The Director General of the Italian Medicines Agency (AIFA) Prof. Guido Rasi and the Chairman Prof. Sergio Pecorelli, presented Italian excellence within the pharmaceutical field and the new quality and safety project with particular reference to generics, counterfeits and biosimilar drugs, during the meeting “The Italian Medicines Agency (AIFA) and Pharmaceutical Enterprises working together for the future of health”.
The meeting, which was also attended by the Executive Director of the European Medicines Agency (EMA), Thomas Lönngren, the Deputy Commissioner for International Programs of the Food and Drug Administration (FDA) Murray Lumpkin, the President of Farmindustria, Sergio Dompè was a constructive occasion of exchange between Regulators and Pharmaceutical Enterprises.
Our Agency – stated Prof. Rasi – is unique in that, due to its mandate both in drug authorisation and pricing and reimbursement, it performs benefit/risk assessment in parallel with the cost/effectiveness evaluation. Early access to safe and innovative drugs has to be achieved by combining the classic evaluation of efficacy, safety and quality of a pharmaceutical product, with Health Technology Assessment, to determine appropriate price and reimbursement conditions. To allow fastest possible access to innovative but costly drugs, for example new cancer drugs, conditional approval procedures have been developed, such as risk or cost sharing or payment by result. These tools are supported by Post Marketing data, obtained through dedicated registers, which allow the agency to reassess the place in therapy of these drugs at regular intervals in a reiteration of HTA.
Prof. Rasi also remarked AIFA’s commitment in the promotion of independent Research and Development, to introduce the new project of quality and safety of drugs, which “is based on the choice and selection amongst the latest technologies, such as mass spectrometry, MRI, HPLC, through which AIFA will proceed to the identification and validation of standardised methods, to be used in regulatory activity and in the fight against counterfeits”.
The importance of research was pointed out also by Prof. Pecorelli, who underlined how fundamental it is to apply science to the regulatory activity, and how it is crucial, also in the light of the recent changes due to the economical constrain, to re-define a shared, unique strategy. “The new molecular classification of diseases – Pecorelli added – necessarily entails a re-design of clinical trials, to better identify the most effective way to assess a new drug and assure a rapid access to the market.”
Prof. Pecorelli also positively commented the Drug Information Associaton’s role in promoting a valuable event such as the Annual meeting (to which AIFA takes part this year with two presentations and as exhibitor), that is fundamental for the exchange of experiences and different points of view between regulators and industry, “where internationalisation is the key-word”.
Health Technology Assessment was remarked upon also by the Executive Director of EMA, Thomas Lönngren, who expressed appreciation for the advanced experience of AIFA, and mentioned the need for a continuous dialogue between regulatory authorities and HTA bodies. The Executive Director further commented on the valuable contribution of AIFA to the work of Scientific Committees and Working Parties of the European Agency.
The Deputy Commissioner for International Programmes at the FDA, Murray M. Lumpkin, mentioned the Italian Medicines Agency as the first European regulatory institution to be approached by the then newly appointed Commissioner Margareth Hamburg for her first agreement on exchange of confidential documents. He further defined AIFA as the promoter of “diplomacy of health”.
The meeting was opened by a message from the Italian Minister of Health Ferruccio Fazio, who underlined the specificity of AIFA, which brings together the evaluation of risk/benefit profiles and of cost/efficacy of medicines, which are necessary for HTA activities in order to guarantee the sustainability of the National Health System.
Date: June 15, 2010
Source: Italian Medicines Agency
Filed Under: Drug Discovery