Christian López
PhD, Partner and Head of Pharmaceutical & Life Sciences
Baker & McKenzie
View from the Top

Integral Legal Solutions for Healthcare Innovation

Wed, 09/07/2016 - 14:43

Q: You have mentioned that Baker & McKenzie is Mexico's largest and most advanced regulatory practice. How have you retained that position in an extremely competitive field?

B&M keeps generating synergies between our different groups of practice, finding new opportunities to integrate health regulation to previously unconnected areas, which has resulted in value-added services for the life sciences industry. For instance, we integrated regulatory work with privacy law and information technologies, resulting in our Digital Healthcare Initiative, which places us well ahead in the market of legal services, particularly for our clients in the medical devices sector. Likewise, we have increased the integration of our regulatory and litigation capabilities, winning several cases against regulatory decisions for our clients in the pharmaceutical sector.

Q: How is the firm’s internationalization and understanding of global markets reflected in its client’s operations?

Our global view and regional experience has been appreciated by our clients. One visible indicator is that we have increased the number of Latam-wide projects. For instance, we are implementing a regional project to develop compliance policies for every country in Latam where a pharmaceutical client has a presence. We are also executing, for a global cosmetics company, a regional mapping exercise of individual countries, aimed at identifying available mechanisms to accelerate access to the whole regional market. We are also helping a pharma client create a mobile app to generate information about regulatory developments in Latam in the area of biosimilars.

Q: How does Baker & McKenzie ensure its involvement through the whole life cycle of a drug or medical device? What does this mean to the company and its clients?

Being a full-services law firm gives B&M a privileged position to assist during the whole life cycle of regulated products. For example, we are currently developing a Licensing & Regulatory Initiative for Drugs in Latam, which integrates the different regulatory, intellectual property and corporate law aspects that derive from technology transfer projects and M&A transactions. 

Q: In which way do evolving regulations impact your client’s operations?

Let us take a look at medical products. By official accounts, the area that has gone through more profound regulatory changes in recent years has been the sector of medical devices. Not only were new provisions developed (e.g. techno-vigilance rules), but also old provisions were completely revised and resulted in a deregulation and simplification of the approval process of these products. Moreover, international recognition plans were agreed with other countries, which has not only expedited the approval in Mexico of products already authorized by other foreign regulators, but has also made it possible for approvals obtained in Mexico to be recognized in other countries.

Q: How does Baker & McKenzie help its clients stay ahead of the herd in a growingly competitive environment?

We have designed legal strategies to manage the regulatory, antitrust and compliance implications of Patient Support Programs. Companies in the life sciences industries are moving away from a product-only business model and moving into a more product-plus-service model, which is making a reality today what others expected to take place in the future. Also, we are constantly preparing specialized content and reports in the Life Sciences sector, which is made available to our clients in new ways. The best example of this is our recently launched mobile app, called MapApp, which puts key legal content literally at the fingertips of our clients. This covers every country where we operate and more.

Q: How can we improve the legal environment of Mexico, making it more attractive and desirable for foreign enterprises to set-up-shop in the country?

For many years several regulators in Mexico were accustomed to the fact that their main decisions were not regularly challenged in courts. This has slowed down the emergence of legal precedents that are much needed in several aspects. This is unfortunate since being able to challenge decisions is a crucial component towards achieving a true and effective rule of law.