[Ip-health] Regional Committee for Europe - 69th Session - Statement of Italy - Matters arising from resolutions and decisions of the World Health Assembly

Thiru Balasubramaniam thiru at keionline.org
Fri Sep 20 04:17:11 PDT 2019

Regional Committee for Europe
69th session
Copenhagen, Denmark, 16–19 September 2019

Thursday, 19 September 2019

Matters arising from resolutions and decisions of the World Health Assembly

Communication from Italy

As you know, in May 2019, the WHA adopted a Resolution on the transparency
of markets for medicines, vaccines and other health products that was put
forward by Italy and then supported by a wide number of Member States,
including in the EURO Region.

The delegates who discussed the content of the Resolution during WHA agreed
that for a number of reasons we have to identify a new balance in the
market, one that can effectively address the need to develop products
meeting public health priorities (such as antibiotics) and on the other
makes all innovations available universally to their populations.

In this context, there is a significant risk of increasing inequalities in
terms of access to essential health products within and among Member States.

While we acknowledge the importance of differential pricing among Member
States, we strongly believe that improving the transparency of markets for
medicines is key to improve policy decisions, to increase competition and
therefore stimulate the development of functional and competitive markets.

Italy is committed to follow-up on the Resolution. Very recently, a Decree
of the Italian Minister of Health together with the Minister of Economy and
Finance updated the rules that regulate the negotiation procedure between
AIFA (the Italian Medicines Agency) and pharmaceutical companies requesting
the reimbursement of medicines by our National Health System.

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.

This new rules represent a first step that our Country has made towards the
implementation of the recommendation included in the WHA Transparency

We have also started working with some of the co-sponsors of the Resolution
and other Member States, including the Valletta Group of countries, to
discuss possible follow up actions. However, we strongly believe that any
meaningful step forward towards improved transparency can only be made by
working all together and cooperatively, designing a realistic and feasible
roadmap towards the final objectives through a step-by-step process.
Therefore, we encourage all Member States of the EURO Region to join these
efforts for increased transparency, which is critical to improve access to
essential medicines and health products towards the achievement of
Universal Health Coverage.

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

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