EU Legislative Reform

The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.

Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.

The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.

The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.

Faster regulatory reviews proposed in the European Commission’s pharmaceutical reform package could impact the EU-level joint clinical assessments that go live from 2025.

The European Commission’s proposals for legislative reform in the pharmaceutical sector are welcome but must go further to address patient and societal needs, says a coalition of five EU countries dedicated to improving access to medicines.

The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.

Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.

Proposed revisions to the EU pharmaceutical legislation should do more to deliver a better data and research infrastructure to help propel European drug development and better clinical research, says IQWiG, Germany’s health technology assessment institute.

IQWiG, Germany’s health technology assessment (HTA) body, is calling for EU legislative reforms to do more to promote better evidence that addresses the questions health systems and HTAs have about the added benefits of new medicines.

The European pharma industry group fears planned cuts in regulatory data protection and orphan drug exclusivity periods will hit innovation but says it is ready to work with legislators to close what it sees as an R&D gap between the EU on the one hand and the US and Asia on the other.

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.