In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.

Pharma companies seeking a subscription-style contract for new antimicrobials will need to meet a number of requirements, such as guaranteeing surety of supply, meeting key performance measures and complying with specified manufacturing standards.

A co-chair of the Intergovernmental Negotiating Body says that whatever happens over the coming fortnight, a report on the outcome of the talks will be delivered to the World Health Assembly at the end of this month.

Under the new scheme, contract payments for antimicrobial products of up to £20m a year will be based on clinical award criteria with a points-based scoring system derived from experience with the pilot scheme.  

In the second in a series of articles on amendments to the EU pharmaceutical reform proposals, the Pink Sheet looks at changes made by the European Parliament to the “transferable exclusivity voucher” and its ideas for a milestone payment and subscription-model scheme. 

The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.