EU rules on generic pricing could be delayed until 2016
A revised European transparency directive containing rules requiring generic pricing and reimbursement decisions within 30 days could be delayed until 2016 because of resistance from two member states, a conference heard on Thursday.
The European Generic Medicines Association (EGA) conference in Malta heard the current draft contains rules replacing a previous deadline of 180 days in the original 20 year-old directive.
Salvatore D'Acunto, head of the food and healthcare biotechnologies unit at the DG Enterprise and Industry, added the draft proposed in March also outlaws patent linkage, when originator companies block generic launches using intellectual property laws.
If no decision has been taken within 90 days, member states will have to pay the price originally proposed by the applicant.
In cases of serious infringements, member states may be asked to pay damages and in extreme, cases could face daily fines for failing to comply.
The proposed law will also apply to regional authorities that make pricing and reimbursement decisions in countries with more devolved arrangements such as Italy, said D'Acunto.
However D'Acunto said that challenges to the legislation by Austria and Luxembourg are likely to delay adoption of the directive until late 2014 at the most optimistic and 2016 if negotiations do not go to plan.
The two member states are particularly resistant to the proposed enforcement measures and argue that in the current draft, the commission is acting beyond its powers, said D'Acunto.
He said: "Member states are not responding positively to this. But the measures might make authorities respect the deadlines and become more proactive."
Numbers of pricing and reimbursement decisions will be monitored every six months, along with numbers of deadline breaches, under the current draft.
D'Acunto added: "The image is that this proposal is made in the interests of industry. It is not only made for that. It is also made for the patients and to reduce national budgets.
"Talks will take time. It is inevitable that there will be some resistance in some member states. Some are totally in line but there are others who are less inclined to accept this."
However D'Acunto said that he is confident that the European Parliament will accept the proposals.
Speaking to APM on the sidelines of the conference, Greg Perry, director general of the EGA, said: "We really welcome the proposals. It is not just about industry, it is about getting affordable medicines to patients more quickly.
"We only have two states opposing, not the 55% needed to block a proposal. We will have to reach out and explain to them that preventing patent linkage does not just protect industry but also protects health authorities.
"There have been instances where health authorities have been litigated by the patent holders too. But we will work it out," Perry added.