"EU reforms in the pharmaceutical sector - a pivotal year of change ahead " provides an analysis of the major reforms lying ahead under the EU Pharmaceutical Strategy and IP Action Plan. These include the proposed scaling back and conditionality of regulatory exclusivities granted to new medicines, whereby the period of standard data protection would be reduced from eight years to six unless the product meets an unmet medical need or is marketed across the EU within two years of receiving authorization (both representing restrictively high thresholds). Similarly, for orphan drugs, the fixed 10-year market exclusivity period may be replaced with a variable-duration exclusivity period calculated based on the characteristics of the medicines.
We also address the Commission's harmonisation efforts regarding compulsory licensing and supplementary protection regimes. Importantly, these changes are further discussed against the broader context of increased scrutiny from competition authorities, as seen by the recent wave of investigations into alleged abuses of the patent system by pharmaceutical companies.
Our article showcases the importance of assembling multidisciplinary teams, drawing from IP, regulatory, commercial, and competition expertise to best prepare for, and to mitigate risks from, a new political and legal environment. We hope you find it helpful in highlighting some of the key headlines of the far reaching changes approaching.