Ernesto Algaba
Partner of the Life and Sciences Practice
Hogan Lovells BSTL
Cecilia Stanlhut
Cecilia Stanlhut
Senior Associate of the Life and Sciences Practice
Hogan Lovells BSTL
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Filling in the Regulatory Gaps

Wed, 09/05/2018 - 09:55

Q: In what regulatory areas are companies most interested in acquiring the services provided by Hogan Lovell?

EA: Clients request legal advice regarding the introduction of innovative products, new therapies and high-tech devices in the Mexican market. Access to medicine, promotional activities and patient programs are also among the important components of the advice we provide. In seeking our services, pharmaceutical companies assure that their practices comply with the applicable Mexican legal framework. Compliance not only impacts the country, it is also relevant under the American Foreign Corrupt Practices Act and UK Anti-Bribery Act.

Q: What opportunities result from rendering digital health services in Mexico?

CS: Even where there is a comprehensive regulation for the provision of traditional health services, there is no equivalent that exactly applies for digital or virtual health services. We need a specific regulatory framework as telemedicine evolves. We are facing a very fast development of service digitalization in areas such as prevention, health education and treatment follow-up. This is a challenge from a business and regulatory perspective.

EA: Several clients have been asking us about these topics. Given the lack of a particular legal framework, we need to continue working closely with the authorities to implement the appropriate regulation. This is the case in areas such as prescriptions, physician certifications, product procurement, medical records and follow-ups. Mexico’s framework is broad and strict in terms of data protection but the digital provision of medical services brings with it the need to address these issues comprehensively.

Q: What steps have been taken to develop this framework?

EA: Several years ago, the Ministry of Health developed some guidelines but they are too general. There is also a draft NOM. Although there are other priorities for issues such as access to treatments, inclusion of products and a complex political agenda, it is time to review the existing legal framework and adjust it to the needs of an evolving sector. Hogan Lovells has been finding ways to assist both

the authorities and the industry to implement measures that can be easily adopted. Our role is to help to adopt good practices and suggest some practical approaches that protect both our clients’ operations and the security of their patients.

Q: How have authorized third parties contributed to compliance in the Mexican health industry?

CS: The existence of authorized third parties has provided transparency and certainty when launching products and managing processes with COFEPRIS. Authorized third parties both speed up processes and take some of the administrative load off the authorities.

Q: In what health industry areas are Hogan Lovells’ clients participating?
EA: Eighty-five percent of our clients in the life and sciences division are transnationals. Hogan Lovells’ clients operate in areas such as pharmaceuticals, stem cells, biotechnology, medical devices, digital healthcare, cosmetics, alcohol, tobacco, food, supplements, genetically modified organisms, drug stores and distributors. Working with such a varied array of companies enables us to have a wider perspective regarding areas of opportunity and what will interest our clients.

Q: What are the priorities of Hogan Lovells’ life and sciences division?

CS: We strive to be one step ahead of our clients’ needs. Hogan Lovells is creative and provides added-value solutions. Clients usually have their own regulatory teams, so what we offer is both high specialization and integral solutions. If a client asks for advice on regulatory matters and we notice there is an issue with compliance, foreign trade, IP, or any other practice area, we can help them in those areas as well.