EU member states have adopted a controversial set of new measures governing the regulation of medicines at European level, following two years of deadlock and “unprecedented” lobbying by the pharma sector, particularly in Ireland.
The new laws will broadly reform the regulation of medicines and, critically, the issue of when to give generic drug makers access to clinical data, which tends to make certain medicines cheaper.
At a meeting of EU ambassadors in Brussels this morning, the so-called pharma package received overwhelming support, with Malta registering a sole abstention.
The package will now go forward for negotiation with the European Parliament.
Officials say the current upheaval in the United States, where thousands of staff from the Food and Drug Administration (FDA) have been fired, and where the Trump Administration has taken a hostile attitude to science and research, prompted a large number of member states to try to get the legislation over the line.
The pharma package had been deadlocked for over two years.
A key sticking point has been the length of the clinical data protection period.
Under existing rules, pharmaceutical companies have enjoyed an eight-year period during which rival or generic producers cannot access the clinical data related to authorised products.
The provision was intended to encourage manufacturers to invest in the EU by having a guaranteed period of sole clinical data ownership.
The European Commission’s initial proposal was to reduce the eight years to six, on the basis that producers of generic medicines could access the data sooner, and thus produce cheaper alternatives.
Under the original proposal, the patent holder could claw back two years by, for example, ensuring that trials were conducted in many member states.
Ireland initially leaned in favour of the six year approach but, following intense lobbying by the pharma industry, moved toward the eight year status quo.
Last month, Minister for Enterprise Peter Burke acknowledged that Ireland was shifting to the eight year protection period.
He told reporters in Brussels: “We really need to have innovation in that sector, because that will give people, ultimately, access to better health care, better medicines, and ensure that we are incentivising innovation and being at the cutting edge of medical developments.
“We have to get a balance between access to medicines, which is so important for citizens, but also to keep the pipeline strong so that we are at the cutting edge of innovation, and that companies have certainty as they go about developing new medicines. It is a balancing act.”
The Polish Presidency of the EU proposed a compromise text which would see the clinical data protection period remain at eight years.
There would be a further two years where for one year the pharmaceutical company would get an extra year of market protection and a second year whereby protection would continue if they carry out more trials in member states and if they produced certain kinds of medicines for an “unmet medical need”.
Officials say the text provides more reassurance for generic producers and will cut timelines for authorised medicines to get to market.
There are other measures, including making it easier to have multi-country and multilingual medicine packs, which should reduce production costs and make it easier to move medicines around Europe.
It is understood that Ireland regards the compromise as a balance between the need to ensure pharmaceutical companies continue to innovate and invest in European research, while providing access for generic producers and ensuring the production of safe medicines.
However, sources acknowledge an “unprecedented” degree of lobbying by the pharma sector, with representations being made to both the Taoiseach’s and Tánaiste’s offices, as well as to the Department of Health.
The legislation has been deeply divisive, with member states falling into opposing camps of those wanting to promote medical research in Europe and those more concerned about cheaper drugs for patients.
There are hopes that the final legislation could be adopted by the end of the year.
