My Papers Pharmaceuticals Regulation

The Role of Intellectual Property in the Biopharmaceutical Sector

That is the title of an FTI White Paper published this year where I was a co-author alongside Antoine Mialhe, Sabiha Quddus, Anne-Sophie Deman, Suhail Thahir and Agnes Sipiczki.

The role of Intellectual property (IP) in the development of COVID-19 vaccines and therapeutics became a central tenant in discussions on how to ensure access to medical countermeasures globally. In response to criticisms around vaccine manufacturing and scale-up, some policymakers have suggested that overriding IP rights are one way to expedite COVID-19 vaccine production and distribution. In contrast, others claim that production and distribution would be further delayed without solid IP protections. In the context of this fast-moving political debate, FTI Consulting supported INTERPAT, a non-profit biopharmaceutical consortium, and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in developing a White Paper and peer-reviewed article on the role of IP in the biopharmaceutical sector. The white paper developed by FTI’s team comes at a crucial time and provides concrete evidence that can inform European and global political debates on IP, COVID-19, and international trade.

Key takeaways from the white paper include:

  • Intellectual property plays an enabling role in many industries, and it is the lifeline of the biopharmaceutical industry
  • Intellectual property protection is the cornerstone of drug discovery and development and stimulates an innovative environment in the life sciences sector
  • Intellectual property protection fosters a culture of collaboration in the health sector, which played an instrumental role in the record-breaking pace of COVID-19 vaccine and therapeutics development
  • Robust intellectual property protection leads to considerable long-term benefits for patients, employees and broader society. Conversely, a reduction in intellectual property protections would have significant negative impact on the life sciences sector investments in research and development and by extension, on society
  • The global intellectual property system has created an environment conducive to the development of medical technological advancements, fostering trust needed for manufacturing scale-up

Of particular interest from the health economics side:

To model the impact of a potential change in the current intellectual property regime, our study assesses what the impact of overriding intellectual property rights for 10% of drugs would be. We find that:

* Under this scenario, the long-term loss in societal welfare would be worth USD 214.5 billion per year on average, equivalent to 0.2% of global GDP.

* Additionally, patients would bear 70% of the harm due to fewer new drugs being developed in the future to treat existing diseases

You can read the whole report here or an Executive Summary here.