BRUSSELS, Feb 4 (APM) - The row over substituting Avastin (bevacizumab) for Lucentis (ranibizumab) in Italy in ophthalmology has been elevated to European Union level with the lodging of a complaint by three European pharmaceutical industry associations against Italian legislation promoting off-label prescribing.
The complaint was delivered on Jan 28 to the Secretariat General of the European Commission by lawyers working on behalf of the European Federation of Pharmaceutical Industries, EuropaBio and Eucope.
According to a copy of the complaint seen by APM, the industry associations allege multiple infringements of European Union law and significant damage to pharmaceutical innovation.
The contested measures were adopted by Italy in May 2014 and led the following month to the reimbursement listing of off-label use of Avastin for age-related macular degeneration - a condition for which the more expensive Lucentis is authorised.
The complaint says this use of Avastin “requires a reformulation of the product, which goes against the terms of the union marketing authorisation and renders it a new and unapproved medicine”. This undermines the EU marketing authorisation system and the protection of public health, say the complainants.
In particular, the complaint highlights the fact that “the measures are based on budgetary considerations that should never overrule the protection of public health”, citing EU rules that exclude exceptions to the marketing authorisation principle based on economic considerations.
The Italian law explicitly permits off-label use where a non-authorised indication “is known and in conformity with studies carried out within the national and international medical-scientific community, according to cost and suitability criteria”.
It also disregards companies’ rights to comment on a proposed listing, fails to provide sufficiently clear objective and verifiable criteria for the listing, and undermines the objective of encouraging research and development of new medicines, says the complaint.
The industry associations “request the European Commission to take action to ensure the termination of Italy’s failure to comply with its obligations under Union law”.
The complaint calls for urgent action because the infringements “go to the heart of the EU pharmaceutical regime”, and “risk being followed by similar actions in other member states, which would further undermine the EU pharmaceutical regime”.
It notes that a French law that allows off-label use to be officially endorsed - nominally in light of therapeutic considerations - is being supported by the minister of health, stressed on the grounds of budgetary considerations too.
“Similar practices occur more and more in other member states, through therapeutic recommendations or by setting budgets for specific medical procedures at levels that de facto impose off-label use of medicines or the use of unapproved medicines instead of authorised products,” it says.
In addition, urgency at EU level is necessary because a private legal action that has been started before the Italian courts “are expected to last for years”.
The EU should intervene because national litigation in different member states on similar measures may also result in contradictory decisions across the EU “on a matter that affects a core aspect of the EU pharmaceutical regime.”
The European consumers association, BEUC, told APM in a written statement of their “concern about the industry legal complaint”, particularly since “member states are really struggling to find a way to pay for very expensive new treatments”.
It said it fully supports the intention behind the Italian law - to promote the use of less expensive medicines for therapeutic indications where there is a real public health interest.
“In those cases like Avastin, where the company is not commercially interested in submitting an application, the national health authorities should intervene to protect overriding public health interests,” said BEUC.
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