This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click here.

Overview of the Key Changes to Regulatory Data Protection

One of the primary changes—and the focus of considerable debate—is the revision of the rules regarding regulatory data protection. The new Directive’s draft text devotes an entire chapter to regulatory data and market protection. You can read our initial article on the Commission’s proposal to change the rules on regulatory data protection for medicines here.

European Parliament’s Position

On April 10, 2024, the European Parliament adopted its position on the Commission’s proposal, amending the rules on regulatory data and market protection. Here are the key updates:

1. Standard Regulatory Data Protection Period of 7.5 Years, Subject to Extension

The regulatory data protection period is the timeframe during which applicants for a marketing authorization for new generic, hybrid, or biosimilar medicinal products cannot reference the dossier of an already authorized reference medicinal product.

• Current Directive 2001/83/EC: Fixed period of 8 years.
• Commission’s Proposal: Reduced to 6 years.
• Parliament’s Position: Increased to 7.5 years.

The base period may still be extended under certain conditions. The Parliament outlined these conditions as follows:

a). Addressing Unmet Medical Needs

If the marketing authorization applicant demonstrates that the medicinal product addresses an unmet medical need, an additional protection period can be granted. This applies if one of the therapeutic indications relates to a life-threatening or severely debilitating disease with high morbidity or mortality, and the product results in a meaningful reduction in these rates.

• Commission’s Proposal: Additional 6 months.
• Parliament’s Position: Extended to 12 months.

The Parliament also clarified that unmet medical needs should not influence pricing and reimbursement decisions and that “morbidity” should include factors like quality of life and patient experience data.

b). Comparative Clinical Trials

The Parliament maintained the additional 6 months of data protection for medicinal products containing a new active substance, supported by relevant and evidence-based comparator clinical trials as advised by the EMA.

c). Significant EU-Based Research and Development

A new rule grants an additional 6 months of data protection if a significant share of R&D has been conducted within the EU, particularly in collaboration with public entities like university hospitals or bioclusters.

d). Overall Cap

The Parliament fixes the overall cap on regulatory data protection at 8.5 years, eliminating the possibility of further extensions for making the product available in all Member States or obtaining authorization for additional therapeutic indications.

2. Standard Regulatory Market Protection of 2 Years, with Possible Extension

The Parliament retains the two-year period of regulatory market protection following the data protection period, during which a generic, hybrid, or biosimilar product cannot be marketed.

An additional 1-year market protection period can be obtained if authorization for an additional therapeutic indication is secured during the data protection period, replacing the Commission’s proposal for additional data protection in such cases.

3. Regulatory Data Protection Period of 4 Years for Repurposed Medicinal Products

The Parliament upheld the 4-year regulatory data protection period for repurposed medicinal products. This period is granted for new therapeutic indications not previously authorized in the EU and is independent of other data protection provisions. It can only be granted once per product.

For further details on the EU Parliament’s amendments and their potential impact on the pharmaceutical industry, stay tuned to our series on the EU pharmaceutical legislation reform.

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• EU Pharmaceutical Law Revision: Re-Boxing Set to Become the New Normal for Parallel Imports?
• EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Combating Antimicrobial Resistance