BRUSSELS, 12 Oct (APM) - Opponents of the supplementary protection certificate waiver are exerting "disproportionate influence" on the EU Council of Ministers to effectively sabotage the proposal for easing limits on copy manufacturers, said the generics industry association, Medicines for Europe, in a Friday press statement.
comes while the European Parliament is still in the early days of its discussion of the European Commission proposal for the waiver - which would allow European manufacture of generics for export even before the expiry of a supplementary protection certificate (SPC) on the product being copied (APMHE 60106
There is a risk, says MFE, that the Council will 'neuter' the waiver, and give manufacturers outside the EU "a strong advantage over EU-based manufacturers".
"Vested interests continue to hamper progress on achieving a workable draft legislation," according to the generics association. "There is a concrete risk that disproportionate influence on the Council of the European Union will hamper the progress of an effective, usable SPC manufacturing waiver and maintain the status quo."
Medicines for Europe says it is urging member state governments and their health and industry ministers to withstand efforts to undermine it.
What vested interests?
MFE director general Adrian van den Hoven said: "Highly regressive revisions proposed by the Austrian presidency will only act against the objectives of the legislative proposal and delay EU generic and biosimilar medicines entering the market".
He called on EU legislators to "oppose any anti-competitive additions".
MFE has not responded to APM's request to identify the "vested interests" it is attacking, nor to specify which Austrian proposals it objects to.
But the accusation is clearly an indirect criticism of lobbying by the research-based sector in Europe, which has been fiercely opposed to the SPC waiver since it was first proposed.
When the proposal emerged in May, EFPIA greeted it with "deep concern", criticising a negative signal on intellectual property rights and a threat to innovation, investment and jobs. (APMHE 58267
MFE's statement says only: "Unfortunately, it is becoming increasingly clear that vested interests are exerting pressure on policymakers in the Council to remove clauses or add new ones that will jeopardise the whole legislation in an attempt to limit competition in unprotected markets at the expense of European competitiveness and growth".
It claims that weakening the waiver "will lead to a loss of jobs opportunities for the EU pharmaceutical industry versus international manufacturers and increase pressure on member states’ medicines budgets".
EFPIA has not responded to APM's request for comment on whether it considers its lobbying is in any way illegitimate.
What MFE wants
MFE wants the SPC proposal toughened up rather than watered down.
It says the European Commission's proposal was itself a dilution of what was needed, since it did not make sufficient provision for generic firms to prepare for launch in the EU immediately on SPC expiry.
Top of the MFE wishlist is for generic manufacturers to be allowed to stockpile products for the EU in advance of SPC expiry.
It also wants the removal of related requirements for notification of the intention to use the SPC waiver, which have "a significant dissuasive effect… making the legislation effectively useless".
Immediate application of the waiver to existing SPCs is another MFE ambition. The Commission proposal envisages its application only to new SPCs; MFE says this will "negate the opportunities presented by the next significant patent cliff as of 2020."