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Zingaretti: "The agreement between 5 Regions for the purchase of medicines is revolutionary". ANMAR: "No to state drugs"

“The agreement stipulated also by Lazio to purchase drugs with tenders called by five Regions together is revolutionary and will save us a total of 31 million euros, 10 of which only for our Region. This is an example of how savings can be made by making the administrative machine more efficient and how for us the spending review corresponds to innovating, not cutting performance”.

This was the statement made yesterday by the president of the Lazio Region, Nicola Zingaretti (pictured with Canton),  on the occasion of the inauguration of the Center for Phase 1 Clinical Studies of the Ifo, Regina Elena and San Gallicano in Rome, at which he spoke together with the Undersecretary of Health Armando Bartolazzi.

Phase 1. Volunteer. Healthy. Phase 2. Patient. Phase 3. Enlarged. Phase 4. Post-marketing. Objectives: to provide evidence of efficacy and tolerability of the drug to the Regulatory Authorities; provide information on how to optimally use the drug. Double-blind, randomized, controlled clinical trials with active comparison. Large, multi-center clinical trials involving several hundred to thousands of patients.

Zingaretti wanted to underline how the exit from the commissioner is experienced by the Lazio Region  “without being lazy either in the field of management or in that of research, but instead by raising the quality of care and trying to attack the most complex nodes of health care. Today, with the Ifo, a very important leap forward is made in research in collaboration also with the pharmaceutical industries for research that is useful and close to patients”.

It was its director general who spoke about the new ifo centreFrancesco Ripa Di Meana,”The Center for Phase 1 Studies, which acts as a bridge between pre-clinical research and human research” has explained “adds a central piece that completes the Institute's experimentation offer. The investment to equip our Institute with a large public center at the disposal of the pharmaceutical industry and, in the future, of the non-profit network was important. The ultimate goal is to make Rome, with all its research facilities, a platform for the global competition for the development of new drugs for oncology and dermatology in Italy and around the world".

At the Ifo in 2017, there were 335 active clinical studies, of which 126 were more properly experimental, called interventional, and 194 observational. While 76 studies have already been evaluated by the ethics committee in 2018. The volume of clinical activity that allows patients to be candidates for studies is important: 26,000 first visits to the experimental oncology clinical department, in addition to over 68,000 controls and 18,500 chemos; instead, over 48,000 were the first visits and about 26,000 checks carried out by the Clinical Experimental Department of Dermatology.

Ref Day – 31 October 2018

Related news: “No to regional downward tenders”. Rheumatic patients (Anmar) write to Mattarella to protest against "state medicines"

Biosimilars. From Anmar sues against unknown persons for switches from originator to biosimilar

Cricket: Stop waste and evaluate the cost-benefit of free NHS care

The Regional Council of Piedmont boasted the achievement of significant savings with a supra-regional tender for a biological drug (see http://www.regione.piemonte.it/pinforma/sanita/2402-alleanza-fra-5-regioni-per-acquistare-un-farmaco-e-prezzo-ridotto-del-65.html). Savings to be reinvested within the NHS are welcome: the question is how.
In the crudity of the numbers, perhaps the press release foreshadows a forced replacement of therapies for all patients being treated in the Piedmont Region?
Is it a coincidence that the slightest mention is not made of the choice of doctor and the patient's consent?

Differently from what other Regions do and differently from the principles expressed in the 2017 Budget Law, the Piedmont Region has decided to award only one drug: the state or regional drug. This says a lot about the reduction of fragmentation and inequality.

(from the Letter from ANMAR to President Mattarellto)

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco