EU Legislative Reform

In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.

A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.

One of the key challenges facing the Hungarian presidency of the Council of the EU in the second half of 2024 will be the proposals for an overhaul of the EU pharmaceutical legislation, which were amended by the European parliament in April. In the latest in a series of articles on progress with the reform, the Pink Sheet examines the issues surrounding the hospital exemption for advanced therapies.

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.

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.

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. 

In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.

The European Commission’s proposed revision to the EU pharmaceutical legislation has taken another step forward after the European Parliament adopted its position on the draft text, which includes a seven and a half year baseline regulatory data protection period.

Members of the European Parliament have significantly watered down plans for a cut to regulatory data protection, but industry says the net effect of the proposals will still be to make Europe “less competitive and less attractive” to investment in innovation.

Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.

Nathalie Moll says that the European Commission’s estimates of the costs to EU member states of regulatory data protection are “incorrect and over-estimated.”

All eyes will be on the European Parliament’s ENVI committee later this month when it votes on the planned overhaul of the EU pharmaceutical legislative framework, including a highly controversial proposal to cut regulatory data protection for originator drugs.

The EU pharmaceutical revision package includes proposals that will have a direct impact on smaller firms, including a targeted regulatory and procedural support scheme.