[co-author: Maria Chaita]

The European Medicines Agency (“EMA”) has sought to support Small and Medium-sized Enterprises (SMEs). As part of this effort, the EMA has launched a new Action Plan to address the challenges that confront SMEs and their stakeholders. In particular the Action plan addressed challenges to SMEs regarding the funding and cost related to regulatory actions. The Action Plan includes the actions that should be taken before 2020 to enhance and support SMEs. As SMEs importantly support the development of medicinal products, the ultimate goal of the Action Plan is to support innovation in the field of human and veterinary medicines.

Background

The Commission Regulation (EC) No 2049/2005 concerning the rules regarding the payment of fees to, and the receipt of administrative assistance from, the EMA by micro, small and medium-sized enterprises (“SMEs Regulation”) was adopted in 2005.

Ten years after the adoption of the SMEs Regulation, EMA hosted a roundtable meeting with SMEs stakeholders in order to evaluate and provide an updated overview of the EMA’s initiative to support SMEs.

In 2017, EMA developed the Action Plan, based on the feedback provided by SMEs’ stakeholders consultations and on its current initiatives concerning the support for innovation.

Action Plan

The purpose of the Action Plan is to assist in the development of SMEs, and to foster innovation. Furthermore, the Action Plan aims to create a favourable ground for investments.

In particular the Action Plan focuses on the following four major themes:

• “Raising awareness of the EMA SME initiative to stakeholders in the innovation lifecycle;

• Developing regulatory knowledge base of SMEs in the pharmaceutical sector;

• Fostering pharmaceutical innovation for human and veterinary medicines;

• Engaging with SMEs, partners and stakeholders.”

Under each theme, the objectives, the related actions, that should be taken, and the stakeholders, that should be involved, are identified. For each objective there is a timeline before which the objective should be met.

The first objective of the Action Plan is to “expand outreach to newly created innovative pharmaceutical companies by collaborating with public and private organisations and networks”. Accordingly, the EMA should focus on engaging with industry, academia, International and European (“EU”) partners, including EU Institutions and Agencies. One action that could lead to the fulfilment of the first objective is to provide conferences concerning EMA’s support services.

EMA also provides regulatory and development support tools. As a result, organising e-learning modules, webinars on matters interesting for SMEs could increase the regulatory knowledge of such enterprises.

The Action Plan also addresses certain objectives around the theme of the development of pharmaceutical innovation. Enhancing coordination between DG Research and Innovative Medicines Initiative (“IMI”) constitutes one of these objectives. The promotion of research in line with the Horizon 2020 and IMI is one of the actions intended to meet this objective. 

In light of the current developments in the healthcare sector, the Action Plan focuses on engagement with SMEs and industry stakeholders. The suggested action to meet this objective is to encourage medical technology and digital health industry stakeholders to be registered with the EMA. That could be achieved through targeted communications between EMA and concerned stakeholders.