Just In: What the EU Needs to Know About Incentivizing Innovation

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:

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.