Clear Guidance to Brave Regulatory ChangesBy Jan Hogewoning | Fri, 01/29/2021 - 15:18
Q: What services do you offer in the area of life sciences?
A: GC&A is a law firm with a cause. Our firm has a vertical for the life sciences and health sector. We provide a broad range of legal services to clients in areas such as contracts, intellectual property, regulatory and health obligations, import permissions, investment matters, contracting and more.
Another pillar is public policy. We find ways to collaborate with the government, with organizations, civil associations and the industry to advance the needs of the sector. It is important to have public policies that are firmly rooted in the law, ensuring that the Mexican state is obligated by constitutional right to provide adequate health services. Our team is multidisciplinary, including lawyers, political scientists, communication experts and regulatory framework experts. All our services are customized and based on one-on-one communication.
Q: What is an example of a public policy matter on which you have worked?
A: People who need fast treatment must have access to it. For example, those suffering a stroke require attention within a matter of hours. We are working on ensuring the legal provisions to homologate treatment criteria. Another topic is cannabis. Our firm is approaching the topic from a legal, social and political perspective. We have advised on certain modifications regarding legal opinions, which the government is discussing. Our focus is very much on medical cannabis and ensuring that there is clear regulation.
Q: Which companies can benefit from your services?
A: Some of our clients are multinational pharmaceutical companies. Others are 100 percent Mexican. We have also started to work with niche startups that are arriving in Mexico and bringing a great deal of added value to patients. We help constitute companies, developing their statutes and defining their social objective. We assist with sanitary and regulatory procedures, such as sanitary and import permits. We also help them find strategic allies in the country.
Q: How have these services been impacted by the new normality?
A: Frankly, there are many companies that think that with face masks, sprays, sanitation carpets and a rule to wash hands frequently, they are mitigating the spread of the virus and complying with the law. However, there are over 80 new federal provisions that regulate how we can return to the new normality under the Federal Labor Law, the Federal Health Law, not to mention the obligations stipulated by each state authority. While some companies have made successful transitions to home office, others always need to have part of their operation on-site. In these cases, all these provisions need to be met to make work permissible. For home office, there are other challenges. For example, clear rules should be established by a company to ensure people are not exceeding their work hours.
Q: What services do you provide regarding IP matters?
A: We work on defending brands and patents, and our firm has been recognized for its achievements in both IP and corporate law. Providing consistent service to clients is key to ensuring their property is protected. Many company lawyers come to us once they already have a problem. However, the most effective defense for IP comes from proactive and preventive actions.
Q: The government has opened tender processes to international companies. What are some of the concerns in this area?
A: There are several points to make here. First, the fact that there are multinational industries in Mexico does not necessarily mean they are foreign companies. They have a legal representation in Mexico. For this reason, they should be treated as part of the national industry. The reform to article 1 of the Acquisition Law increases pressure to acquire products from elsewhere. This is raising concerns regarding the quality, security and efficacy of new medications. The sanitary and regulatory standards of some countries are not homologated to those of Mexico. The potential consequence is a negative effect on the health of the Mexican population.
Second, the tender process as it is now is leaving the national market vulnerable. The national market should prevail. Yes, ad hoc negotiations should be able to take place to acquire medications under the best conditions. I believe everything is negotiable. The UNOPS scheme is interesting but in some countries, it has not provided the results that were expected. Health logistics in Mexico are complex. We know this government in particular intends to establish a public organization to take charge of this. However, this is not something that can be achieved in the short term. To buy abroad and have the government as sole distributor can generate shortages.
Q: What is the most effective tool for companies to challenge government decisions?
A: One objective of the amparo is to challenge an authority when it is believed to be violating a fundamental right. These fundamental rights are consecrated in the Constitution and are derived from universal human rights. If any of these are violated, you can file an amparo. We know there have been initiatives from the private sector, industry associations and even the Senate to contain the effects of the reform to the Acquisition Law. Amparos will always be an important shield.
Castillo, Government & Attorneys - CG&A, Legal y Asuntos Públicos was founded in 2015 to provide a comprehensive service in areas including public policy, anti-corruption, ethics, compliance, corporate law, intellectual property, fiduciary, labor law, foreign trade, sanitary regulation, public affairs and communications and administrative, civil and criminal litigation (amparos).