Pharma industry gets closer to Italian regulator
This article was originally published in SRA
Farmindustria, the Italian pharmaceutical industry association, has agreed a new method of dialogue with the country's medicines regulator, AIFA (Agenzia Italiana del Farmaco), to tackle key issues, including the backlog of applications and the quality of the agency’s regulatory work1.
"It is an important agreement. Farmindustria will be closer to AIFA in a very transparent way with precise indications on the work that needs to be done [...] Since we want the issues discussed openly with industry, this is a significant step," Farmindustria president Sergio Dompé told Regulatory Affairs Pharma's sister publication Scrip.
Sergio Dompé
Following a joint meeting on 25 November, AIFA and Farmindustria agreed to hold twice-yearly meetings preceded by quarterly technical meetings. The two parties will also set up joint working groups on key issues such as innovation, access to therapies and the introduction of AIFA's scientific advice service to companies. "It was a frank discussion with Farmindustria to address the problems in the most cooperative manner," an AIFA representative who attended the meeting told Scrip.
The backlog at AIFA affects applications for pharmaceutical export certificates, marketing authorisations and variations and Mr Dompé would like to see the agency increase the number of employees as well improve the "quality" of its staff.
AIFA for its part says that it has significantly reduced its backlog, and hopes to reduce it further by recruiting more people. The agency has some 330 staff (including contractors), but aims to have some 450 full time equivalents eventually. The first wave of new staff following a recruitment campaign started this week, something Mr Dompé welcomed. He noted that for export certificates the application timeline has fallen from up to six months to 30 days. For marketing authorisation applications, there has been significant improvement in timelines, he added. "We are not yet happy with this backlog but AIFA has really started to decrease it."
According to sources, the industry was concerned that AIFA wanted to start offering new services such "scientific advice" along the lines of that offered by the European Medicines Agency before it had put its house in order with the backlogs. These fears have been allayed somewhat now.
Mr Dompé says: "It is important we have scientific advice. We are happy with this move. For SMEs, this is a fundamental tool for them. We need to discuss ways [with AIFA] to move forward on this."
Scrip understands that AIFA did offer "scientific advice" in the past, but matters have now been formalised in this area. "We did not want to be diving into new activities until we had everything under control on our daily procedures," said one person who had been present at the meeting. "We started dealing with Farmindustria to improve the work we do and match it with their expectations," the person added.
Dual role
One of the joint working groups will look at "access to therapy". AIFA, unlike other EU member state agencies, has a dual role; as well as being a drug regulator, it is also a reimbursement agency. Mr Dompé says Farmindustria does not want to see a change in the methodology on how AIFA reimburses drugs, but that it is extremely important that there is transparency in its decision making.
On the dual role, he says: "I am not in perfect support of it. [However] if we are able to process adequately the [reimbursement application], and there is good [drug access] to patients, then it could be a solution that works." He is particularly keen for the 21 regions of Italy to start implementing the reimbursement decisions of AIFA on innovative drugs, removing delays to patients which have sometimes been as great as 1.5 years in some regions2. This is a move already backed by the ministry of health. "[The regions] need to take up AIFA's reimbursement decision immediately," says Mr Dompé.
References
1. Farmindustria press release, 27 November 2010, www.farmindustria.it/Farmindustria/html/publisher_doc.asp?title=Comunicati&menu2expand=elThree&table=publisherdoc&tablefields=publisherdocfield&tableattachment=attachment&tableattachmentservizioid=29&servizioid=30&newsid=775
2. Farmindustria press release, 19 November 2010, www.farmindustria.it/Farmindustria/html/publisher_doc.asp?title=Comunicati&menu2expand=elThree&table=publisherdoc&tablefields=publisherdocfield&tableattachment=attachment&tableattachmentservizioid=29&servizioid=30&newsid=774