Report Pacific Alliance

believes fulfilling common technical and legal requirements from the health authorities requires dynamism . “ This involves designing regional investment strategies in the research and development of competitive and novel products , in order to meet the highest standards ,” she says . Meanwhile , Helena Camargo , partner at Posse Herrera Ruiz in Bogota , notes there are no common rules for patent protection or regulatory matters through the trading bloc . “ Therefore , the big challenge these companies face is the multiplicity of different rules , requisites and practices across the region .” She adds that the necessary technical information has to be planned for each country , as there is not uniformity in what each of the relevant authorities will request . “ A company that arrives in the Pacific Alliance needs to have a country-by-country

approach ,” Camargo says . Restrictive

Ricardo De Vettor , senior associate at Rodrigo , Elías & Medrano in Lima , Peru , also argues that there are no regional trends or strategies regarding these products [ with the exception of cosmetic products ]. “ The permits required to import , distribute and commercialise the rest of the mentioned products vary , depending on the local legislation of each country ,”

Merieux NutriSciences Corporation

United States

Tecnimicro Laboratorio de Analisis

Colombia Not disclosed

Supplied by TTR - Transactional Track Recor he says , before highlighting another issue in Peru . “ Our local laws prohibit foreign companies from owning sanitary authorisations ,”

health regulation is a big challenge for life sciences companies .

he says . “ The problem with this situation is that overseas companies must enter into business alliances with local players and be subject to their goodwill .”

Elsewhere , Maritza Reátegui , partner at Peruvian law firm Muñiz , Olaya , Meléndez , Castro , Ono & Herrera Abogados , highlights that the biggest challenge for life science companies is the integration of the regulations in the individual countries of the Pacific Alliance , which requires that all stakeholders are convinced of their viability and implementation . “ A change of culture is required to take advantage of the opportunities for the exchange of products and services ,” she adds .

However , such is the need for life science companies to have the best possible legal certainty and safety , that lawyers in the Pacific Alliance countries find growing opportunities advising clients in the sector . “ Lawyers must be the strategic advisor of the company ,” says Pieschacon . Campos Vargas agrees . “ The greatest opportunity is to provide clients and players in these industries with a comprehensive analysis of the local market and the related legal system ,” he explains . “ Lawyers must be knowledgeable not only in their specific field of expertise or practice , but must also understand the industry as a whole , as well as able to provide a comprehensive view of the challenges .”

Lawyers must have a clear , complete and extensive experience in the technical side in addition

14 • THE LATIN AMERICAN LAWYER • March 2018 www . thelatinamericanlawyer . com