by Peter O'Donnell
BRUSSELS, 30 Nov (APM) - The proposed easing of limits on generic copying of medicines has still won only limited support among EU member states, it became clear during the meeting of the Competitive Council in Brussels on Thursday.
Since July, the Austrian presidency of the council has led five preparatory discussions among diplomats of the Commission's proposal to allow generic exports a waiver to supplementary certificate of protection rights.
It has submitted three successive compromise texts.
But ministers still expressed widely differing views on the way ahead when they formally discussed the latest draft compromise.
According to the presidency, its compromise texts "met with a large amount of support among delegations, but a few important issues are still unresolved."
Exports OK?
The latest Austrian compromise text largely reflects the Commission's proposal, in its acceptance that the SPC can have a negative impact on EU-based manufacturers of generics and biosimilars, since during its term they cannot manufacture their products for export to countries where SPC protection has expired or does not exist.The justification is that easing the protection would create a level playing field between EU-based manufacturers and their competitors in countries where SPC protection does not exist - notably Brazil, Russia, India and China.
No stockpiling?
However, Austria's compromise excludes any stockpiling in advance of the expiry of the SPC - a flat rejection of one of the key asks of the generic sector, which wants to extend the scope of the measure so that EU companies can prepare to launch a copy in the EU on the first day the SPC is no longer in force."Our compromise is that the waiver will apply only for products for export," said Margarete Schramböck, Austrian Federal Minister for Digital and Economic Affairs.
Elżbieta Bieńkowska, the European Commissioner responsible for industry affairs, said she was grateful for the presidency's efforts and its support for the proposal.
"Now, with only two issues outstanding, on scope and on timing, we must show flexibility," she said, urging rapid progress among officials so that senior diplomats can look at the issue again before the end of the year and prepare for discussions with the Parliament, which is due to finalise its position early in 2019.
Diverging national views
Countries with a strong national research-based industry tended to express caution over the proposal during the council meeting.Sweden emphasised the importance of protecting research and said it was "not convinced of the merits of any SPC waiver".
Denmark saw the risk of "a negative impact on the innovative life-science industry", including in terms of competition for EU firms' originator products in export markets.
It said that the current legislation is already appropriate, and that it would be ready to consider easing the rules only for applications for a waiver as from a date in the future.
Germany described the current text as "a tricky balance not quite there", identifying problems over the provisions for obligatory notification of the intention to copy, the timeline for implementation and the safeguards to prevent re-import of exported products.
But "We're ready to continue being constructive," indicated the German delegation.
Support for rapid progress
On the other hand, Bulgaria said the Austrian text is "good for generics and good for European competitiveness".Spain, Lithuania, Slovenia and Slovakia were in favour of easing protection - including because of the need to protect jobs in the EU generic sector, and said they wanted to see fast progress.
Hungary argued that the proposal "offers a remedy to imbalances that hinder generic companies", and that it could end "negative discrimination" that, in its view, harms taxpayers and patients.
For Portugal, the compromise would offset the disadvantage of EU generic firms on the global stage, and as such is a good balance between the interests of citizens and those of research.
Cyprus too supports the waiver, as does Poland, which stressed the urgency of completing the legislation before the end of the term of the current European Parliament next spring, so that it could come into effect by 2020, or at the latest 2022.
Halfway there
In a sort of middle ground, Ireland indicated it was satisfied with a waiver just for exports, as did Belgium - which underlined that these should be to countries with no SPC.Malta said it was ready to back the compromise as long as there was no stockpiling and no retroactive application.
The UK too said it was necessary to maintain the balance in the Commission proposal on the scope of the measure.
The Czech Republic added its voice of concern about a "negative impact on originators" in reducing legal protection "in favour of one interest group to the detriment of Europe's health".
It would be prepared to consider a waiver for exports only if the destinations were developing or less developed countries.
At the end of the meeting, Bieńkowska said she was "encouraged" by the outcome and hopeful of moving ahead rapidly.
Sergio Napolitano, Legal & External Relations Director at Medicines for Europe, told APM the meeting "showed a very broad political support to the introduction of an SPC manufacturing waiver and a clear political will to reach an agreement within the Council before the end of the year."
"While certain technical points remain to be agreed, we appreciate the general positive approach," he said.
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