Resistance stalls action
So why has the anniversary slipped by without much remark? Why were the bold intentions only "almost agreed," and why was
outline consensus reached only "within most" of the EU institutions? Because even though the Commission and the parliament
were closely aligned, the three-legged stool of EU rules was missing one leg — the Council, where the 28 member states make
their decisions. Without the national governments on board, this legislation could go nowhere. And national governments were
not — and still are not — on board.
Part of the resistance in the Council came from member states' concerns about being forced to work more quickly. Granting
pricing and reimbursement status to generic products automatically or immediately where decisions have been made on the corresponding
originator just hasn't caught on — Spain is one of only a handful of member states to have toyed with the idea. Most of the
others have no desire to amend the rules so as to shorten the time limits for the pricing and reimbursement of generics. During
the consultation process on the proposal, half of the national authorities and public health insurance bodies that responded
took the view that the current time limit of 180 days should be maintained for generic medicines. They say that changes to
their current procedures would entail a significant additional burden. As the Commission has laconically observed, "these
positions indicate that a reduction of processing times for generic medicines is unlikely to happen across the EU at the sole
initiative of member states."
Part of the resistance comes from another direction, more political than technical. The member states just don't want the
EU getting too close to their own privileges and rights in deciding on how they handle drug pricing and reimbursement — a
reflection of long-standing (and in these more eurosceptic days, a frequently more pronounced) tension at the heart of all
The Commission itself has remarked on the apparent paradox that some countries that already make decisions in 30 days or less
for generics are still opposed to legislation on shorter timelines, for instance, Sweden and the UK.
But the paradox is only apparent: both these countries have a strong streak of pragmatic independence, with no enthusiasm
for (and indeed a palpable reluctance about) legislation for the sake of legislation. Although EGA's Stepniewska said a year
ago that her organization "is looking forward to a swift follow-up of the legislative process and constructive dialogue with
the institutions," she hasn't had it.
To all intents and purposes, the bid to update the transparency directive is dead in the water, and all those pious expectations
of change in the parliament or the Commission are no more than vain hopes. The initial proposal emerged during the Danish
presidency of the EU — and that most famous Dane of them all, who was from Elsinore, might have had the transparency directive
update in mind when he said, "Thus conscience doth make cowards of us all, and thus the native hue of resolution is sicklied
o'er with the pale cast of thought. Enterprises of great pith and moment with this regard their currents turn awry, and lose
the name of action."
Instead, the action, such as it is, in relation to generics has moved away from European pricing rules to European competition
rules, and in many respects away from European rules altogether, and back to national rules. The impact of EU competition
rules has been seen in the fines imposed over recent months on companies found to have breached anti-trust law in pay-for-delay
agreements to keep generics off the market. And the shift to national action on generics is graphically demonstrated by the
more limited geographical scope of recent key events.
In France, the authorities imposed a $20 million fine in December on Merck & Co. subsidiary Schering-Plough for attempting
to block a rival generic version of its Subutex through systematic denigration; and Sanofi was levied a €50 million fine last
May for similar behavior to protect its antiplatelet Plavix. At the same time, Sanofi is fighting a valiant rearguard campaign
to limit the damage from the French government's determination to push through generic substitution and price cuts on high-consumption
products such as acetaminophen — the active substance in Sanofi's top-selling Doliprane and Bristol-Myers Squibb's Dafalgan
Meanwhile, in Germany the latest debate is on whether generics should be exempted from drug price controls — not European
controls, but German controls. In Spain, the arguments center on the fact that half of the drugs sold in the country cost
only $5 or less, while a new report in Italy argues that it is generics that are keeping the reimbursement bill in check —
not in Europe, but in Italy. And, as they say in Europe, "ainsi de suite" — the same trend to a national focus in discussions
of generics is visible across the member states. At the same time, the rhetoric of the EGA has moved away — as if in reluctant
recognition of the inevitable — from urging faster pricing decisions to more general engagement in the debate about sustainable
By January, Stepniewska's narrative had moved on to how the generic industry should "seize on opportunities in the current
period of austerity to amend its way of thinking and push for significant changes to the regulatory environment." None of
the changes she highlighted related to faster reimbursement decisions. As Hamlet himself commented, "The rest is silence.
Reflector is Pharmaceutical Executive's correspondent in Brussels.