Shirley Meschke: “We are committed to making our Covid-19 vaccine meet the needs of world public health”
Shirley Meschke is Director of Legal Affairs for Brazil at Pfizer, one of the world's premier biopharmaceutical companies which notably developed the Pfizer/BioNTech vaccine, the global Covid-19 vaccine of choice, with over 3.5 billion doses purchased so far. In this interview, Ms. Meschke discusses how the pharmaceutical industry has evolved over the last 15 years, the legal and regulatory challenges of bringing the Pfizer/BioNTech vaccine to Brazil and the main impacts of the pandemic on the pharmaceutical sector, amongst other issues.
Leaders League: You’ve been working at Pfizer since 2006 and have led its Brazil and SoLA cluster legal department since 2013. Which major transformations have taken place in the Brazilian pharmaceutical sector over the last 15 years?
Shirley Meschke: Within the context of digital transformation, the health sector is constantly developing and, consequently, the strategies of pharmaceutical industries are following suit, with an enhanced focus on patients, increased access to innovative therapies, and greater awareness of disease prevention.
Digital transformation has brought about new platforms which allow us to study high volumes of data and analyze it (Big Data & Data Analytics), commercial partnerships based on performance, patient support programs and new alternatives for appointments between doctors and patients (telemedicine), a better integration of tests and diagnosis, the delivery of medicines via drones, and a range of communication channels.
The industry, as part of the sector's productive chain, has the objective of contributing to this debate and towards the search for new advances in health as well as to propose solutions which contribute to the quality, equity, and sustainability of the Brazilian pharmaceutical system.
It is also essential for legislation to accompany such changes and regulate 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 commercialization of pharmaceutical products, clinical research, medical applications, telemedicine, online prescriptions, medical marketing, and advertising, besides 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 division have been adapted to these constant changes, which require an increasingly efficient use of resources, a deep knowledge of the business units, and empowering internal clients towards relevant preliminary assessments by defining basic principles which guide legal analyses.
What are the main challenges of leading the Brazilian legal department of one of the largest pharmaceutical companies in the world?
The real challenge is to prepare the whole team for the critical role they will play in the future, to continue providing effective and efficient support in a scenario of new demands and different needs. The early identification of the need for change in lawyers' roles, competencies, vision, and approaches is challenging. Therefore, our strategic plan includes an annual review of future trends in our business environment, a review of the staff's development plan, which encompasses continued education, leadership in international projects, and high degrees of interaction with colleagues in external markets. It allows for the sharing of experiences, best practices and the optimization of resources.
Over 15 years, I had the opportunity to take on different roles in Brazil, Latin America, and international markets, besides participating and leading several working groups outside the country in the legal department and other areas of the company. It is essential to be exposed to new activities, leaders and colleagues both for professional growth and to build solid relationships.
Furthermore, I consider it essential to regularly review the structure of the department, rethink roles and responsibilities, review priorities with clients and managers, invest in technology, and define the basic principles that guide legal analysis. We must inform internal clients that legal involvement should target topics that require more in-depth 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 pandemic’s main impacts 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. Hence, in March 2020, early in the pandemic, Pfizer presented a plan with five measures calling for the collaboration of the biopharmaceutical industry in fighting the new coronavirus:
1. Sharing tools and ideas: Pfizer pledges to make the vital tools it develops available on an open-access platform to the scientific community. And to share the information and learning gained with other enterprises in real-time for the swifter development of therapies and vaccines.
2. Convening the staff: Pfizer has created a special tactical team comprised of our leading virologists, biologists, chemists, clinicians, epidemiologists, vaccine experts, pharmaceutical scientists, and other distinguished experts to focus exclusively on a solution to this pandemic.
3. Using our expertise in drug development: Several smaller biotech companies are investigating the activity of existing compounds or therapies against the virus causing Covid-19, but some lack expertise in late-stage development and the procedures of the complex regulatory systems. Pfizer is committed to sharing its expertise in clinical development and regulatory affairs to assist with the most promising discoveries created by these companies.
4.Making our production capacity available: As one of the leading manufacturers of vaccine and therapeutic products, Pfizer is committed to leveraging any additional production capacities and potentially shifting production to help others get these major life-saving breakthroughs into the hands of patients as quickly as possible.
5. Improving the speed of future responses: Pfizer is liaising with agencies to create an intersectoral rapid response team of scientists, physicians, and technicians who can swiftly mobilize in the event of future outbreaks.
The pharmaceutical sector was heavily impacted given its essential nature, relevance and efforts in fighting the pandemic.
New regulations 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 timeframe.
I believe that post-pandemic telemedicine should be regulated, together with other related aspects, like digital diagnosis, e-prescriptions, integrated solutions for patient follow-up, telemedicine, and more.
It must be said that the speed of technological advances is surprising, and therefore, companies must have appropriate strategies for the medium and long term. The whole sector must work together to regulate this issue to ensure its full and safe implementation.
Our company is known for vaccine research and development and in the business for more than 130 years. Along with other biopharmaceutical companies, we are making 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
When implementing 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 making our Covid-19 vaccine help meet the needs of world public health. The legal department played a critical role right from the beginning in supporting the clinical research topic in Brazil, supporting regulatory issues regarding the submission of the product application, and in the negotiations for the production and delivery of the Covid-19 vaccine. We are proud of this, especially in an unprecedented pandemic situation that required quick 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 roles and responsibilities of colleagues in the area.
Such adaptations demand high flexibility from staff, focus on the development of new knowledge and competencies. We have invested in technological tools that allow analytical evaluations of processes, performance monitoring, and metrics.
The sharing of best practices and experiences among colleagues in international markets and process simplification is also a strategic priority for the department.
Our diversity, inclusion, and pro bono programs are under revision for increased internal and external impact. The procurement process for services from partner law firms was reviewed and is more sophisticated. It now includes relevant elements going beyond quality, cost, and benefits analysis for potential social impact.
We are focusing on building a productive and cheerful work environment, where everyone feels motivated and acknowledged for their performance and work done, respecting, and prioritizing the balance between personal and professional life. Collaborative work has proved fundamental to achieve this goal.
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