EU Commission meeting
Report from a meeting at the EU Commission
The EU Commission has been working on a revision of the EU pharmaceutical legislation for the last four years. The revision is said to be the biggest change in the pharmaceutical legislation in two decades. On May 10th, the EU Commission held a meeting at the Albert Borchette Congress Centre in Brussels for a «stakeholders dialogue on the pharmaceutical package».
I represented PHA Europe live at the meeting, and Wendy Vansteenkiste from the Belgium PH association participated online. There were a total of 44 representatives of both industry and patient associations present in the conference room. In addition, more than 100 people participated online.
Director General of DG Sante, Sandra Gallina, opened the meeting by giving a helicopter review, as she called it, of the revision. The current legislation is not working properly, she claimed, and listed some grand goals for the revised legislation:
1. Improved access for patients to treatments no matter where they live
2. A globally competitive EU pharmaceutical industry
3. Innovative medicines and treatments to address unmet medical needs
4. Stronger supply chains reducing shortages
5. More environmentally friendly medicines
EU hopes to achieve these goals with a combination of «carrots and sticks». The carrot for the industry is that their drugs will get increased regulatory data and market protection (meaning: before the drug goes generic) if certain criteria are fulfilled.
According to the current system, there is 8 years of regulatory data protection and an additional two years of market protection. One can also be granted one extra year for an addition indication. (If the medicine can treat another disease too.) So a total of 11 years.
In the revised legislation, the regulatory data protection is reduced to six year while the market protection and additional indication will be the same as before. So this is a total of nine years. However, the carrot is that if the drug is launched in all 27 member states, an extra two years of protection is granted. One can also be granted half a year extra if the medicine addresses an unmet medical need and an additional half a year if comparative clinical trials are conducted. So this gives a total of 12 years of protection. This could mean a lot of extra income for the pharma industry and is therefore considered a tasty carrot.
EU estimates an increased access of 15 % if medicine is introduced in all 27 member states. This means that 67 million more people in the EU could potentially benefit from a new medicine.
Regarding medicines for rare diseases, the carrot system is similar. However, the regulatory production periods can add up to even longer. The maximum will be 13 years while today the maximum is 10 years.
So by providing all these incentives, EU hopes that points 1, 2 and 3 from Gallina’s list will be fulfilled. This will bring a huge benefit to the patients. (And also those outside the EU region as new medication will be developed.) The benefit would probably also be sizeable to PH patients as PH is considered a rare disease.
EU’s stick is that they will enforce stronger regulations on the pharma industry when it comes to supply. This is thought to lead to less probability of shortages of medicine. Regulations will also make sure that medicines will be produced in a more environmentally friendly manner.
As part of the regulation, EMA will be strengthened and red tape reduced. This means that new medicines will hit the market earlier. Patients will also be invited to take part of the EMA process in order to increase patient involvement.
Focus has also been given to the development of new antimicrobial medicines. This is because of the AMR (Antimicrobials Resistance) issue that causes many yearly deaths in EU. The pharma industry has not viewed this marked interesting due to all the cheap generic medication available. However, if they develop new and more effective antimicrobial medication, they will be awarded with a voucher that they can use for other medication to increase the protection period.
Many of the representatives from the Pharma industry were very happy to hear about the reduction of red tape. «The patients and we have the same goal,» one said. «We want to bring new medicine to the market as early as possible.» However, one pharma representative expressed doubt if it was feasible to make medicine available to all 27 member states within the deadline given.
Many of the patient associations present welcomed the new revision of the legislation. They agreed that it would undoubtably benefit the patients. Many voiced different suggested changes, however. One that many expressed a concern about, was the fact that it is suggested that the drug information could be provided in digital format instead of today’s paper format. They were afraid that patients would not read it then, and it could be the cause of some very serious adverse effects.
There will be plenty of time to discuss the revision as it is not expected that it will be adopted before 2025 due to the MEP election next year. The EU Commission will now send the revision to the EU Parliament and Council for approval.
EPF, where we are a full member, was also present at the meeting. They will run an elaborate presentation of the revision on May 31st, the representative told me. I will distribute the invitation as soon as I receive it in order for you all to learn more about this important revised legislation.
Egersund, May 11th, 2023