Leaders League: You have been working at Pfizer since 2006 and leading the legal department of the Brazil cluster and SoLA since 2013. What major transformations have taken place in the Brazilian pharmaceutical sector over the past 15 years?
Shirley Meschke: In the context of digital transformation, the healthcare sector is constantly evolving and as a result, the strategies of the pharmaceutical industries are following suit with increased focus on patients, increased access to innovative therapies and increased awareness of disease prevention.
The digital transformation has given rise to new platforms that allow the study and analysis of large volumes of data (Big Data & Data Analytics), performance-based business partnerships, patient support programs and new alternatives. appointments between doctors and patients (telemedicine), better integration of tests and diagnostics, drug delivery via drones and a range of communication channels.
The industry, as part of the productive chain of the sector, aims to contribute to this debate and to the search for new advances in health as well as to propose solutions that contribute to quality, equity and the sustainability of the Brazilian pharmaceutical system.
It is also essential that the legislation accompanies these changes and regulates the new possibilities of transactions and partnerships. In this sense, we have seen decisive advances in Brazil in recent years in the regulation of authorizations for the marketing of pharmaceuticals, clinical research, medical applications, telemedicine, online prescriptions, medical marketing and the publicity, in addition to the edition of a new law on privacy and data protection and other changes in legislation regulating the sector.
In terms of legal support, the structure and approach of the legal department have been adapted to these constant changes, which require an ever more efficient use of resources, in-depth knowledge of the businesses, and the empowerment of internal clients towards prior assessments. relevant by defining the basic principles that guide legal analyzes.
What are the main challenges of leading the Brazilian legal department of one of the world’s largest pharmaceutical companies?
The real challenge is to prepare the whole team for the essential role it will play in the future, to continue to provide effective and efficient support in a scenario of new demands and different needs. Early identification of the need for change in the roles, skills, vision and approaches of lawyers is difficult. Therefore, our strategic plan includes an annual review of future trends in our business environment, a review of the staff development plan, which encompasses continuing education, leadership in international projects and a high degree of interaction with colleagues on external markets. It allows the sharing of experiences, good practices and optimization of resources.
During 15 years, I had the opportunity to assume different roles in Brazil, Latin America and international markets, in addition to participating and leading several working groups abroad within the legal department and ‘other areas of the business. Being exposed to new activities, leaders and colleagues is essential both for professional growth and for building strong relationships.
In addition, I consider it essential to regularly review the structure of the department, to rethink roles and responsibilities, to review priorities with clients and managers, to invest in technology and to define the basic principles. that guide the legal analysis. We need to educate internal clients that legal intervention should target topics that require further study and risk analysis.
The best way to deal with the Covid-19 scenario is to unite the resources and expertise of the entire pharmaceutical industry
What were the main impacts of the pandemic on the Brazilian pharmaceutical sector in legal and regulatory terms? What industry trends are likely to materialize over the next 12 months and beyond?
We believe that the best way to deal with the Covid-19 scenario is to unite the resources and expertise of the entire pharmaceutical industry. Thus, in March 2020, at the start of the pandemic, Pfizer presented a plan comprising five measures calling for the collaboration of the biopharmaceutical industry in the fight against the new coronavirus:
1. Sharing tools and ideas: Pfizer is committed to making the vital tools it develops available to the scientific community on an open access platform. And share the information and knowledge acquired with other companies in real time to accelerate the development of therapies and vaccines.
2. Summons of staff: Pfizer has created a special tactical team made up of our leading virologists, biologists, chemists, clinicians, epidemiologists, vaccine experts, pharmaceutical scientists and other eminent experts to focus exclusively on a solution to this pandemic.
3. Use our expertise in drug development: Several small biotech companies are studying the activity of existing compounds or therapies against the virus that causes Covid-19, but some lack expertise in late-stage development and procedures for complex regulatory systems. Pfizer is committed to sharing its expertise in clinical development and regulatory affairs to support the most promising discoveries created by these companies.
4.Provide our production capacity: As a leading manufacturer of vaccines and therapeutics, Pfizer is committed to leveraging any additional production capacity and potentially shifting production to help others put these major advancements in the hands of people. patients as quickly as possible.
5. Improve the speed of future responses: Pfizer is liaising with agencies to create an intersectoral rapid response team of scientists, doctors and technicians who can mobilize quickly in the event of future epidemics.
The pharmaceutical sector has been strongly impacted given its essential character, its relevance and its efforts in the fight against the pandemic.
New regulations have emerged seeking to authorize and guide the health sector on the possibility of using, for example, telemedicine and electronic prescriptions in Brazil, but within a defined time frame.
I think post-pandemic telemedicine should be regulated, along with other related aspects like digital diagnostics, electronic prescriptions, integrated solutions for patient tracking, telemedicine, etc.
It must be said that the speed of technological advances is surprising, and therefore, companies must have adapted strategies in the medium and long term. The whole sector must work together to regulate this issue to ensure its full and safe implementation.
Our company has been known for vaccine research and development and in the industry for over 130 years. Together with other biopharmaceutical companies, we are writing history again with the successful development of a safe and effective vaccine against Covid-19.
New regulations have emerged on the possibility of using telemedicine and electronic prescriptions
During the implementation of Pfizer’s Covid-19 vaccine in Brazil, what main legal and regulatory challenges did you face? What was the role of the legal department during this process?
Pfizer prioritizes its patients around the world. We are committed to ensuring that our Covid-19 vaccine helps meet the needs of global public health. The Legal Department has played a vital role from the start in supporting the subject of clinical research in Brazil, supporting regulatory issues regarding the submission of the product request and in negotiations for the production and delivery of the Covid-19 vaccine. . We are proud of this, especially in an unprecedented pandemic situation that has required swift responses, commitment and hard work.
What new developments can we expect from Pfizer and its legal department in the next 12 months?
Pfizer’s Legal Department is constantly adapting to meet the challenges and dynamism of the industry and internal reorganizations that often require changes in the roles and responsibilities of colleagues in the field.
Such adaptations require a great deal of flexibility on the part of the staff, with an emphasis on the development of new knowledge and skills. We have invested in technology tools that enable analytical process evaluations, performance monitoring and metrics.
Sharing best practices and experiences with colleagues in international markets and streamlining processes is also a strategic priority for the department.
Our diversity, inclusion and pro bono programs are under review for increased internal and external impact. The procurement process for the services of partner law firms has been revised and is more sophisticated. It now includes relevant elements going beyond the analysis of quality, costs and benefits for potential social impact.
We focus on building a productive and joyful work environment, where everyone feels motivated and recognized for their performance and the work accomplished, respecting and favoring the balance between personal and professional life. Collaborative work has proven to be fundamental to achieving this goal.