EU pharma legislation reforms inch closer to fruition

MEP and ENVI rapporteur Tiemo Wölken

MEP and ENVI rapporteur for the legislation, Tiemo Wölken

A key hurdle in front of the EU reforms to pharma legislation has fallen, after the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee approved a series of amendments to the original draft.

First tabled last year, the wide-ranging regulation has been criticised by the pharma industry, which claims it will have a detrimental effect on Europe’s competitiveness, as well as the life sciences sector and patient care.

Despite amendments designed to address some of industry’s concerns, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is still not happy, saying that, even though “pragmatic improvements” have been made, “the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines.”

A key element of the industry’s objections is a proposal to introduce a minimum regulatory data protection period for medicinal products, aiming to strike a balance between timely patient access and allowing developers to make a return on their R&D investment.

At the moment, the EU rules give developers eight years of data protection, during which others cannot access preclinical and clinical trial data, followed by two years of market exclusivity, during which generic or biosimilar products cannot enter the market. There’s also an extra year of protection for orphan drugs used to treat rare diseases.

The current draft voted on by ENVI sets a minimum data protection period of seven and a half years, with another two years of market exclusivity, during which generic or biosimilar products cannot be sold.

Developers can, however, extend that period – to a maximum of eight and a half years – if they satisfy certain conditions. That includes an extra 12 months for meeting an unmet medical need, and six months each if they conduct comparative trials with current drugs for the same indication or carry out the bulk of testing within the EU.

A one-time extension of 12 months on the two-year market protection period may be granted if a medicine is approved for an additional therapeutic indication that provides “significant clinical benefits in comparison with existing therapies,” according to the European Parliament.

In a nutshell, that means the base duration of protection for new medicines has been trimmed, but there are ways to extend it in some instances; for example, for orphan drugs used to treat rare diseases.

“It is hard to comprehend how reducing incentives for companies to discover, develop, and deliver new treatments in Europe is in the best interests of patients in the region,” said EFPIA director general Nathalie Moll.

“Under these proposals, we are highly likely to see companies continue to shift resources – research and development, clinical trials, advanced manufacturing, and scientific and academic skills – to areas with more ambitious life sciences strategies,” she warned.

MEP Tiemo Wölken, the ENVI rapporteur for the proposed regulation, said that the draft meets the objective of a “fairer, more accessible healthcare for all Europeans [with] measures improving access to medicines, whilst incentivising areas of unmet medical needs.”

MEPs are scheduled to debate and vote on the Parliament’s position during a plenary 10th-11th April. Progress will be delayed by the European elections 6th-9th June, but the new Parliament will then take the proposal forward.