The European Commission has given Italy two months to comply with European Union (EU) rules concerning the provision of marketing authorisations (MA) for generic drugs.
Italy's Intellectual Property Code contains an article which links the MA process to the intellectual property (IP) rights of the originator product, and this has led to lengthy delays in generic drugmakers’ ability to access the market, according to the European Generic medicines Association (EGA) and the Italian association of generic drug manufacturers, Assogenerici, which jointly lodged an official complaint with the Commission last year over the Italian situation.
Linking MAs for generic drugs to IP rights - known as "patent linkage" - is incorrect, say the trade associations, which point to the findings of the Commission's inquiry report into the pharmaceutical sector that the process is a clear abuse of the EU regulatory system.
In its formal request to Italy, the Commission tells it that its failure to respect the timeline for adopting the EU rules, set out in Directive 2001/83/EC, means that it is not providing adequate protection for generic drug manufacturers. In particular, it says, Italian law prevents them from submitting MA requests before the penultimate year of the reference product's patent lifetime.
“For example, if a patent on a reference product has a 10-year lifetime, manufacturers will need to wait at least nine years before they are allowed to submit their request for marketing authorisation. As a result of this law, and of the lengthy procedure to secure the authorisation for marketing, manufacturers of generic products are placed at a disadvantage on the market," says the Commission.
EGA and Assogenerici have welcomed this formal call for action. "We hope that this is the final step of the process and that very soon the patent linkage in the Italian Intellectual Property Code will be removed," said Greg Perry, director general of the EGA.
They also applaud the announcement by Italian Prime Minister Mario Monti, following the Commission's request, that steps will be taken to tackle patent linkage by removing the relevant provision - article 68(1-bis) - from the Code.
Assogenerici president Giorgio Foresti commented that, in laying down the foundations of Italy's economic recovery with the Liberalisation Decree, Mr Monti's government "has decided to include measures that expand the role of generic medicines, helping the Italian NHS to guarantee broader access to pharmaceutical care now and in the near future.”
"By removing the obstacle represented by article 68(1-bis), the government has not only responded to a specific request from [the Commission], but a new wave of competition is going to be injected into the market by getting rid of any patent linkage attempts," Mr Foresti added.
The trade groups are also calling for a provision to be added to the legislation which states that Italy's national medicines agency (AIFA) should not take into account any patent issue in the MA process.
'In this time of severe economic difficulty faced by European citizens and public health authorities, it is of crucial importance that patients can access affordable treatment with no unnecessary delays," said Mr Perry. "Delays in access to generic medicines were deemed unacceptable by the [Commission’s) pharmaceutical sector inquiry and the economic crisis makes such blocks as patent linkage totally unjustifiable," he added.
The request from Brussels to Italy to comply with the rules currently takes the form of a "reasoned opinion" under EU infringement proceedings. If Italy does not comply within the two-month deadline, the Commission may decide to refer the case to the European Court of Justice.