Nuevo escenario en el ámbito de los productossanitarios en la Unión Europea: Suiza y Reino Unido se convierten en terceros países / New scenario in the field of medical devices in the European Union: Switzerland and the United Kingdom become third countries

Objetivo: Comparar las medidas que se han tomado por parte dela Unión Europea, Suiza y Reino Unido para mantener la continuidadde mercado cumpliendo con los requisitos regulatorios del Reglamento 745/2017 de Productos Sanitarios.Método: Para realizar este trabajo se han revisado las webs oficialesde la Comisión Europea, la Agencia Española del Medicamento y Productos Sanitarios, la Swiss Agency for Therapeutic Products y la Medicines and Healthcare Products Regulatory Agency del Reino Unido y se hanrealizado búsquedas bibliográficas en PubMed y en internet (Google)con términos como “withdrawal Mutual Recognition Agreement of certificates of conformity European Union Switzerland medical devices, newregulation medical devices UK” y similares para un periodo comprendidoentre enero de 2020 y diciembre de 2021.Resultados: Como resultado del cese del marco legal que sosteníael libre comercio entre Suiza y Reino Unido de la Unión Europea, ladistribución de productos sanitarios se ha convertido en una importación,teniendo que cumplir con los requisitos legales pertinentes. Los distribuidores han pasado a ser importadores, y las declaraciones de conformidady certificados de Conformidad Europea han perdido su validez. Además,los Organismos Notificados ya no son reconocidos por la Comisión Europea. En consecuencia, Suiza, Reino Unido y la Unión Europea han tenidoque conceder periodos de gracia para permitir a las agencias reguladoras y operadores económicos adaptarse a las nuevas condiciones. (AU)

Objective: To compare the measures taken by the European Union, Switzerland and the United Kingdom to ensure the continuity of the medicaldevices market, complying with the requirements of Regulation 2017/745.Method: To carry out this work, a review was made of the official websites of the European Commission, the Spanish Agency for Medicines andHealth Products, the Swiss Agency for Therapeutic Products and the Medicines and Healthcare Products Regulatory Agency of the United Kingdom.Bibliographic searches were also conducted on Pubmed and the internet(Google), using terms such as “withdrawal of the Mutual Recognition Agreement of Swiss European Union medical device conformity certificates,new UK medical device regulation”, for a period extending from January2020 to December 2021.Results: As a result of the disappearance of the legal framework thatsupported free trade between Switzerland, the United Kingdom and theEuropean Union, products that used to be unrestrictedly distributed inEurope have become imports having to comply with the relevant legalrequirements. Distributors for their part have become importers, and declarations of conformity and CE certificates have lost their validity. Furthermore, notified bodies from Switzerland and the United Kingdom are nolonger recognized by the European Commission. Switzerland, the United Kingdom and the European Union have had to grant grace periods toallow regulatory agencies and economic operators to adapt to the newsituation. (AU)

Pharmaceutical Manufacturing in the EU and the EU-US Mutual Recognition Agreement.

The pharmaceutical industry is one of the most competitive sectors in Europe and has a strong presence in many European Union (EU) countries. The mutual recognition agreement (MRA) for inspections of medicines manufacturers between the United States (US) Food and Drug Administration (FDA) and the EU started by the end of 2017 and gradually extended to all EU member states (MSs) in July 2019. We quantified the number of FDA and EU good manufacturing practice (GMP) inspections carried out in each other's territory between 2009 and 2018. The five EU MSs with the largest number of FDA inspections were Germany, followed by Italy, France, the United Kingdom (UK), and Spain. All of them, with the exception of Germany, were included in the group of the first eight EU MSs recognized by the FDA in the context of the MRA. In 2018, these five EU MSs were within the top 10 EU exporters of pharmaceutical products to the US. Four of these five EU MSs (Italy, Germany, France, and the UK) accounted for 53.4% of the total pharmaceutical production in the EU in 2018. We also studied the type of manufacturing operations covered by the manufacturer's authorizations issued by each EU MS for the manufacturers within its territory. We verified a high prevalence of conventional technology versus complex technology manufacturing for many EU countries. Going forward, this unbalance should be addressed at a national and EU level. Supporting for instance (bio)pharmaceutical manufacturing through pharma policy initiatives, especially for EU countries with a lower level of innovation and technological development, would promote the pharmaceutical manufacturing sustainability and competitiveness of these countries. The full implementation of the MRA between the US FDA and the EU can make it faster and less costly for both sides to bring medicines to the market, improving future competitiveness of the EU and the US pharmaceutical industry.

Comparing the codes of ethics of the six signatory associations of the Mutual Recognition Agreement.

PURPOSE: The Agreement for the Mutual Recognition of Professional Association Credentials (MRA) between six national associations provides a mutually negotiated expedited process for applying for certification in speech-language pathology by any of the signatory associations. Although the MRA recognizes common standards in academic and clinical practice and eases the process to have credentials recognized, an interesting concept is that SLPs who have membership in more than one association must adhere to the code of ethics in each association. Thus, as SLPs will need to abide by them the question then becomes, are the codes of ethics in the six national associations comparable? METHOD: Using a content analysis procedure, the authors sought to identify similarities between the six codes of ethics. RESULT: The results revealed similarities between the six codes in areas such as responsibility to clients, professional conduct and practitioner competence. CONCLUSION: The findings should not to be interpreted to imply that one code of ethics was better or more comprehensive than another, as each code of ethics must be understood and interpreted in temporal, situational and local cultural contexts. Rather, the discussion includes a proposal to create a unified document.

Mutual recognition policy of medical license for medical professionals under Free Trade Agreement

Discussion on movement of medical personnel arises as a main issue when contracting free trade agreement between two countries. It is sensitive issue for both developed and developing country in terms of their own interest; developed country requires movement of medical personnel in order to solve aging population and manpower shortage problems in certain medical fields, whereas developing countries approache this issue with the purpose of exporting health professionals and improving the quality of medical care. We have not settled mutual recognition for medical professional's license, including that of medical doctors in Free Trade Agreement. However, as the opening of service sector expands is gradually, labor exchange of medical professionals at international level is expected to be more active in the future. Therefore, preparing quality of license at developed countries' standards and post management system is urgently required. Also, we have to strive for modification of law as well as global-level qualification to assist domestic professionals to enter overseas market.