‘Baseline’ protection to be maintained in EU pharma law revamp

Catherine Drew of Pinsent Masons, who specialises in helping life sciences companies with intellectual property and regulatory matters, was commenting after the European Parliament and Council of Ministers reached provisional agreement on a package of proposed changes to EU pharmaceuticals laws, which are more than 20 years old.

The deal, which is still subject to endorsement and formal adoption by the two institutions, was reached after a lengthy period of scrutiny of the package. It is more than two and a half years since the European Commission outlined its original proposals for reform, motivated by the desire to improve – and speed up – patient access to new treatments while ensuring the environment within which the EU industry operates supports innovation and competition.

The package of reforms provided for is wide-ranging, but a central feature of it concerns the period of regulatory data protection that innovators can benefit from.

Regulatory data protection is one of a suite of measures provided for in EU law aimed at incentivising investment in drug research and development. The protection, which lasts for eight years from the point marketing authorisation is granted, precludes competitors from exploiting data the originators submitted to regulators, in the process of satisfying requirements for marketing authorisation, to develop their own products. A two-year market protection period provides a further period of exclusivity on top of the period of regulatory data protection, during which time generic medicines manufacturers can obtain a marketing authorisation but their products cannot be placed on the market.

Major changes to this current system of regulatory data protection were proposed by the Commission – it wanted to link the period of protection to the extent to which the product serves public health objectives – but, while details of the new deal struck are light, statements issued by the institutions suggest the new law, if implemented, will deliver more modest change in this area.

According to those statements, the default eight-year period of regulatory data protection will be maintained, but the further two-year market protection period will be revised down to one year – with scope for that to be extended if certain criteria are met.

“Pharmaceutical companies would be eligible for additional periods of market protection: if the particular product addresses an unmet medical need (12 months); if it contains a new active substance, fulfilling a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorisation within 90 days after the submission of the application for the first marketing authorisation outside the Union (12 months); if the company obtains an authorisation for one or more new therapeutic indications that bring a significant clinical benefit in comparison with existing therapies (12 months),” the Parliament said.

It confirmed that where products meet all three criteria, companies would only benefit from an additional two years of protection rather than all three years provided for. This is because the agreement provides for up to a maximum 11 years of combined regulatory protection in total.

A related change will impact manufacturers of so-called ‘orphan’ medicines – products earmarked for treating rare diseases. Orphan medicines currently benefit from a 10-year market exclusivity period, which applies from the point marketing authorisation has been granted. The Parliament said that, under the proposed new law, this will change to provide for “up to eleven years of market exclusivity”.

The package of reforms also seeks to incentivise greater investment in the development of new antibiotic treatments, amidst concerns about antimicrobial resistance. To this end, the deal reached provides for manufacturers of new antibiotics to obtain a “transferable data exclusivity voucher”, which they would be able to use to extend the regulatory data protection period by a year for one of their authorised products – though not “on products with annual gross sales of more than €490 million in the preceding four years”, the Council said.

A further change agreed on by the institutions will alter the existing so-called ‘Bolar’ exemption, which enables medicines manufacturers to use patented products when developing medicines for the purposes of obtaining marketing authorisation.

According to the Parliament, the revised exemption will allow generic manufacturers to make use of patents to conduct “necessary studies, trials and other activities … for the purposes of obtaining marketing authorisations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications”.

Anther change provided for in the package is new obligations on pharmaceutical companies to prepare plans to prevent medicines shortages, while the way the European Medicines Agency handles marketing authorisation requests will also be updated with a view to speeding up the process.

Drew said: “Maintaining the baseline regulatory data protection period at eight years is a welcome outcome. Originators had expressed concern about potential reductions, so retaining the status quo provides much-needed stability. At the same time, the clarification of Bolar’s scope and confirmation that submissions in procurement tenders are permissible is positive news for the generics sector. These measures will help accelerate access to lower-cost medicines, ultimately improving availability and affordability for patients.”

“This announcement is a further step towards companies in the space obtaining certainty. Pipelines are built many years ahead of product launch and assets are valued well ahead of medicinal products materialising and for these and many other reasons certainty as to the obligations, incentives and rewards of the pharmaceutical market in Europe is essential,” she added.