For European business, the
perils of the immediate past are being replaced by the promise of the future,
as the financial crisis appears to recede, and the prospect beckons of new
opportunities under a new European Parliament and a new European Commission.
The European Parliament elections this month will bring many fresh faces to
Brussels, and every lobby group in town is already planning how to win their
attention and hopefully their favour. Of even more significance, a new European
Commission is due to take office in November, replacing the timid and tired
ten-year administration of José Manuel Barroso with — it is hoped — a team
bursting with renewed dynamism and energy, and with a readiness to listen to
well-formed policy pitches.
It is against this background
that the principal drug industry associations in Europe launched a call in
mid-May for "an integrated European industrial policy for the
pharmaceuticals sector". The industry has achieved its own integration in
putting this plea together. It unites — in a rare show of unison — both the
European Federation of Pharmaceutical Industries and Associations and the
European Generic Medicines Association. The conflicting interests of the
research-based and generic companies have often kept them apart, but they have
started to work together much more closely in Europe, partly because of the
tougher conditions they all face, and partly because shifts in ownership and in
corporate strategy have blurred many of the distinctions that were so clear in
the past.
So now they are, as they say
themselves, "joining forces". They launched their appeal at the
annual EU Business Summit, taking advantage of its theme this year, “The
Business Agenda 2014–2019: Rebuilding a Competitive Agenda”. The drug industry
associations' particular angle is that Europe’s healthcare systems have
suffered from economic recession and austerity policies, and this has affected
access to healthcare for EU citizens. Their response is to urge promotion of
"an integrated life sciences industry for Europe" that will serve
both the health of society and economic prosperity.
The campaign that EFPIA and
EGA are conducting focuses on three priorities. First of all, they want a clear
recognition that medicines are essential to improve patient outcomes and equity
of access to healthcare across Europe. Then they want a more predictable
business environment so as to give the industry incentives to invest, to bring
"better and more cost effective treatments" to patients. And
alongside, they want a context that will "make the EU an attractive global
hub for pharmaceutical research and manufacturing."
These may all seem, at first
glance, to be reasonable, even laudable, objectives, unlikely to run into
opposition from anyone. But there is more to the campaign than meets the eye.
That first priority, of recognising the importance of medicines in European
healthcare, is not quite so obvious as it looks. There has been a rising tide
of concern in Europe about the role of medicines over recent year.
Part of this has sprung from
politics — perhaps, more aptly, from ideology. Distrust of industry in general,
and of the healthcare industry in particular, is every day more evident in
European public discourse. A long tradition of what started as rather lonely
dissent — going back to the days of Andrew Herxheimer and Charles Medawar in
the 1980s — has matured into organized opposition, now manifested in the
popular acclaim and high public profile that greets the Ben Goldsteins of
latter-day Europe. This has been compounded by a loose but increasingly
influential anti-science movement that ranges from the advocates of homeopathy
to the more muscular international civil society organisations capable of
mobilising thousands of supporters onto the street with a finely-phrased leaflet
on genetically modified crops.
As long as the negativism was
inspired by ideology, it was possible to contain and to counter. But the new
ingredient in the mix is the scepticism discernible among economists about the
merits of medicines in healthcare. Until recently, only zealots liked to draw
attention to the huge disparity between spending on prevention and spending on
medicines. Now it features routinely in official documents from national
treasury ministries and the EU Council of ministers of finance and economic
affairs. And it is never absent from any of the numerous governmental and
intergovernmental reflections on that new Holy Grail of sustainable healthcare
systems.
In other words, the old
certainties are no longer valid. While elimination of medicines entirely from
healthcare remains a view espoused only by the most radical, severe curtailment
of the spending on medicines in general is now common currency. The industry
that makes them is having to fight as never before against views that were,
until now, the preserve only of eccentrics.
The "predictable business
environment with incentives to invest" is just as challenging an
objective. It is hardly necessary to point to the current unpredictability of
the world economy and the still-fragile European recovery, and its obvious
implications for the feasibility of a predictable business environment. Much of
that, however, is in the lap of gods far more potent than those that stoop to
the concerns merely of the pharmaceutical industry.
But the aspiration for
incentives to invest does fall fully into the regulatory and economic arena
where health ministers, industry ministers, and economic affairs ministers hold
sway. And this is no easy terrain. The term "incentives to invest" is
just the latest variation on the theme that goes back decades — to the era of
the Bangemann round tables and before — when attempts were first being made at
European level to square that intractable circle of prices sufficient to fuel
the research cycle.
Indeed, as the costs of drug
development have soared, the terrain has become yet more difficult. New
treatments for hepatitis C, for cancer, or for multi-drug resistant
tuberculosis are emerging, but at prices that discourage healthcare paying
agencies from accepting their use. In turn, this discourages drug firms'
shareholders from entertaining the research programmes that can deliver
innovative treatments. And despite the all the heady recent talk of
risk-sharing and public-private partnerships, there is still little sign of
workable new business models that can offer the incentives being sought.
As to making the EU "an
attractive global hub for pharmaceutical research and manufacturing," the
scale of the challenge can be easily demonstrated by the recent avid interest
of Pfizer in AstraZeneca (because the EU is still an attractive global hub,
etc) and the alacrity with which drug firms are disengaging from Europe's more
troubled markets — and switching to Asia and Latin America. Conserving some of
the EU's member states as attractive hubs may be possible - although more
through national than European action — but trying to make the EU as a whole an
attractive hub is a venture certain to disappoint, and probably doomed to
failure.
Well might the generic
medicines industry boast — as it does in this joint pitch — that it is
investing in new manufacturing sites and increasing growth and jobs across
Europe. And well might EFPIA speak — as it does — of employing 700,000 people.
The claims are doubtless true. But if they demonstrate anything, it is the
industry's current prosperity. Not a recipe and not a justification for meeting
the challenges the industry says are so vital to its interests.
"With the EU elections
approaching, there is no time like the present to start talking with potential
leaders of tomorrow about how to pave the path towards a healthy EU in the
future,” concludes the industry announcement of its campaign. Start talking,
yes. But come up with some decent arguments if you want to win the debate.
Πηγή: PharmExec.com