WHA Resolution For Transparent Drug Pricing: Italy Speaks Out

Italy’s Minister of Health spoke out publicly today at a press conference in Rome on the proposed World Health Assembly resolution on drug price transparency, while an open letter published on the Ministry’s website called on other World Health Organization member states to support the initiative.

Italian Minister of Health Giulia Grillo with Manlio di Stefano Italian Ministry of Foreign Affairs (Right to Left)

The resolution would help end “deplorable asymmetries of access to information about many aspects of the innovation and supply chain for medicines, vaccines and other health technologies,” said the letter, that was sent last week to all 194 WHO member states and over 200 leading NGOs.

Entitled “Improving the transparency of markets for drugs, vaccines and other health-related technologies,” the resolution, to be discussed at the 72nd session of the WHA, asks national governments to demand greater price transparency as part of regulatory processes and also gives WHO a clear global mandate to track and compare drug prices nationally and worldwide.

“Without transparency in the pharmaceutical market there can be no real competition,” Minister of Health Giulia Grillo told reporters at the press conference in the Ministry’s Rome headquarters, broadcast live on the Ministry’s YouTube channel.

She said getting a handle on drugs costs through greater transparency is critical to the “sustainability” of public health services such as Italy’s National Health Service, adding “The markets must not fear change in this direction that is increasingly necessary. Citizens ask for it, for whom access to care remains the primary need, and is essential for the future of our health systems.”

Grillo was flanked by Foreign Undersecretary Manlio Di Stefano and the General Director of the Italian Drug Agency (AIFA) Luca Li Bassi, as well as Undersecretary of Health Armando Bartolazzi – reflecting the united Italian government front on the contentious transparency issue.

Grillo noted that there had been numerous, “fragmented” initiatives on the issue, including a Transparency Directive issued by the European Union in 1988, “which unfortunately never achieved the transparency objectives.” However, the issue “has never been addressed with a systematic and common approach internationally. For these reasons I have therefore sent this resolution proposal to the WHO, which will be discussed in Geneva during the next World Health Assembly, from May 20 to May 28,” she said.

“The draft resolution I sent to the WHO stems from the need to tackle the issue of lack of transparency in the pharmaceutical sector and in particular how to arrive at price formation,” the minister continued.

An open letter to WHO member states, signed by more than 100 civil society advocates and published by the Ministry on its official website, stated that the current lack of information “creates confusion about basic facts related to prices, research and development costs and other aspects of the value chain for medicines, vaccines and health technologies.”

The proposed resolution would “create a work program for the WHO and norms for governments to cooperate in improving the transparency of various aspects of these technologies,” said the open letter dated March 6, which was signed by over 80 NGOs as well as 20 leading individuals active in research and policy-making on the issue.

“This is a critical time for governments to consider reforms in pricing and incentives for innovation for health technologies. The transparency measures proposed in the resolution will ensure that consideration of such reforms will be based upon the best possible evidence,” the letter concluded.” We urge your government to support the resolution.”

Italian Medicines Authority and Italian Ministry of Health call for greater drug price transparency in national media.

The WHA resolution proposed by Italy would mandate WHO to:

  • collect and analyze data on the results of clinical trials and on the adverse effects of drugs and other health technologies;
  • provide governments with a forum for sharing information on drug prices, revenues, research and development costs, public sector investments and research and development subsidies, marketing costs and other related information;
  • provide crucial information on patent issues.

At the press conference, Grillo said that costs of medicines and other treatment therapies is an international as well as national issue, that is burdening both health systems worldwide – regardless   of whether they are predominately public or private systems.

“There is absolutely a need to intervene on this and join forces worldwide,” she remarked.

Di Stefano, of the Ministry of Foreign Affairs, noted that while drug prices were stressing the comparatively well-funded public systems of countries like Europe, in countries of Africa, the high costs of many medicines left systems unable to provide treatment at all. He cited his experiences working in the Democratic Republic of Congo as an example.

“Sometimes we take it [access to medicines] for granted, because we were born raised in a country that has a health system,” he noted. “We are protected from my point of view.”

Di Stefano added that access to affordable medicines was central to principles such as the “right to health” and that such rights needed to be backed by concrete, practical actions. As a result, he said, Italy was mustering the diplomatic initiative to “outreach” towards other countries: “We are looking at all forums for dialogue – with the support of a government that puts rights at the centre.”

Excepts of Key Statements from the Press Conference

Below are key statements made at today’s press conference transcribed and translated into English by Health Policy Watch. The Italian Ministry of Health verified the accuracy of these statements.

