by Peter O'Donnell

BRUSSELS, 5 July (APM) - The new EU presidency's policy on "the economy of wellbeing" will be centre-stage on 8 July at its first formal Council meeting and the agenda contains some messages likely to jar on the drug industry, despite Finland's avowed attachment to innovation.

The so-called EPSCO council - covering employment, social policy, health and consumer affairs - will debate Finland's approach to integrating wellbeing into wider EU strategy with a new emphasis on coherence and breaking out of silo-thinking (APMMA 64464).

One of the key presentations at the meeting will claim that the EU's policy to medicines is failing to generate the right products and is sending drug bills sky-high.

A study that the presidency has commissioned for the meeting from the Organisation for Economic Cooperation and Development and seen by APM, notes "recent concerns about the output of the pharmaceutical innovation system and ensuring that novel drugs are affordable for both payers and patients."

It speaks of "important and met medical needs not adequately addressed by current investments in R&D", and contends that "prices of new drugs have been soaring", compromising patient access and straining healthcare budgets.

"The innovation model needs to be realigned to ensure that it delivers the right innovations, at the right prices and defines appropriate rewards," it concludes.

The study - which will be presented at the meeting by OECD secretary general Angel Gurria - also comments that while health technology assessment may yield life expectancy gains, it is "also likely to increase healthcare expenditure".

Ministers will also review - with a critical eye - progress by member states on targeting public spending in the social sphere, in the light of the EU's annual semester recommendations.

The draft conclusions that ministers are expected to sign off on are critical of persistent inequalities in health and other social provisions, despite repeated calls for reforms to widen access.

They note complaints from civil society representatives of insufficient focus on issues related to poverty and social exclusion and "affordable and sustainable health and long-term care services of good quality".

They also report dissatisfaction expressed by the EU's own social protection committee at delays in reforming national healthcare systems, including in bringing in "incentives for patients, physicians and pharmacists to limit pharmaceutical spending (and) measures to improve access for the most vulnerable e.g. to certain medicines and treatments".

"Despite the member states' efforts, progress in reforming the healthcare systems since June 2018 seems to have slowed down," according to the social protection committee.

Reforms are needed, the committee concludes, because "universal and sustainable healthcare systems with guaranteed access to timely, high quality and affordable healthcare are a key element of the European social model".

Health systems across the EU have to find solutions to the shared challenges of population ageing and "increasing costs of innovative technologies and medicines".

And Finland's own introductory paper for ministers says: "One of the greatest challenges facing the EU is the emerging inequality within the member states."

Innovation clearly has a place within the presidency ambitions, however, in line with its earlier statements, particularly about making progress with the EU's proposals for assessing new health technology (APMMA 64525).

At the informal meeting of EU ministers responsible for competitiveness in Helsinki on Thursday, Katri Kulmuni, Finland's minister of economic affairs, summarised the presidency's determination to promote strategies that would embed research and development in all EU policy-making and to help build an agenda for growth and new technology that would allow Europe to face up to global competition

And Finland's medicines agency, Fimea, has now fleshed out its own programme for the presidency, and this identifies as the top item "innovations and new medicines".

It is planning a meeting later in July with the EU Innovation Network which will break new ground in bringing together the European Medicines Agency's scientific advice working party, EUnetHTA, and the clinical trials facilitation and coordination group of the Heads of Medicines Agencies.

"These working groups will convene for the first time simultaneously," according to a Fimea announcement.

The meeting will review different groups' processes for scientific advice and map out "opportunities for collaboration, the scientific and regulatory challenges currently faced in the provision of advice, the horizon scanning of future challenges, the numerous ongoing development projects pursued by the authorities, and discussion on the demonstration of efficacy and safety in situations where such information is very limited upon issuance of a marketing authorisation, such as a conditional marketing authorisation".

It says its aim is "to promote more diverse discussion and information sharing about innovations and new medicines".

Dialogue and closer cooperation between medicinal authorities and HTA bodies are necessary if innovative medicines are to be made available to patients on a timely basis based on sufficient research evidence, it says.

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