Texts Show Details Of EU Parliament Transparency Directive Vote

The European Parliament last week overwhelmingly adopted a text on transparency that was said to improve conditions for generic medicines in the region. The voting documents are now available.

The 6 February vote record on the amendments is here and here.

Below is the information for the Parliament action on the Transparency Directive:

A7-0015/2013 Rapporteur : Parvanova Antonyia

• Committee on the Environment, Public Health and Food Safety (ENVI)

on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems

• Amendments
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• 001-059
• 060-064

• en

• en

Full recap is available on the oeil:

http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2012/0035(COD)&l=en

The consolidated text is available here: http://www.europarl.europa.eu/sed/votingResults.do

Generics Industry Welcomes Vote

The European Generic medicines Assocation (EGA) issued a press release welcoming the adopted text, which it said included several improvements for generics. These included: a shorter price and reimbursement approval time-limit for generic medicines; a ban on patent linkage, in which the “approval of price and reimbursement of generic and biosimilar medicines are linked to the patent status of the originator reference product”; and “the separation of competences between pricing and reimbursement and marketing authorisation authorities by not reassessing the elements on which the marketing authorisation has been granted (such as quality, safety, efficacy, bioequivalence, biosimilarity).”

The EGA said the directive is in line with the European Commission’s 2008 Pharmaceutical Sector Inquiry [pdf] that “had identified the key hurdles that block or delay generic medicines entry to the market and thereby compromise competition, savings and access to treatment for patients,” EGA said.