The Irish Pharmaceutical Healthcare Association (IPHA) has urged industry and policymakers to work together to protect the intellectual property (IP) framework that spurs new medicines development.
The call comes as the world marked Rare Disease Day on February 28th – an annual event the draws attention to the experience of patients with rare conditions.
About 300,000 people in Ireland are affected by a rare disease. There are over 300 million people living with one or more of over 6,000 rare diseases around the world. About 72% of rare diseases are genetic and 70% of those start in childhood.
A disease is defined as rare in Europe when it affects fewer than one in 2,000 people.
IPHA called for the protection of IP rights which spur the development of new treatments and cures for unmet medical needs, including rare diseases.
Two IP rights are at risk under the European Commission’s recent Pharmaceutical Strategy – the Paediatric Medicines Regulation, adopted in 2007, and the Orphan Medicinal Products Regulation, adopted in 2000.
Under the Paediatric Medicines Regulation, over 260 medicines have been developed for children, with an increase of 50% in clinical trials between 2007 and 2016. Under the Orphan Medicinal Products Regulation, more medicines have arrived for rare diseases. In 2000, there were just eight orphan medicines. By 2018, that number had climbed to 164.
If these rights are weakened, new medicines development will slow, leaving medical needs, in both children and adults, unmet.
IPHA urged policymakers, in Dublin and Brussels, to join the industry in supporting innovators’ rights to the knowhow that drives scientific breakthroughs.
