by Robert Galbraith
ROME, Feb 13 (APM) - Italy is to forge a pharma alliance to create a more effective and efficient regulatory system to ensure patients have sustainable and cost-effective access to new treatments, according to the country’s health minister Beatrice Lorenzin.
Addressing a meeting after an official visit to Bristol-Myers Squibb’s production centre at Anagni, south of Rome, the minister identified pharma as one of Italy’s biggest and most successful industries which has increased production and exports despite the severe economic recession.
Italy is the second largest producer of medicines in Europe after Germany and it could become a world-beating industry though improved regulatory infrastructure and a more prolific alliance with government, the Italian health minister told the meeting.
Lorenzin stressed the need to create an efficient and attractive market for companies selling their products in Italy. She suggested the health system and its drugs budgets were created for conditions that existed 20 years ago. They need to be adapted and modernised to meet the new demands, she warned.
Medicines agency to hire 250 more staff
Lorenzin credited Italy’s medicines agency AIFA for much of Italy’s progress. She cited very positive comments on her travels abroad as testimony of its advanced approach to drugs assessment and monitoring. She said this gives companies producing in Italy invaluable support because their drugs are seen to be of the highest standards.
However, she stressed the need for the agency to be significantly expanded if it is to take on the increased workload foreseen in a more dynamic Italian pharmaceutical market. Currently only 450 people work in its offices much less than counterparts in the U.S., Sweden, the U.S. and elsewhere.
She said its systems are not always fit for purpose, citing the example of a scientific board which only meets once a week. This is not conducive to a smooth and quick authorisation process, she suggested.
The main priority is therefore to boost numbers at AIFA to make the regulatory process faster and more efficient. She said a measure is to be included in legislation already going through parliament allowing AIFA to hire 250 more qualified staff immediately.
Fast track authorisation procedure not working, will be fixed
Lorenzin admitted Italy’s fast track for innovative drugs is not working and promised this will be addressed shortly. A law was passed in August 2014 requiring AIFA to complete pricing and reimbursement procedures within 100 hundred days of the European Medicines Agency (EMA) authorising innovative or orphan drugs (APMHE 35189
The health minister blamed delays at AIFA and regional obstacles for the fact that it can take 200 or 300 days for innovative therapies to be available. She said: “We have an ethical responsibility to get drugs to patients quicker and we will make sure that happens.”
Lorenzin committed Italy to providing certainty in the rules and regulations and its drugs spending and promised the time needed to have products authorised will be competitive with other markets. She stressed how this will help companies operating and producing in the country, to compete globally.
Italy to boost clinical research, reverse brain drain
The minister identified Italy’s main weakness as the lack of pharma R&D. She said the research system is closed and fragmented. However, the number of talented scientists working abroad and making interesting discoveries suggests Italy could be an important player.
Italy needs to create critical mass of clinical research and to reverse the brain drain which has seen many of its top scientists leave, the minister said. Creating a dynamic pharma R&D sector could increase GDP by as much as 2%, she predicted.
Hepatitis C treatments 'extremely cost-effective’
On the costs of new hepatitis C drugs, Lorenzin said the 1 billion euros of special funding provided was an unprecedented step. She described the new hepatitis C treatments as “extremely cost-effective” estimating that a patient who needs a transplant will cost the national health service up to 500,000 euros over the long term.
But she warned governments do not budget on that sort of time scale and it is therefore difficult to pay for the upfront costs. “If I could present a plan to eradicate hepatitis C over the next one or two years, it would be accepted and funded immediately. But when it is a 10-20 years programme, it is impossible. That is why the 1 billion euros special funding was so exceptional,” she explained.
Lorenzin argued that payers and industry need to build a partnership where both sides are working towards providing access to new drugs.
BMS chief welcomes Italy’s ‘new attitude’
Roberto Tascione, BMS’ CEO in Italy, welcomed the minister’s comments. He was very positive about the “new attitude” in government towards pharma. “For the first time we have a commitment to not cutting drugs budgets,” he said.
He believes an alliance with payers can be built. “At BMS, we are very open to alternative ways to make available new drugs to patients in a sustainable and cost-effective way,” he told the conference.
Tascione described the dialogue with government institutions and agencies as vital to his company’s provision of new drug therapies. He said: “We hope the (company’s) extraordinary immunotherapy oncology drugs can be made available to Italian patients and we are ready to help find ways for them to be introduced with adequate funding and according to fixed programmes.”