EU Legislative Reform

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.

Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.

The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.

Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels this month. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.

The revamped EU pharma legislation must be able to deal with current and future innovations in areas such as platform technologies and genome editing, the US biotech firm says.

Companies are already used to uncertainty and will be able to adapt to the new product launch requirement in the EU’s legislative overhaul for the pharmaceutical sector, according to a commission representative.

The IPO says some provisions in the EU pharma revision could contravene the TRIPS agreement, including plans to suspend regulatory data protection on products subject to a compulsory licence in times of health emergencies.

The European Commission’s pharmaceutical legislation overhaul could result in a loss of 50 expected new products by 2035 and an annual fall in R&D spending of €2bn, the European pharma industry federation EFPIA claims.

Emer Cooke told a European Parliament committee that she hoped the European Medicines Agency would be given sufficient resources to carry out its new tasks under the revision of the EU pharmaceutical legislation.

A former secretary of the US Department of Veterans Affairs and a senior Biogen executive deliberated at a recent summit the unintended consequences of the US Inflation Reduction Act and politics around the legislation. They likened the first prescription drugs subject to price controls under the IRA to a “TV commercial list.”