With only a few weeks before unveiling the EU’s revamped framework for pharmaceuticals, Health Commissioner Stella Kyriakides described the main drivers of the much-awaited reform, stressing the importance of finding the balance between patients’ and industry’s interests.
The revised rules will offer “an opportunity to put patients at the centre, whilst at the same time fully supporting an innovative and globally competitive EU industry,” the EU’s health chief pointed out at an event on Monday evening (13 March) organised by the Austrian permanent representation and the European Health Forum Gastein.
The Commission’s initiative to reform the EU’s drug framework was expected by the end of last year, then was pushed back to mid-March and ultimately delayed again. However, Kyriakides confirmed that the proposal is now set for 29 March in a recent interview with EURACTIV.
During the event, she listed the six key aims of the upcoming proposal: ensuring access for patients, fostering innovation, addressing the shortage of medicines, improving the environmental sustainability in drug manufacturing, fighting AMR, and pushing simplification through regulatory modernisation and digitalisation.
According to Kyriakides, the reform was needed as “current rules were put in place in a different era and need to move with the times” in order to address “chronic challenges in this area” as well as solve problems “that have been highlighted by all for many years”.
“Our ambition is clear – to put forward a proposal that will be both patient-centred and industry-friendly,” she said. “These two objectives should be pursued in balance. Not as trade-offs.”
The head of the European Medicines Agency (EMA), Emer Cooke, who also attended the event, echoed Kyriakides’ words on the importance of patients’ involvement to help further patient centricity to balance the strengthening of the EU’s regulatory system for drugs.
How the EU will promote innovation in the sector remains an open question. “We will reward those who go the extra mile to provide EU-wide access,” said Kyriakides, acknowledging that, however, “herein lies the balancing act that we want to achieve”.
Vouchers for novel antibiotics
A bone of contention will be the new incentive system for the production of novel antibiotics to tackle antimicrobial resistance (AMR) – a silent killer that claims more than 35,000 lives per year in Europe.
“The need for us to get serious about AMR is obvious. Our pharma reform is the perfect vehicle and it will include measures both to stimulate new antimicrobial products, as well as prudent use,” said Kyriakides.
The Commissioner also seemed to back an idea put forward some months ago by the EU pharmaceutical industry to incentivise research and development (R&D) investment in the field of antibiotics.
The system works by giving the company that produces a so-called novel antibiotic a voucher to extend the marketing exclusivity of another one of their medicines, or they can sell the voucher to another company.
“We will propose transferable exclusivity vouchers for the development of novel antimicrobials to be granted and used under strict conditions,” anticipated Kyriakides.
Although backed by the industry, the system is contested by some stakeholders, including the EU’s consumer association BEUC, which recently warned in a policy paper that vouchers were “a big mistake” that would end up harming patients and markets.
“We are really not looking forward to the system,” Karla van Rooijen, director of the pharmaceuticals department at the Dutch ministry of health, said during the event, inviting the EU executive to “look at the other possibilities of options and be more transparent”.
Kyriakides added that the Commission will look into procurement mechanisms for access to new and existing antimicrobials that would guarantee revenue regardless of sales volumes.
EMA’s chief Emer Cooke said that “what we would like to see is not just more antibiotics but also more effective treatments that may not be antibiotics but could prevent the need for antibiotics”.
Addressing shortages
The reform is also expected to address shortages of medicines and boost the EU’s security of supply.
“There will be stronger obligations on supply and transparency of stocks. Shortages and withdrawals will have to be notified earlier,” said Kyriakides, anticipating that EMA will have a more decisive role in coordinating the Commission’s actions against shortages.
EMA’s Cooke recalled that only three years ago, her agency had no mandate on shortages as this was a national responsibility.
Then the pandemic came and changed the scenario, requiring a stronger involvement of the regulatory authorities – which is now expected to be extended to non-crisis situations in the new reform.
“I think the key to working with shortages is to make sure that we have transparency and understanding of where the challenges are, as well as a willingness to work together to make this happen,” Cooke concluded.
[Edited by Zoran Radosavljevic]
