Intellectual property must be safeguarded to ensure ongoing breakthroughs in innovative medicines

Posted on April, 26 - 2019

On World IP Day, pharmaceutical innovators say it’s vital that the intellectual property (IP) rights that enhance the development of innovative medicines in Europe are protected and not further eroded.

According to the Irish Pharmaceutical Healthcare Association (IPHA), which represents the research based pharmaceutical industry, driving research and development to fuel innovation and address areas of unmet medical need, must be underpinned by a robust IP framework.

There are currently over 7,000 medicines in development. This new wave of medical innovation and the products it will bring would simply not exist without pharmaceutical incentives and rewards.

“Unfortunately, this framework for innovation has been eroded at EU level due to the adoption of a draft regulation allowing for an SPC manufacturing waiver”, IPHA Chief Executive Oliver O’Connor commented.

“It is ironic that as we mark World IP Day, the environment for the discovery and adoption of medical innovation has been weakened, potentially putting at risk the development of new treatments and high-quality jobs at the frontiers of research”, he added.

In February the European Council reached a political agreement on the SPC Manufacturing Waiver, which will allow the manufacture of generic and biosimilar medicines in the EU for export and stockpiling during the period of extended patent protection provided for by the EU. As EFPIA, which represents the industry at a European level commented at the time, this development is a “gamble with the future of innovation”. The adoption of amendments on two-year stockpiling, a very early implementation date and weakened safeguards, is of concern.

“The great fear is that stockpiling without adequate safeguards risks the erosion of IP rights beyond the waiver itself. This could be perilous for the future of innovation. Without innovation there would be no new cures. At EU and domestic level, it is imperative that the IP framework is not further undermined. Patients deserve no less”, concluded Oliver O’Connor.

Notes for Editors

Supplementary Protection Certificate (SPC) (1992)

Introduced in 1992, the SPC extends exclusivity for a pharmaceutical product that is protected by a patent to compensate for part of the time lost during the lengthy development period before a medicine can be made available on the market and ensure sustainable funding for such research.

Draft regulation on SPC Manufacturing Waiver

In February the European Council reached a political agreement on the SPC Manufacturing Waiver, which will allow the manufacture of generic and biosimilar medicines in the EU for export and stockpiling during the period of extended patent protection provided for by the EU.