Comprehensive Reform of EU Pharmaceutical Legislation

EU Pharmaceutical Reform – Shift in exclusivity and the Clarified Bolar Exemption

The Council of the European Union and the European Parliament have reached a provisional agreement overhauling the pharmaceutical framework, after almost ten years of proposals and consideration. The changes are designed to stimulate innovation and accelerate access to generics and biosimilars.

The deal confirms an eight year period of regulatory data protection during which competitors cannot rely on the originator’s data, followed by only one further year of market protection during which generic and biosimilar products may not be placed on the market, resetting the default EU baseline at 8+1.
This represents a change from the existing position, which provides for two years of market protection. This structure is expressly framed to support innovation while facilitating earlier availability of follow on medicines once protection lapses.

Additional market protection is available in specific circumstances (described below), but critically the package imposes a cap on the combined regulatory protection at eleven years, constraining the total exclusivity overall. Pharmaceutical companies can benefit from additional 1-year periods of protection where:

• the product addresses an unmet medical need; or
• the product contains a new active substance, and the following conditions are met: (i) comparative trials are carried out; (ii) clinical trials are carried out in several EU Member States; and (iii) a marketing authorisation application is made in the EU within 90 days of any non-EU submission; or
• during the data protection period, approval is secured for one or more new therapeutic indications that deliver significant clinical benefit compared to existing therapies.

This expansion of the Bolar exemption promotes timely generic and biosimilar launch on day one of any regulatory and IP market protection expiry, whilst reducing the risk on manufacturers surrounding pre launch preparations.

Key takeaways

This EU pharmaceutical reform re-sets default exclusivity to 8 years of data protection plus 1 year of market protection, while introducing an absolute eleven-year cap that limits the cumulative effect of any add-ons. Limited one-year extensions are available for products addressing unmet medical need, for certain new active substances meeting comparative and multi-Member State trial and filing-timeliness conditions, and for significant-benefit new indications approved during the data protection period.

The reform expressly broadens the Bolar exemption as a targeted derogation from patent and SPC rights to cover the full spectrum of pre-launch readiness, enabling day-one competitive entry upon expiry of protection periods. Orphan exclusivity will also be recalibrated to a needs-based model (generally nine years, extendable to eleven for high unmet need, with “breakthrough orphan” pathways).

Overall, the package reflects a strategic shift from open-ended layering to calibrated, conditional exclusivity that ties rewards to demonstrable value while facilitating earlier, better-prepared generic and biosimilar launch.