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Moisés Ramírez: "The best in-house lawyers don't just avoid risks but identify opportunities to create value"
The legal director of GSK discusses how lawyers can influence regulations, the added value he seeks from external counsel and how GSK is addressing the effects of Covid-19.
Leaders League: You’ve acted in cases that have resulted in a number of significant changes to the law. Could you walk us through a couple of highlights?
Moisés Ramírez: I can speak about a couple of highlights from my time at Teva. Years ago, a new law was passed whereby discounts on drugs sold by pharmaceutical companies to pharmacies were limited to 10%. Discounts much higher than that being customary until then, this change became a big issue for generics companies because doctors prescribed active ingredients (as opposed to specific brands), and the ability to compete on price was materially reduced: generics had almost no capacity to differentiate their products between themselves, let alone versus the original brand.
After a long period of discussions with the authorities, we made them understand the benefits of restoring the previous level of competition in the market. They eventually agreed to amend the Spanish Medicines Act in 2015 to eliminate the discounts limitation and return to the previous situation. Another highlight came when I collaborated with the IP litigation team at Teva to introduce a new patent litigation practice in Spain: whenever we planned to launch a product “at risk” and suspected that an ex parte preliminary injunction would be sought by the innovator holding the patent to prevent such a launch, we would send the patent court a “preventive letter” to make the judge aware of the grounds on which such an ex parte preliminary injunction should be dismissed.
Thus, we were able to share our arguments with the court before they could make a decision having only heard the patent holder’s arguments and not ours. This practice was initially accepted by the courts, and shortly thereafter included in the Spanish Patents Act of 2015.
High quality and responsiveness are my top requirements when hiring external counsel
What key skills did you learn at Teva that have proved useful in your work at GSK in Spain?
I came to understand the strategy and business of generics, in terms of competition but also in terms of patent litigation. Their motivations and strategies are very different to those of innovators and I believe that this experience allows me to be a better adviser to GSK, especially in certain related areas. At Teva, even if we had a central patent team that worked with external law firms, the role of the local counsel was very important: we had the knowledge about the local market and business (pricing, regulatory, commercial particularities, etc.), and were probably the only ones who could cover those blind spots. This kind of bridging has served me well in my career.
You are currently on the executive board at GSK Spain. What role does Legal play in the company’s direction?
As part of the management team, I value most my ability to contribute to the company’s direction in Spain and the other countries that I oversee. An in-house lawyer in pharmaceuticals needs to know not just the regulations but also the industry and how the pharma business and his/her own company works.
You need to be a good gatekeeper and for that you have to know the business and its risks well. Everyone understands that; it has been the traditional role of the inhouse lawyer. Nowadays, in-house lawyers are bound to go beyond that. We need to be a real partner to the business, understanding its needs, being able to spot the less obvious routes to success, and providing advice accordingly. It is imperative for in-house lawyers to align with the business mindset.
Finally, an excellent in-house lawyer should also try to have an impact on the numbers of the company, not only by avoiding risks and potential fines, but also by identifying legal opportunities to create value. For example, if the opportunities arise, lawyers can challenge certain unfair practices by competitors, or authorities’ decisions, or can take advantage of some regulatory changes. Other areas where a legal department can add value are public tenders or material contracts for the company where the way in which you draft, interpret or enforce a critical clause can result in material contributions to the business.
When you hire external advisors, what do you look for?
It’s important for them to have extensive technical knowledge, but it is also critical to know about my company and the business in which it operates. That’s why it is not always easy to hire or find new external counsel. In fact, in Spain we have great external lawyers in life sciences but not as many alternatives as in other countries like the UK. I also demand something which may seem obvious: their interest. Interest in providing advice to me, to my company and on my issue. The tangible outcome of this is that they show availability and react fast. This is something that is taken for granted by many people but does not always occur. It is known that external lawyers handle a very large workload. There are some lawyers that tend to give the impression of being overworked and others who show their ability to handle things. That ability generates the trust and comfort that is critical for a client to entrust them with a matter. Therefore, high quality and responsiveness are my top requirements when hiring external counsel. Other factors like price do have their importance. In case of budget constraints I prefer to outsource fewer matters but only to the best professionals.
In studies, one of our Covid-19 products showed reduction of hospitalisations and deaths by 85%
What are the most exciting things GSK is currently working on in connection with Covid-19?
Our foremost contribution in the fight against Covid-19 is using our science to develop solutions. We are also doing everything we can to ensure the health and wellbeing of our patients, customers, employees and communities.
Since the pandemic began, we have been seeking ways to harness our scientific expertise and technology to make a difference. As a result, we are working with several partners to develop potential Covid- 19 vaccines and treatments as quickly and safely as possible.
In the vaccine field, we have some interesting research projects, such as our alliance with Sanofi, an unprecedented vaccine collaboration between two worldwide leaders in vaccines to fight Covid-19. We are also working on projects to develop new vaccines with other companies, including Canadian company Medicago, and German company CureVac with which we are working to develop a next-generation vaccine with the potential to address multiple emerging variants of Covid-19 at once. We expect more vaccine- related products to be available later this year, with the objective to get as many people as possible vaccinated. With this goal in mind, we have also agreements in place with CureVac to support the manufacturing of 100 million doses of its first-generation Covid-19 vaccine candidate in 2021. In March, we announced our agreement to support the manufacturing of up to 60 million doses of Novavax’s Covid-19 vaccine candidate for use in the UK; doses will be produced as early as May 2021.
In parallel, GSK is researching the development of potential treatment options for Covid-19 patients. It is critical that those who are infected can be adequately treated. Therefore, we are collaborating with Vir Biotechnology to develop new dual action monoclonal antibodies, which could be used as therapeutic or preventive options for Covid-19. It was recently announced that studies in relation to one of our Vir/GSK products showed reduction of hospitalisations and deaths by 85%. GSK is now seeking an Emergency Use Authorization for this potential treatment with the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has also started review of this product. We also intend to seek authorisation in other countries.
We have also reviewed the portfolio of our medicines that were already under development when the pandemic broke out and found that one of our potential new medicines, also a monoclonal antibody, can help treating adult patients who are hospitalised with Covid-19-related pulmonary disease.
It is unclear at this point whether we will eradicate Covid-19 or whether we will need to live with it. That’s why pharmaceutical companies in general, and GSK in particular, need to keep making outstanding efforts to play their critical role against this pandemic.
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