52
Edition nº
New Executive Board of the INFARMED
Is formally constituted
The new INFARMED Executive Board is now formally constituted. After the nomination of Professor Maria do Céu Machado as the President, Sofia Oliveira Martins was recently appointed member of the Board, replacing Professor Helder Mota Filipe.
Sofia Oliveira Martins is a Professor at Faculdade de Farmácia (Lisbon) and has a PhD in Pharmacy (Pharmacoepidemiology) at the same university, in which was also designated as a member of the Senate. Sofia Martins is also a member of the Board of Jurisdiction of the Pharmacists Association (Ordem dos Farmacêuticos) Southern Section.
Rui Santos Ivo remains as vice-president in this Board, which will last until January 2019.
Evaluation of medicinal products and devices
featured in the advisory council
The early identification of high potential medicines and other health technologies is one of the priorities set for the National System for the Assessment of Health Technologies (SiNATS). This will be one of the main goals established for the next semester by the INFARMED, which focused on the monitoring and re-evaluation of the contracts already signed, but also on the evaluation of innovative medicines.
The SiNATS was precisely one of the subjects covered in the scope of the Advisory Council of the Infarmed, which met on the 20th june. To accelerate the response on these matters, the Board intends to evaluate and to submit proposals for improving the Evaluation Committee of Health Technologies (CATS), which will be presented at the next meeting, on november 21st.
During this session, with 90% of the agencies represented, the new INFARMED Executive Board was introduced and the 2016 Activity Report discussed.
The new legislative framework of medical devices, which recently entered into force, was also presented in this session to the participants, such as the Portuguese Association of the Pharmaceutical Industry (APIFARMA), the Portuguese Association of Generic Medicines and Biossimilars (Apogen) and the Portuguese Association of Medical Devices (Apormed).
At the end of the session, APIFARMA proposed a vote of praise for INFARMED, which was unanimously approved. The motion was related to the portuguese bid to host EMA headquarters.
Experts call for more transparency
and better communication in the medicines area
The communication about science and the risks and benefits of the medicines need more transparency and information. This was one of the lessons brought within the “Conference on Science-based transparency: lessons for the health professionals and regulators", which took place on the 19th June in the INFARMED.
The Executive Board of the INFARMED hosted this event with two risk communication specialized speakers: Frederic Bouder, from the University of Maastricht (Netherlands) and Ragnar Löfstedt, director of the Center for Risk Management of King's College, in London.
Frederic Bouder revealed the results of studies conducted in this area, which envolved patients and physicians from several countries (UK, Sweden, Netherlands, Spain, Germany and France). The data showed wide variations and different results between countries, though it pointed that the citizens are willing to have more information about the safety of medicines, even at an earlier stage. On the other hand, the doctors tend to prefer the release of data only when they are more certain about the associated risks.
One of the concerns has been linked to the fact that some patients tend to reduce the dosage or even stop taking the medication when they fear its consequences. However, according to these experts, there are also advantages to consider, such as the increase in confidence when using medicines and also in the activity of the professionals and regulators.
European council discussed preventative health care
and increased access to medicines
The access to health technologies, transparency and the increase of the countries power of negotiation were under discussion at the last meeting of the Council of Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), attended by the Minister of Health, Adalberto Campos Fernandes, the president of INFARMED Executive Board, Maria do Céu Machado, as well as Eva Falcão, from the Directorate-General of Health.
The Council encouraged Member States to cooperate in order to improve the healthcare system and to ensure access to treatment, especially for the citizens with rare diseases. It was also recommended that the countries should implement measures to share information on national policies for fixing prices as well as an increase in the transparency of agreements concerning prices.
The childhood obesity was another topic of this meeting, held in Luxembourg on the 16th june. At the end of this council, the member states drew some recommendations such as the need for more resources in research projects and monitoring in this area. The European Ministers of Health, Employment, Social Affairs and Consumer Protection also concluded that the citizens need more access to health care, whether in the stages of treatment or prevention of the disease.
The Portuguese delegation met
The European Commissioner Vytenis Andriukaitis
The Portuguese delegation that travelled to Luxembourg had an opportunity to meet the European Commissioner for Health and Food Security in the margins of the EPSCO Council. At this meeting, the Commissioner addressed some of the main requirements that are relevant to ensure the business continuity of the European Agency for the Evaluation of Medicinal Products (EMEA).
These concerns were also discussed in bilateral meetings with several countries, such as Spain, Greece, the Netherlands and France.
The socialist ministers also met in the margins of the EPSCO Council in order to discuss other issues such as the access to innovation and other priorities for the European health sector, such as the sustainability of national systems.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Parque de Saúde de Lisboa - Avenida do Brasil, 53, 1749-004 Lisboa - Portugal
Telef: +351 217 987 100 | Fax: +351 217 987 316 | E-mail: Infarmed@Infarmed.pt