Italy’s Draft WHO resolution: Improving the transparency of markets for drugs, vaccines and other health-related technologies

Posted on by KEI Staff

On 1 February 2019, Dr. Giulia Grillo, Italy’s Minister of Health, sent a letter to Dr. Tedros Adhanom Ghebreyesus, the Director General of the World Health Organization (WHO), with an attached “first draft” of a resolution on “Improving the transparency of markets for drugs, vaccines and other health-related technologies,” for discussion under agenda item 11.7 – Addressing the global shortage of, and access to, medicines and vaccines, during the 72nd session of the World Health Assembly (WHA) in May 2019.

The Italian Ministry of Health letter presented the resolution “with the aim to provide you, Director General, with an authoritative mandate to strengthen WHOs technical work on the transparency of the costs of research and development and the transparency of prices.”

The Italian proposal follows a long line of recommendations for greater transparency of the value chain for medical technologies, including the many outlined here:

Background-Transparency-15Feb2019

A PDF copy of the letter and resolution are attached here:

italy-letterWHO-DGTedros-resolution transparency

italy-draft-resolution-transparency-72WHA

The text of the draft resolution on transparency follows:

Attachment 1

Improving the transparency of markets for drugs, vaccines and other health-related technologies

Having considered the WHO roadmap on access to medicines and vaccines and the cancer report pursuant to resolution WHA70.12;

Recommends to the Seventy-Second World Health Assembly the adoption of the following resolution:

Concerned about the high prices for new pharmaceuticals, vaccines, diagnostic tests, and the unequal access and financial hardships associated with high prices;

Reaffirming the commitment of the Fair Pricing Forum to promote the transparency of research and development costs, production costs, prices, and profit margins of pharmaceuticals, vaccines and health technologies;

Noting the importance of public and private sector funding of research and development of pharmaceuticals, vaccines and other health technologies, and seeking to improve the transparency of investment flows and the costs for research and development for specific products;

Seeking to enhance the publicly available information on the costs of manufacturing of pharmaceuticals, vaccines and health technologies, and the patent landscape of medical technologies;

Noting with concern the limited public access to data from some clinical trials, including data on trials that fail, which reduces access to knowledge that is critical for advances in science and hinders appropriate scrutiny of trial design and the accuracy of reporting of such results, thus having direct and negative consequences for our knowledge about the safety and efficacy of medicines that are prescribed to patients;

Agreeing that policies that influence the pricing of health technologies or the appropriate rewards for successful research outcomes can be better evaluated when there is reliable, transparent and sufficiently detailed data on the costs of R&D inputs (including information on the role of public funding and subsidies), the medical benefits and added therapeutic value of products, and the actual access or lack of access to products by patients;

Seeking to expand access to manufacturing know-how for drugs, vaccines and other medical technologies in order to enable more competition from suppliers;

1. URGES Member States to:

  1. Undertake measures to enhance the transparency of markets for drugs and vaccines;
  2. Collaborate with other member states to create minimum standards for transparency regarding information from clinical trials and the costs of research and development for drugs and vaccines;
  3. Require as a condition of registration for drugs and vaccines annual reports on
    1. Sales revenues, prices and quantities,
    2. Outlays on marketing,
    3. R&D costs, including enrollment and outlays on each clinical trial separately, and
    4. Grants, tax credits or any other public sector subsidies and incentives relating to the development of the product;
  4. Avoid measures in trade agreements that limit transparency of information from clinical trials, legitimate disclosures of manufacturing know-how for drugs and vaccines, or the reporting of data on pharmaceutical, vaccine and health technology prices, revenues and other relevant medical or economic information;
  5. Improve the transparency of the patent landscape of medical technologies, using approaches that do not create barriers to generic competition;

2. REQUESTS the Director-General to:

  1. Collect and analyse data on health technologies of public health importance, including but not limited to:
    1. Actual costs of R&D on specific drugs and vaccines, including the enrollment and costs of individual clinical trials,
    2. Actual manufacturing costs of specific drugs, vaccines and health technologies,
    3. Manufacturing know-how, and
    4. The landscape of patents, including information about disputes about the validity and/or relevance of asserted patents;
  2. Collect and analyse data on clinical trial outcomes and adverse effects of health technologies;
  3. Create a web-based tool for national governments to share information on drug prices, revenues, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information;
  4. Create a web-based tool for governments and third parties to provide information on the landscape of patents on medical technologies, including information about disputes about the validity and/or relevance of asserted patents;
  5. Hold meeting to consider measures including but not limited to standards for reporting prices, revenue, R&D and marketing costs;
  6. Create a biennial forum on the transparency of markets for pharmaceuticals, vaccines and diagnostics, to evaluate progress toward the progressive expansion of transparency.