EU Legislative Reform

The EU’s regulatory reform package if unchanged could make orphan drug development less attractive, warn industry representatives.

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.

The proposed revision of the EU medicines legislation would retain the rules on safety monitoring and reporting much as they are at present, albeit with a few significant changes.

The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.

The European Commission’s draft regulation for reforming the EU medicines legislation has proposed a new product classification mechanism for borderline cases where it is not clear if a product is a medicine or falls under another area such as medical devices.

The temporary emergency marketing authorization, or TEMA, would be similar to the existing conditional approval while lasting only for the duration of the health crisis. But one law firm queries whether the new mechanism would be any faster in practice.

The draft Directive that was published last month with a draft Regulation for reforming the EU’s medicines legislation includes proposals for companies to publicly declare financial support received from a public authority or publicly funded body for R&D activities.

The European Commission says at least 65% of all human consumption of antibiotics should be of products that come under the World Health Organization’s AWaRe (Access, Watch, Reserve) classification, which have a lower risk of resistance.

Proposals for an EU voucher that would encourage the development of “game-changing” antimicrobials are accompanied by plans for procurement mechanisms to guarantee revenues for companies regardless of sales volumes. But one law firm said the conditions attached to the voucher were so strict that the scheme appeared “unworkable.”