Italy’s AGCM Proposes Increased Public-Private Integration, Scrapping Laws that Prohibit Competition Among Biosimilars, Generics

Date: March 26, 2021 | Country: ITALY | Region: EUROPE | Type: Policy | Keywords: #agcm #aifa #biosimilar #classcdrugs #competition #galenicdrugs 
#generic #pricenegotiation #pricingandreimbursement #regulation #tender #wholesale

PRICENTRIC BRIEF:

  • President Roberto Rutischelli of the Italian Competition Authority (AGCM) has sent to Prime Minister Mario Draghi “Proposals for Competitive Reform,” which seeks to boost competition specifically in Italy’s pharmaceutical and healthcare sectors
  • The healthcare sector requires increased competition, should allow for second- and third-party players, and provide patients more choice when it comes to doctors—which could be achieved through public-private integration that leads to more satisfied patients without cutting healthcare spending
  • When it comes to drugs, Rutischelli said that intervention is needed to prioritize comparability between biologic drugs with the same therapeutic indications during tendering; allow on-demand negotiations for Class C “non-negotiated” drugs; remodel wholesaler policy with flexible quantitative thresholds to guarantee availability; remove restrictions on registration procedures for equivalent medicines ahead of patent expiry; and encourage the production of galenic drugs

 

THE DETAILS

ROME, Italy – President Roberto Rutischelli of the Italian Competition Authority (AGCM) has sent to Prime Minister Mario Draghi “Proposals for Competitive Reform,” which seeks to boost competition specifically in Italy’s pharmaceutical and healthcare sectors.

According to Rutischelli, there is an immense need “…for the adoption of measures that guarantee greater openness to access by private facilities to exercise health activities not affiliated with the national health service (SSN) and a more intense integration between public and private,” that “can, in fact, make it possible to better satisfy the growing demand for assistance and protection of citizens, without cuts in healthcare spending.”

The healthcare sector requires increased competition, should allow for second- and third-party players, and provide patients more choice when it comes to doctors. A public-private integration could help this proposal manifest, thereby leading to more satisfied patients without cuts in healthcare spending.

While Rutischelli details ways in which to accomplish the above proposal, he simultaneously highlights the need for reforms regarding drugs. Intervention is needed to prioritize comparability between biologic drugs with the same therapeutic indications during tendering; allow on-demand negotiations for Class C “non-negotiated” drugs; remodel wholesaler policy with flexible quantitative thresholds to guarantee availability; remove restrictions on registration procedures for equivalent medicines ahead of patent expiry; and encourage the production of galenic drugs.

To achieve these goals, Italy must:

  • Group together different active ingredients in the same batch, regardless of their differing therapeutic indications, if the Italian Medicines Agency (AIFA) has determined them to be equivalent from a therapeutic point of view
  • Strengthen the SSN’s negotiating position and encourage pharmaceutical companies to start and end negotiation quickly, and with a positive outcome, while guaranteeing the therapeutic continuity of patients
  • Ensure wholesalers provide the demand expressed by Italy’s regions so the right amount of medicines is guaranteed to be available
  • Repeal Italy’s law that makes the reimbursement of equivalent drugs contingent on the patent expiry of the reference medicine
  • Eliminate the requirement for makers of galenic preparations to autonomously produce the active ingredient necessary for the preparation when the ingredient is covered by a patent.

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