A draft of the European Commission’s ongoing review of pharmaceutical legislation has leaked, prompting a bitterly-worded reaction from drugmakers, which accuse legislators of “sabotaging” the industry.
There is no doubt that the proposals represent serious change.
Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin, describes them as the most far-reaching for decades.
On this week’s episode of The Pharma Letter Podcast, Mr Meulenbelt will walk us through the leaked draft and outline the most significant impacts, good and bad.
Some of the measures to be considered include: generally shorter periods of exclusivity for novel medicines; a requirement that new drugs must launch region–wide within two years; and the introduction of a voucher system to encourage the development of new antibiotics.
The European Commission is also apparently proposing to simplify the drug application process, increase obligations on drugmakers to report shortages and bring in more foreign inspections.
Of course, whatever the final proposals turn out to be when they are published at the end of April, they will likely change again, with the European Parliament and the EU Council next in line to debate and revise the document.
No doubt, there will be plenty of chances for the industry to have its say before then.