The background

There’s growing concern that Europe does not currently have the right regulatory environment for innovative products and services in a range of industries, including the health sector. Carlos Moedas, EU Commissioner for Research, Science and Innovation, has said that more must be done to create a regulatory environment for innovation to flourish. He is committed to getting the conditions right for innovation in Europe, and making sure that regulation is based on an innovation principle as well as the precautionary principle.

So, the European Commission is looking to put in place a regulatory framework that can adapt to the pace of change of new technologies and innovation. Mr Moedas sees such a framework as essential for EU supplies of innovative products and services, to attract inward investment, and to maintain the benefits, (in terms of jobs, growth and environmental and social wellbeing), that come from those investments and the EU’s world leading position in research and development.

This is highly relevant to the health sector, due to complex and evolving regulation applicable to health care, and with increasing demand for health care services, and the pressure to reduce costs and demonstrate value driving the need to innovate.

The online survey

To progress this initiative, the Commission launched an online survey early in April. It gives industry and other stakeholders the opportunity to contribute their views on the Impact of Regulation on Innovation. The survey runs until 16 May 2016.

Much of the survey is tick box with the option to provide additional comments. It covers a range of issues and asks whether each issue is a driver, barrier, neutral or not applicable to innovation. The issues include the impact on innovation of environmental protection legislation, labelling and product safety legislation, as well as the conflicting requirements of different regulations and competition law.

One section of the survey is “only for respondents in the health sector”. This section focuses on the impact of EU health sector specific legislation, including patient safety, pharmaceuticals, medical devices/technologies and cross-border care. It also provides an option to give details regarding “other fields in which EU legislation is encouraging/discouraging innovation activities”.

There are also some open questions applicable to all sectors, such as whether a non-uniform implementation of EU regulations in Member States hinders innovation and whether any specific regulatory gaps exist.

It’s positive that the European Commission recognises the strong relationship between innovation and economic growth. It also acknowledges that the regulatory environment may be an enabling factor or a perceived or real barrier to innovation particularly to the health sector. This is your opportunity to “have your say”.

Link for the survey:

Link for the Directorate General for Research and Innovation webpage on Open Innovation: