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European pharma sector struggling to stay in front in changing policy context

Country : Germany, Israel

Keywords :
by Peter O'Donnell
BRUSSELS, 3 Apr (APM) - The European Health Coalition - of which EFPIA is a member - on Friday joined the chorus of calls for European "coordination" in the face of the Covid-19 pandemic and endorsed the concept of "a Europe that is able to foster accessible and affordable innovation for Covid-19".
Europe should be in a position to "find new diagnostics, treatments, medical technologies and vaccines", it says.
And it goes on: "Being prepared for future health threats to our continent and citizens means building a long-term research ecosystem and stimulating interdisciplinary synergies in Europe."
It advocates a Europe that "builds its own health future through an ambitious industrial healthcare strategy that will secure research, innovation, production and distribution of essential healthcare products and services".

Overtaken by events?

But this industry-inspired message comes at a time when the European policy framework is subject to many other - and often more pressing - influences.
As senior industry figures are increasingly admitting in public, the pandemic is changing the calculus on factors as significant as drug pricing and patents.
Paul Stoffels, chief scientific officer of J&J's Janssen, suggested on Thursday that a price of $10 a unit could be appropriate for a vaccine against the virus.
Gilead, facing a barrage of criticism for obtaining orphan status in the U.S. for its potential Covid-19 treatment remdesivir, dropped its claim, and said it "recognises the urgent public health need" (APMHE 66704).
AbbVie abandoned its patent rights on Kaletra when Israel granted a compulsory licence for its use against Covid-19.
The widely applauded readiness of companies to share data as they search for therapies and preventive agents also threatens to weaken the industry's long-held insistence on the sacrosanct nature of intellectual property protection.
The consequence of the pandemic is to raise the risk for the industry that its operating context will be shaped more by external circumstances than by its own attempts to drive policy.

Congruent, but no longer cutting-edge

Since the severity of the pandemic became evident, EPFIA has been energetically promoting its role in the response.
In February it insisted that "the biopharmaceutical industry in Europe remains committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks", listing the work of its member companies to fast-track collaborative research.
The federation has welcomed successive pandemic-related conclusions and decisions from the EU institutions. EFPIA director-general Nathalie Moll said in late March: "I have been heartened and encouraged by the level of collaboration and communication across industry, across the life-science sector, with regulators and the European institutions to tackle this crisis."
On 1 April, EFPIA published a series of commitments covering "industry's contribution to that collaborative, collective effort to tackle the coronavirus pandemic".
Its website has carried repeated pleas for collaboration among stakeholders and coordination at EU level.
But the industry protestations coincide with - and risk being submerged in - a growing tide of demands for even more far-reaching reform and review.
Cross-party MEPs made their views plain just days ago, demanding "new medical tools to be immediately available once authorised for use, at an affordable price and in high enough quantities to meet global demand". (APMHE 66730)
A global campaign by healthcare activists is calling for "immediate actions to declare that Gilead will not enforce and claim exclusive rights on patents and regulatory and trial data, or any other types of exclusivity anywhere in the world".
And there has been explicit support for limiting patents in Germany, Canada, Australia and Chile, with backing from WHO and UNITAID.

Policy hi-jacked?

The European Health Coalition is a broad-based amalgam of 34 organisations working on health, patients and the sustainability of healthcare systems, which grew partly out of Moll's ambition to engage the pharmaceutical industry in building wider partnerships - although she has denied to APM that it is an industry creation. (APMHE 60838)
The coalition has provided a platform for the sort of stakeholder debate that the industry wishes to promote, where it can discuss its agenda of innovation, investment and an appropriate intellectual property framework to promote R&D in a constructive or non-confrontational environment.
The statement it released on Friday - headlined 'Need for more solidarity and coordinated EU action to tackle Covid-19' - also conveys hope for improved health system performance, more action on prevention, health literacy, development of the proposed EU Health Data Space, and more equitable social and economic policies.
The pandemic has imparted growing impetus towards cooperation, but also towards radically critical attitudes to current patent and pricing regimes, perceived as hostile to public health interests.
The risk now perceived by some industry strategists who have spoken to APM is that the desire for cooperation may be fulfilled, but without delivering the associated recognition by other stakeholders of the merits of patents and paying for innovation.
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