ESIP responds to the evaluation roadmap-inception impact assessment

On 30 March the Commission launched the first stage of consultations with stakeholders towards the revision of the general pharmaceutical legislation, namely Directive 2001/83/EC1 and Regulation (EC) No 726/2004. ESIP submitted its first response to the evaluation roadmap-inception impact assessment touching upon several elements identified by the Commission to feed into future policy actions.

The evaluation is driven by the following objectives: ensure access to affordable medicines and address unmet medical needs; enable innovation for the development of high quality, safe, effective medicines, harnessing the benefits of digital technology and emerging science while reducing the environmental footprint; enhance the security of supply of medicines and address shortages; reduce regulatory burden and provide a flexible regulatory framework.

ESIP welcomes the forthcoming revision of the current legislative framework and provides its recommendations targeted to the following areas:

Unmet medical needs: ESIP calls to reach a common definition on ‘unmet medical needs’, based on quantifiable criteria and targeted to high unmet medical/public health/societal needs. Such definition should be cross-referenced in the EU legislation.

Simplification of the pharmaceutical legislation: When it comes to simplifying the EU pharmaceutical legislation, particularly to promote the swift market entry of generic and biosimilar, ESIP calls to fully preserve regulatory standards on quality, safety and efficacy and to limit fast-track approval procedures for new technologies to well-defined eligibility criteria. 

A new framework for incentives: ESIP supports the intention to update the existing framework for incentives, currently based on intellectual property rights. Alternative incentives models and mechanisms should be promoted and accelerate market entry of generics and biosimilars, e.g. through access to an effective repurposing framework. ESIP also supports the proposal to link incentives with conditionality clauses on making products available across EU countries within a restricted timeframe and ensuring transparency of R&D costs.

Fair Competition: In order to accelerate the entry to market of generics and biosimilars, ESIP suggests establishing a database of patents and SPC expiries, accessible to both public health authorities and generic and biosimilar manufacturers.

Adaptation of the legislation to innovations in the development and evidence-generation on health technologies: ESIP recalls that randomised controlled trials should remain the gold standard. Real-world data should be used as a source of complementary evidence, while payers’ evidence requirements should be considered from the outset.

Increased resilience of the supply chain: ESIP supports stronger obligations on transparency of stocks, early notification and supply and renews the call to introduce mandatory sanctions in case of non-compliance with the provisions set under Directive 2001/83/EC. 

The preliminary results of this evaluation will feed into the forthcoming impact assessment expected to run until the first quarter of 2022. A public consultation will follow later in 2021 and the legislative proposal is expected in the fourth quarter of 2022.

Find ESIP feedback here.