The Lain American Lawyer: March 2018 Latam_March 2018

Report Pacific Alliance Regulatory conflicts stifling life sciences sector in Pacific Alliance Lack of regulatory harmonisation across Chile, Colombia, Mexico and Peru presents tough choices to life sciences companies With no common rules for patent protection or regulatory matters in the life sciences sector within the Pacific Alliance, mounting restrictions have a negative impact on companies expanding their business in the region, according to new research. However, this lack of uniformity is carving out a significant role for law firms. Ignacio Gillmore, partner at Chilean law firm Carey says that companies have to confront a diverse and fast-changing regulatory landscape, which varies from country to country. Harmonisation efforts to adequately adapt to local requirements – different local labelling, packaging, advertising, traceability – will surely prove key in helping companies expand through the region, he says. In addition, Gillmore sees that global pharmaceutical innovation is moving towards personalised medicine, niche pharmaceutical and bio-therapeutic products, orphan drugs and state-of-the-art medical devices. “For a region dominated by developing countries, the question is how to secure governmental expenditure and public and private reimbursement, to cover high cost pharmaceuticals and devices,” he adds. José Alberto Campos Vargas, partner at Sánchez DeVanny Eseverri in Mexico City, points out to the common disconnection between speed of new discoveries and the slow progress of legal provisions. Life sciences being viewed as an industry which should be subject to meticulous scrutiny by the regulatory authorities does not help with the current situation, he adds. “The authorities see a confrontation between health rights versus other rights such as freedom of choice, intellectual property, or free competition,” says Ariela Agosin, partner at Albagli Zaliasnik in Chile. “Regulations in the different areas of life sciences are creating an illusory conflict between those rights. Those issues complicate the progress of industries such as pharmaceutical, A company biotechnology, food and beverages.” Furthermore, arriving in the Pacific such arguments are Alliance must have a unnecessary, as these rights country-by-country are not just complementary approach. but need each other, says Agosin. “We see this Helena Camargo restrictive regulation Posse Herrera Ruiz regarding health as the bigger challenge.” “ www.thelatinamericanlawyer.com ” According to Juan Pablo Egaña, partner at Sargent & Krahn, also in Chile, the main common challenges from a legal perspective are those surrounding intellectual property and regulatory laws and regulations. “In the intellectual property field at least, Chile, Peru and Colombia have struggled with pharmaceutical patents and their impact in access to health,” he says. “This problem has led to ill-conceived attempts by NGOs to request compulsory licenses with the sole purpose of reducing prices of medicines, rather than using this legal tool to its intended purpose.” From a regulatory perspective, Egaña believes that the data exclusivity rules that are in place in each of these countries, still fail to appropriately shield biotechnological products with a more extended period of protection than those which are chemically synthesised. Striving for integration Andrea Pieschacon, associate at Gómez-Pinzón in Colombia, March 2018 • THE LATIN AMERICAN LAWYER • 13

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