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The plan to accelerate generic pricing and reimbursement has become another tragic European casualty.
Another of those anniversaries in European pharmaceutical regulation has slipped by unobtrusively. It is just a year ago that bold intentions were almost agreed for speeding up the pricing and reimbursement of generic medicines. An outline consensus was reached within most of the European Union's key institutions that the timelines for getting generics onto the market were too long, because there was too much discussion over what they should cost and who should pay for them.
So, instead of the six months that the EU's legislation allowed for, EU officials and the European Parliament took the view that a month should be enough for member states to reach a decision on an application to fix a price for a generic, and a maximum of a month for deciding on whether it could be reimbursed too. It was the culmination of an extensive debate that had featured some striking statistics and some energetic lobbying.
Research by officials in the European Commission had suggested that it was taking an average of more than seven months for generic medicines to reach the market after the originators lost their exclusivity, and that pricing and reimbursement rules were a factor in that delay. The European Generic Medicines Association (EGA) said its members were waiting an average of 153 days after marketing authorization to receive pricing and reimbursement status, and the range across the EU's member states ran from as little as 14 days to more than 270 days.
In the European Parliament, the influential figure of Antonyia Parvanova insisted that shortening timelines for generic medicines was a key element in the financial sustainability of national healthcare systems. European industry commissioner Antonio Tajani, who launched the proposal to update the EU's 20-year-old rules, said EU member states would benefit from the savings resulting from faster access to generic drugs, and industry and patients would benefit from cutting through some of the red tape currently holding up decision-making. His aides predicted that reducing the time lag would also stimulate price competition, bringing further savings — because originator prices in Europe drop by an average of 20% during the first year after generic entry and 25% in the second year — and by as much as 80-90% in some cases.
Why, demanded the advocates of change, was it possible for some countries to complete the entire process in a couple of weeks while others needed the best part of a year? Administrative complacency, they alleged — arguing that without introducing specific shorter timeframes for generics, national authorities would continue treating these products within the more generous schedule designed for the more complex process of considering pricing and reimbursement applications for new medicines. It was just an accident of history, they said, that there was no legislative provision for fast-tracking these decisions; back in the 1980s, when the current EU rules were agreed, generics represented only a tiny proportion of the EU — whereas today they account for some 50% in volume. That damage from that accident should be repaired, they urged, with new rules.
The Commission, therefore, proposed obliging member states to make their decisions within 15 days of an application. It was even ready to consider the introduction of national provisions granting automatic/immediate reimbursement status to generic medicinal products where the corresponding originator already benefits from reimbursement at a higher price — something that roughly 80% of the generic industry had recommended in consultations on the new legislation.
And the parliament broadly agreed. It reinforced the Commission's proposal with a call for "accelerating the entry into the market of generic medicinal products," and beefed up proposed provisions relating to circumventing intellectual property issues. These "should neither interfere with nor delay pricing and procedures for reimbursement of generic medicines in the member states," said Members of the European Parliament (MEPs). The parliament also saw the merit of cutting the timing, although it took a slightly more cautious approach, calling for a more leisurely 30-day deadline — something that was still within an acceptable timeframe for many in the generic industry.
In fact, the EGA hailed the parliament's vote last February as a triumph, noting that "MEPs have given a positive impulse" to updating the rules (confusingly known as the "transparency directive"). It praised MEPs' support for the introduction of a shorter price and reimbursement approval time limit for generic medicines, and for banning unnecessary complications relating to intellectual property protection or to quality, safety, and bioequivalence.
"European generic medicines manufacturers are pleased that the European Parliament has correctly tackled unjustified delays and market distortions for generic and biosimilar medicines," said Beata Stepniewska, EGA's acting director general at the time.
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 EU legislation.
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 and Efferalgan.
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 health systems.
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.