External affairs
In their May 2014 meeting, the World Health Assembly (WHA), which is the supreme decision-making body for the World Health Organization (WHO), has approved a resolution on “Regulatory system strengthening for medical products”. In this resolution, medical products include medicines, vaccines, diagnostics and medical devices. It states the importance of the regulations of medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products; and acknowledges the need to support the area of medical devices.
The complete text of the Resolution can be found here:
On July 4, 2014, the General Secretariat of the Council of the European Union published a document in relation to the Council’s modifications to the Proposal for a Medical Devices Regulation. The most significant changes brought forward by the Council’s draft Proposal concern an extended focus on the “intended use” of medical devices during the evaluation process. The clinical evaluation of a new device must now contain “a comparison between the device and other treatments employed in the current clinical practice, if any”. The draft modifications also propose an extended deadline of 60 days (previously 35) for authorities to reply to applicants concerning the start of a clinical evaluation. Additionally, the Council’s draft reinforces the right of public access to the data generated during the clinical investigations.
The document published by the Council of the European Union can be found here:
On July 23, 2014, the European Research Council (ERC) Work Programme for 2015 has been published. The ERC, which is funded under Horizon 2020, has the unique idea of not having any particular topics as set criteria for funding and instead relies solely on the “excellence in science” principle to provide long-term funding for high-risk/ground breaking scientific pursuits.
The full 2015 Work Programme as well as timelines for submission etc can be found here:
On the July 24, 2014 the European Commission responded to criticism from over 700 scientists and students about the validity of the €1.2 billion Human Brain Project (HBP), one of the Horizon 2020 calls and one of the largest EU-funded initiatives. In its response, the European Commission remains steadfast in its support of HBP and is involved in an ongoing evaluation of the project so as to properly address their concerns. The initial article published in the Guardian newspaper on July 7, 2014 was potentially damaging as it questioned the value of simulation of the brain. Whilst this was by no means the main focus of the open letter by researchers that led to the article, the news item undoubtedly left the impression that computer models of the body are not worth pursuing.
On July 25, 2014, the Institution of Mechanical Engineers UK published a report stressing the urgent need for biomedical engineers in the UK National Health Executive (NHS). This report is of note given that it could lend itself to further convincing policy makers across Europe that funding for biomedical engineering is a policy option which must be prioritized. Additionally, the report further supports the findings of the World Health Organisation (WHO), who recently listed a shortage of biomedical engineers as one of the six key challenges for those countries suffering the most from chronic diseases. The report can be found here:
On September 9-10, 2014, the European Alliance for Personalized Medicine (EAPM) hosted its second annual conference in Brussels, Belgium. The ultimate goal of this conference was to raise awareness among policymakers about the intrinsic role of personalized medicine towards improving the lives of modern day patients. EAPM is a strong proponent for driving forward the concept of personalised medicine in Europe and beyond. With its broad base of stakeholders, drawn from industry, academia, science, research, the healthcare professions, patient groups, policymakers and more, the Alliance provides a platform for key motivated and expert personnel from a wide range of EU Member States.
The news items listed above present a summary of items taken from the European Alliance of Medical and Biological Engineering and Science (EAMBES) newsletter. You may be aware that the ESB, as a society, is a member of EAMBES. You, as a member of the ESB, are entitled to receive the benefits provided by EAMBES. This also includes the direct delivery of the EAMBES newsletter. When interested you can sign up to receive monthly updates, after filling in the EAMBES membership form at http://www.eambes.org/createMember