Giulia Grillo, Italian Minister of Health

  • Transparency is a necessity, it is a necessity on all fronts, from having complete information on clinical trials, and onwards. The cost of medicines is a national issue and an international theme that all countries of the world face.
  • It is a problem for the sustainability of public health services but also for private systems as we have seen in America. We had the same drug for hepatitis C (HCV) that was € 40,000 (in Europe) and had come to $ 80,000 (in the USA) so in fact the cost of drugs concerns systems that are supported by private financing,  and certainly those supported by public funding like those in our country are affected even more.
  • We have seen what other countries are doing too. There is absolutely the need to intervene on this issue and to join forces worldwide.
  • We see other [developing] countries have less negotiating power and therefore have less capacity obviously to be able to impose themselves on the giants of the pharmaceutical industries.
  • As you know there will be a session within the World Health Assembly in Geneva between 20-28 May where the possibility of adopting this resolution will be discussed.
  • We are doing the preparatory work, and we will see if the consensus on this resolution in May will be reached at the meeting in Geneva. We obviously will be really happy and honored to get a result. We are aware it will be complex; however, we have the support of the Ministry of Foreign Affairs to help us take action through the Italian diplomatic network.
  • If we manage to have some guarantees on the part of the pharmaceutical companies about some information on the formation of the price – this will be to the advantage of all countries – it allows us the possibility of making policies that today, even if you want to, you will not succeed [in developing].
  • The fact pharma companies include the confidentiality clause, affirming that there is no need for comparison. It seems to me in few words a little ridiculous: you have to convince me that it is better to continue to make me pay as much money as possible and then I won’t care about comparisons either.
  • We say we need to have available data because we want to do the right thing, rather than paying incorrectly the price of a drug.
  • We have tried to talk with the pharmaceutical industry dozens of times on this issue but there was a lack of willingness to negotiate.

Luca li Bassi, General Director of the Italian Medicines Agency

  • At present, we have missing information in terms of pharmacological information, clinical trial information – and there is no way to compare drug prices.
  • 30 billion Euros are spent in Italy on drugs a year [both public spending and out of pocket].
  • We need a data-based registry with the European drug authority noting quality, efficacy and safety of new drugs, as compared to the options that already exist.
  • [In terms of precedents] We start from a directive of the European Union dating back to 1988 calling for an adequate level of transparency in the life cycle of the drug, and even more recently in 2017, the European Parliament called to update this directive in view of the importance of the issue. In practice it has been raised not only at European level, but also at the global level by WHO itself and by other bodies such as the OECD. For example in the OECD report of 2018 there was a section dedicated to the importance of having transparency in the life cycle of drugs.
  • [through the WHO resolution] We want to improve our ability to make international-level comparisons and that should be a benefit for all, including industry. Benchmarking would stimulate global competition (on drug production and prices), creating greater efficiencies.
  • The current situation has created a level of information asymmetries that must somehow be rebalanced, so we can make the best of public spending not only at the [national] Italian level but at European level.
  • There is a need to have complete information not only on the results of clinical studies and at the scientific academic level, but at the international level. We need to have a complete picture of  the value of a drug, the current risks and benefits that each medicine can bring, in a comparable way.
  • Part of the financing for drugs comes from investments made by every Member State – and therefore we contribute to the development of this market, and we are important stakeholders.We must be able to have a complete picture.
  • We need a more appropriate balance in terms of symmetry of information.  We all believe in having a competitive pharmaceutical market at a global level and without transparency we will never be able to achieve this goal.
  • Confidentiality clauses cover about 57% to almost 60% of all hospital drugs. It is impossible to keep going on the way we have been.

Manlio Di Stefano, Undersecretary of State, Italian Ministry of Foreign Affairs

  • The Ministry of Foreign Affairs is available for this topic of importance and has already activated its whole diplomatic network with the Permanent Mission of the United Nations in Geneva. But now it will be very important to make a healthy positive outreach towards other countries.
  • We talk about the right to health, but we don’t have the guarantee that right to access is respected. Sometimes we also take it for granted, because we were born and raised in a country that has a health system.  We are protected; having seen a large part of the rest of the world [as a diplomat], I believe that openness to citizens must be implemented.
  • Basic access to the medicine one of the essences of a health system. I saw with my own eyes [while working as a diplomat] in the Congo where it was impossible to get certain medicines because the national health care system lacked the economic resources.
  • We must return to concrete practical discussion of the resolution. We are looking at all forums for dialogue – above all with the support of a government that puts rights at the centre. We have the opportunity today through the resolution that the Minister submitted to the Director General of the WHO at the beginning of February, to act as catalysts on these very heartfelt issues and bring them to some concrete results.

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