We conclude our series of ECPA founders introductions by highlighting a prominent figure in the pharmaceutical industry: a seasoned attorney with over 12 years of legal experience - Rūta Karpičiūtė (Pumputienė)
What unique compliance challenges do pharmaceutical companies face compared to other industries?
"Pharmaceutical companies face several unique compliance challenges compared to other industries. First and foremost, the industry is one of a couple of industries that face extremely strict regulations. Starting from research and development, manufacture and distribution of pharmaceuticals, engagement of pharma industry with public officials, healthcare organisations and healthcare professionals, to protection of IP and quasi-IP rights such as patents and regulatory data protection.
Furthermore, the industry faces challenges regarding transparency, which means that anti-bribery and disclosure obligations also remain relevant for this industry. Therefore, before making any business decision, such decision must be evaluated not only from the regulatory but also from compliance perspectives, because in pharma industry there is not much freedom for interpretation.
Another issue for pharmaceutical companies is related with ethics. Sometimes certain activities are allowed by law, but they might not entirely be compliant with ethics requirements. Therefore, it is challenging to find a right balance between what is allowed, and what is ethical."
What are some of the most pressing compliance issues in the pharma industry today, and how can ECPA help address them?
"One of the biggest challenges in pharma industry today is that law fails to catch up with rapidly evolving pharmaceutical industry. For example, we face situations when effective pharmaceutical or treatment method fall into so called grey zone and neither is prohibited nor allowed. Therefore, such situations become a tool for the government to restrict particular business model. For example, we do not have a clear legislation when it comes to gene therapy, cannabis, novel food, etc. Latter reasons discourage business from investing in these industries.
ECPA'a expertise and experience sharing and deepening among the industry professionals can help in terms of uniting interested parties and drawing government’s attention to the most important issues for the industry."
What advice would you give to young professionals looking to build a career in compliance within the pharma industry?
"To establish a career in pharma compliance, young professionals should understand regulatory frameworks and keep up with industry developments. Additionally, acquiring strong analytical skills are crucial for success in this area. Lastly, it is important to understand that working in business requires creative thinking, how to ensure that certain activities comply with requirements of legal acts."
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