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.
Rule changes mulled
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