Innovation in the product sector – Council conclusions

The importance of innovative solutions in the pharmaceutical industry is needed and desirable as in any other sector, as they can translate directly into improving the health and life of many people. Innovation in the context of medical devices was highlighted by the Council in its conclusions on innovation in the medical device sector published on 8 July 2011.

The Council identifies as beneficiaries of such innovations not only patients, but also health professionals and industry and society in general, while stressing that, in order to be able to bring the right benefits, they should be increasingly patient and user-oriented and should be based on demand, which can be achieved, for example, through the increasing participation of patients, their families and users in the research process. , innovation and development to improve individual health and quality of life. In turn, the innovation process itself should be better integrated and draw on the experience and knowledge acquired in other sectors, such as IT and the development of new materials. The Council points to the need for a broad understanding and understanding of the essence of innovation in this sector, which should be based on a holistic approach (i.e. it should take into account the whole health care process and all patient needs – physical, social, psychological, etc.) while focusing on public health priorities and healthcare needs, in order to improve the cost-benefit ratio.

In view of the above, the Council adopted the need to establish a precise objective for future legislative action in this area, which is primarily to increase patient safety, while creating a stable legal framework conducive to innovation in the field of medical devices, which can contribute to ensuring a healthy, active and independent life.

The conclusions also provide specific incentives for both EU Member States and the Commission and the Commission itself to take appropriate action to achieve the previously stated objective. The first group of incentives included, inter alia, the promotion of measures using valuable innovative solutions with proven benefits and the improvement of information and training on their use for healthcare professionals and patients and their families; taking into account existing measures and, if necessary, considering the adoption of further measures that will strengthen innovation capacities, such as the use of innovative funding schemes specifically targeted at small and medium-sized enterprises and designed to make optimal use of private and public sector resources, or an analysis of how and at what level the promotion of medical devices could be regulated in the most efficient and effective way. The Council also attached great importance to improving cooperation and dialogue between the various participants in the whole innovation process and the relevant responsible bodies.

On the other hand, the section on issues to be taken into account by the Commission in future legislative work mentions, in particular, the need to strengthen the reliability, predictability, pace and transparency of the decision-making process and to ensure that it is based on scientifically validated data; improving the risk-based classification system (in particular in vitro diagnostic medical devices and, where appropriate, 'new devices'); ensuring clearer and simpler rules for determining the obligations and responsibilities of all economic operators and the role of other stakeholders (in particular competent national authorities and notified bodies). The response to the numerous practical problems of interpretation was also an indication of the need to establish a simple and rapid mechanism for the accelerated adoption of binding and consistent decisions and their implementation with regard to the designation of products as medical devices and the classification of medical devices in order to address the increasing number of borderline cases between medical devices and other products subject to different regulatory frameworks (framework for pharmaceutical products in particular) , but also a framework for cosmetics, care products, food and biocides).

KONDRAT Law Firm and Partners

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