Tagged with P

France At the 13th annual meeting of French life sciences think tank, G5 Santé – which represents the leaders of eight major French health and life sciences companies, including bioMérieux, Sanofi, Ipsen, and Pierre Fabre – arguments were made for increasing efficiency in a healthcare system that is “on its last…

Switzerland Dr Frank Ruhli discusses the importance of attracting top talent and fostering academic freedom as key factors in achieving research excellence. Ruhli highlights his collaborative leadership style, significant achievements like establishing the One Health Institute, the value of international partnerships in advancing interdisciplinary medical research, and some of the key…

Switzerland Dr René Buholzer, CEO of Interpharma, covers Switzerland’s healthcare advancements, regulatory progress, and the challenges in drug access and digitalization over the past three years. Emphasising collaboration and innovation, Interpharma’s ‘Pharma Strategy 2030’ aims to solidify Switzerland’s leadership in R&D and healthcare sustainability.   Our vision is not just about…

Switzerland The Federal Office of Public Health (FOPH) is the body responsible for safeguarding public health in Switzerland, developing national health policies, and overseeing the Swiss healthcare system. In an exclusive conversation, FOPH Director Anne Lévy discusses the key challenges facing the Swiss healthcare system today and highlights potential solutions as…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), a decentralized Health Ministry (HM) agency, is responsible for applying and enforcing the regulatory framework regarding human medicines, biologicals, and medical devices.  …

Pharma Legal Handbook As a general introduction, clinical trials are regulated in Ecuador via the Ministerial Agreement (MA) 0075-2017 and reform 0006-2020, which relates to regulations for approving, developing, monitoring, and controlling clinical trials. This regulation was enacted on June 30th, 2017. Other rules and regulations make MA 0075-2017 enforceable. The Constitution of…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The General Health Law (HL) and its regulations govern traditional, complementary, and alternative medicines. These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof,…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from the Civil and Criminal Codes, and it is personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Any sign distinguishing goods and services on the market shall constitute a mark. Signs capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging, or wrapping may…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred.   2. When are they likely to come into force? Uncertain.

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…