[Ip-health] Italy undertakes bold measures on transparency by adopting the Pricing and Reimbursement Decree

Thiru Balasubramaniam thiru at keionline.org
Mon Aug 10 10:51:38 PDT 2020


https://www.keionline.org/33696

Italy undertakes bold measures on transparency by adopting the Pricing and
Reimbursement Decree
Posted on August 10, 2020 <https://www.keionline.org/33696> by Thiru
<https://www.keionline.org/author/thiru>

On Friday, 24 July 2020, Italy officially published the
long-anticipated Pricing
and Reimbursement Decree
<https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario;jsessionid=oALQlvya4vzVBh3UAs5xVg__.ntc-as2-guri2a?atto.dataPubblicazioneGazzetta=2020-07-24&atto.codiceRedazionale=20A03810&elenco30giorni=false>
in
the Gazzetta Ufficiale della Repubblica Italiana setting in motion Italy’s
place as the first country to implement the WHO transparency resolution
<https://www.keionline.org/29721> (WHA72.8
<https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf>).

In statement
<http://lists.keionline.org/pipermail/ip-health_lists.keionline.org/2019-September/023120.html>
before
the WHO EURO regional committee in September 2019, Italy described the key
features of the Pricing and Reimbursement Decree including mandatory
requirements on the disclosure of public contributions to R&D, patent
transparency, and the provision of annual reports regarding sales data,
revenues and marketing expenses.

The Decree includes some important aspects related to transparency. In
particular, the pharmaceutical companies seeking reimbursement from the
National Health System, are requested to provide information on marketing,
sales and reimbursement in other countries, including negotiated prices.
Moreover, information should be provided with regard to public
contributions and incentives received on research and development (R&D)
programs, as well as clear and up to date information on the patent status
of the concerned medicinal product. Finally, the pharmaceutical companies,
as part of the final agreement for medicines reimbursed by the National
Health System, will be obliged to provide annual reports regarding sales
data, revenues and marketing expenses.

Dr. Luca Li Bassi, former Director-General of AIFA (the Italian Medicines
Agency) was the architect of this historic decree. He provided KEI the
following perspectives noting that transparency can serve as an effective
tool to promote solidarity and collective action in the COVID-19 response.


   “The need for more transparency in the pharmaceutical markets was
   already felt as a priority by all delegations at WHA72 but has become even
   greater during the pandemic. It’s only through sharing information and data
   that we will collectively learn how to best fight this virus and find
   effective therapies and vaccines to reverse its course and save lives. The
   cooperation and solidarity advocated now by many global health institutions
   can only occur through the transparent sharing of knowledge and information
   for the benefit of humanity.


   This is an important reform for Italy as the old rules dated back almost
   20 years. This Decree will now put AIFA in a much stronger position to
   negotiate reimbursement levels based on more solid analysis and
   evaluations. I am also confident that other countries will take it as an
   example to implement similar steps, or possibly more, towards the full
   implementation of the WHA Resolution.”

The publication of the Pricing and Reimbursement Decree in the Gazzetta
Ufficiale della Repubblica Italiana will give immediate effect to the
decree.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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