on pitfalls in the pharmaceutical market such as shortages and antibiotics and on medicines prices increasing beyond what is sustainable is expected to take place this December EPSCO Council, EURACTIV understands.

[Edited by Zoran Radosavljevic]

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