The European Commission just closed a public comment period on a critical intellectual property protection that helps to drive discovery of new medicine. Specifically, the Commission is assessing supplementary protection certificates (SPCs), which can extend patent protection for innovative medicines that have faced lengthy regulatory approval delays. From the organizations diligent enough to complete the 96-page public comment submission over the holidays, there was clear feedback: SPCs are critical to patients, the economy and future innovation.
SPCs play an important role in supporting the development of innovative medicines. The Commission itself acknowledges that SPCs “provide sufficient protection for these products in the interest of public health and to encourage innovation in these areas to generate smart growth and jobs.” More specifically, SPCs:
- Help patients access innovative, life-saving medicines. Therapies on the market, and hopefully the more than 7,000 drugs in development, are able to reach patients through a strong intellectual property ecosystem that fosters and protects innovation.
- Support jobs and economic development. The biopharmaceutical industry directly employs nearly three-quarters of a million individuals in the EU, and indirectly generates jobs three to four times that amount, with an estimated €250 billion in pharmaceutical production in 2016.
- Maintain EU competitiveness in new drug development. The EU is a global leader in biopharmaceutical research and development, but its standing is at risk. According to IMS Health, the Brazilian and Chinese pharmaceutical markets both grew faster the EU in 2016.
Protecting and incentivizing innovation through SPCs and other measures is needed now more than ever. That’s because the research and development process for medicines has dramatically increased in scope, complexity and cost – requiring substantial resources over many years. To continue to innovate in this risky, resource-intensive process, researchers need the protections SPCs provide.
Despite the clear value SPCs deliver as part of an effective intellectual property system, the EU is looking to weaken SPCs. For example, the Commission is entertaining a “manufacturing for export” exemption that would allow generic and biosimilar manufacturers to produce and export products to countries with no SPC protection. Experts question whether such measures will deliver benefit, and moves to weaken intellectual property could have far-reaching, negative implications.
The Commission must reject “manufacturing for export” and look for ways to strengthen intellectual property incentives to ensure continued innovation – with new and existing products – as well as advance a robust innovation economy.
Our health care challenges are only increasing in complexity, and supporting innovation is our best chance to overcome them.