In Brussels, the European Commission has tabled a proposal late in its term that would weaken the incentive to produce new medicines and the jobs that come with them. The change, under discussion at meetings this week in Brussels, would mean a shortened patent protection period for new medicines, allowing for copies to be produced by generic manufacturers for export to countries outside the EU.
Innovative new medicines are often granted an EU-wide intellectual property right, called an SPC ( supplementary protection certificate), which provides a five-year extension to the standard 20-year patent protection period that compensates manufacturers for the time and costs involved in discovery, licensing and authorisation. The European Commission proposal would remove the extension in significant cases. This, the industry believes, would weaken the incentive to innovate, to invest in and to discover new medicines.
Globally, more than 7,000 medicines are in development at any one time, with many of them manufactured in Ireland. These medicines have the potential to bring hope to patients and raise standards of living. To make one medicine can cost more than €2 billion and take up to 13 years. Not all medicines make it to market – just one to two of every 10,000 substances in laboratories pass all stages of development needed to become a licensed new product. So, the industry bears all the risk, as well as the cost.
To understand the importance of pharmaceutical innovation, we should look close to home. The development of statins revolutionised the treatment of cardiovascular disease. In a single decade in Ireland, the incidence of cardiovascular disease dropped by 28 per cent. Hepatitis C has virtually been cured by new medicines. The National Cancer Strategy aims to place Ireland in the top quartile of European countries for cancer survival in the next decade. With 73 per cent of survival gains in cancer attributable to new medicines, continued innovation in oncology drugs, as well as timely access to them, are key enablers for achieving the Government’s targets.
Ireland's foreign-owned pharmaceutical companies directly employ 30,000 people, with about as many more working in spin-off jobs. Over the past 10 years, the pharmaceutical industry has invested close to €10 billion in manufacturing and research sites around the country. Earlier this year, MSD announced that it will develop a new biotechnology facility in Dublin, playing a pivotal role in the manufacture of biologics-based medicines, including in immuno-oncology. Pfizer, another pharmaceutical manufacturer, is collaborating with Science Foundation Ireland on potential new discoveries in immunology, oncology, and cardiovascular and rare diseases. As a new report by EY-DKM for the Irish Pharmaceutical Healthcare Association shows, Ireland's attractiveness as a global investment location is enabled by an enterprise policy mix that supports innovation.
The challenge for Ireland is to continue to attract our share of the discovery and manufacture of innovative medicines, especially as more conditions require increasingly complex treatments, the population ages and rare diseases become more common. Ireland should aim to be a global player in unlocking tomorrow’s cures - through the likes of gene therapy, for example - with the right innovation policy environment and skills pool. Europe’s plan to weaken intellectual property rights, the scaffolding of innovation, will not help.
Ireland, and Europe, should be looking to strengthen our global scientific leadership. Our Government, supported by industry, has an important role to play in mitigating the effects of the European Commission’s proposals to weaken intellectual property rights through the SPC waiver. As the legislation is shaped in the coming months, we have an opportunity to ensure certain safeguards are built in, including that the waiver only applies for export to countries where there is no intellectual property protection or where it has expired, and that there be no scope for the retrospective application of the new rules.
It is vital that innovators’ intellectual property rights are not further undermined. If the structural engineering of innovation is allowed to weaken, the risk is that the strong pharmaceutical industry we have built in Ireland over decades will be set back. Worse, we could find ourselves at a competitive disadvantage globally when it comes to attracting new investment and research projects in the future. It is important that industry and government, both in Ireland and across Europe, champion the interests of innovators, patients and workers over the coming months.
Bernard Mallee is Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association