Expert
Risto Salmi is the founder and expert of European
Pharmalaw Ltd.
By education, he is:
Master of Laws, Deputy Judge, Licenciate of Laws (European Union´s pharmaceutical law) and Master of European Union law and Comparative Contract Law. All academic degrees are from the University of Helsinki.
Risto Salmi has an extensive work experience in the
regulation / development of Finnish national and European Union pharmaceutical
legislation and its application in practice. He also has a lot of experience in
tasks related to company and contract legislation.
Salmi worked at the Finnish Medicines Agency (Fimea)
as a Negotiating Lawyer between 1997 and 2022 (25 years). During that
time, he was the representative of the Finnish state in the decision-making
bodies of the European Union Commission in decision-making related to medicines
(Finnish representative of the Commission's Standing Committees in Brussels
for 25 years and for Pharmaceutical Committee for 19 years).
Tasks included e.g. participation as Finland's
representative in the regulation and development of pharmaceutical legislation
in the European Union, as well as participation in decision-making related to
marketing authorizations for medicinal products and pharmacovigilance (centralised,
recognition and decentralized marketing authorisations).
In addition, during the aforementioned period, he
worked as "in house counsel" at the Finnish Medicines Agency.
Tasks included e.g. legal advice to companies related to clinical drug trials,
drug factories, drug wholesalers, sales licenses, retail distribution and drug
safety operations. He handled approximately 200 litigations as Fimea's lawyer
in the Finnish administrative courts and the European Union Court of Justice.
He was also a legal member of the Supervisory Board
of Fimea's internal decision-making body from 1999 to 2023 (the supervisory
board grants permits to pharmaceutical factories, drug stores and pharmacies in
Finland and supervises compliance with the permits).
He also has a significant work experience in
contract law and other business-related law from several years of working as a
partner in a law firm specializing in business law in Helsinki.
