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The Medical Affairs department within pharmaceutical companies is a critical component responsible for bridging the gap between the scientific aspects of the company’s products and the practical application of these products in healthcare settings. Their primary focus revolves around supporting and communicating the medical and scientific value of the company’s products to various stakeholders, including healthcare professionals, regulatory bodies, and internal teams. In some multinational pharmaceutical companies, even the marketing used to be under a medical director and was called medical marketing. Things have changed over time, and we shall discuss that also.
The rise of local pharma which is entirely based on generic medicines has changed the scenario in Pakistan significantly. Medical Affairs departments lost much of their value and visibility, or they were restricted to doing training of sales teams. It happened as the marketing became more and more commercial and selling focused on material benefits rather than clinical outcomes.
Here are some functions that medical affairs department should be assigned to handle.
Functions of Medical Affairs
- Medical Information and Communication: Providing accurate, evidence-based information on products to healthcare professionals, answering inquiries, and ensuring compliance with regulations and guidelines.
- Clinical Research and Development: Overseeing the design, implementation, and analysis of clinical trials to ensure scientific rigor and ethical standards. This includes post-market research and real-world evidence studies.
- Key Opinion Leader (KOL) Engagement: Building relationships with leading experts in the field to gather insights, seek advice, and collaborate on research and educational initiatives.
- Regulatory Compliance and Pharmacovigilance: Ensuring compliance with regulatory standards and monitoring product safety and adverse events.
- Medical Education and Training: Providing training and educational materials for internal teams, healthcare providers, and patients.
- Health Economics and Outcomes Research (HEOR): Assessing the economic and clinical value of products, including cost-effectiveness analyses and real-world data assessments.
Evolution of Medical Affairs
Internationally, the role of Medical Affairs has evolved significantly in recent years due to various factors.
- Shift towards Evidence-based Medicine: With an increasing emphasis on evidence-based medicine, Medical Affairs has become central in generating and disseminating scientific evidence supporting product efficacy and safety.
- Growing Regulatory Scrutiny: Increasing regulatory scrutiny demands greater transparency and adherence to compliance standards, making the role of Medical Affairs pivotal in ensuring adherence to regulations and ethical standards.
- Digital Transformation: The digital era has opened new avenues for communication, education, and research. Medical Affairs departments are utilizing digital tools for information dissemination, physician education, and even patient engagement.
- Patient-Centric Approach: There is a shift towards a more patient-centric approach, and Medical Affairs departments are focusing on providing information not just to healthcare professionals but also to patients to ensure informed decision-making.
Future of Medical Affairs
McKinsey has published an article in October 2023 titled ‘A vision for medical affairs 2030: Five priorities for patient impact’. It is a very significant article with very good information which I would like to discuss separately. Much of it may not be applicable to Pakistan Pharma Industry, but we shall see what is being considered in the pharma landscape internationally. The future trajectory of Medical Affairs in generic pharmaceutical companies should involve following key changes.
- Enhanced Digital Integration: Advanced digital technologies should be integrated to disseminate information, conduct virtual medical education, and engage with healthcare professionals and patients. Barring a handful top-tier companies, majority is not focusing on disseminating medical information. I believe that the commercialism should now be put at the second step. The job of pharma companies is not just to sell drugs by whichever way, it is also to provide relevant information to doctors and patients.
- Real-World Evidence and Data Analytics: Increased reliance on real-world evidence and data analytics should be considered to assess product value, safety, and efficacy in real-life scenarios. Generic companies must generate clinical data based on their own brands. This would also mean that the formulations must be fixed and validated and the practice of changing sources for saving a few dollars must be seriously discouraged.
- Personalized Medicine and Precision Health: Medical Affairs will play a crucial role in educating and collaborating on personalized medicine approaches and therapies tailored to individuals. Precision medicine has already made an important place in healthcare. Pharmacists should work along with doctor to bring the benefits of personalized medicine to patients.
- Expanded Patient Involvement: Increasing focus on directly engaging and educating patients to empower them in decision-making about their healthcare. Direct to Consumers – DTC is now allowed in selected cases by regulatory authorities. Medical Affairs department of Pharma company shall not prescribe medicine to patients but will educate the patients about the use of prescribed drug(s).
- Adapting to Global Health Challenges and Opportunities: Medical Affairs department should constantly scour the global health landscape and pick up challenges and opportunities early. It is not the job of business development; it is for Medical Affairs to handle it.
- Greater Collaboration and Interdisciplinary Approach: Medical Affairs department should Collaborate with other departments within pharmaceutical companies and external partners, like healthcare institutions and technology firms, to create a comprehensive, holistic approach to healthcare solutions. They should help Marketing department find points to develop marketing pitch, they should validate the authenticity of medical information in marketing campaigns, and they should train the sales teams in collaboration with others.
Overall, the future of Medical Affairs continues to evolve in response to advancements in technology, changing healthcare needs, and the demand for transparent, evidence-based medicine. Adaptability, innovation, and a patient-centric approach will be pivotal in shaping the future course of Medical Affairs in pharmaceutical companies.