WHO reviews its Essential Medicines List; Some new candidates under patent

The 20th Expert Committee on the Selection and Use of Essential Medicines is meeting from 20-24 April. During an open session on 20 April, the WHO presented the selection process and the goals of its Essential Medicines List (EML) and several stakeholders provided comments and suggestions for the experts to consider during the week.

Kees de Joncheere, director, Essential Medicines and Health Products at WHO, chairing the open session [pdf], said the EML was created in 1977 as a list of medicines that should be available at all times at health facilities.

The Expert Committee has been meeting every two years to update the EML, he said. Important issues to be considered this week by the Expert Committee include the review of oncology drugs, and applications for new medicines such as hepatitis C and tuberculosis treatments.

The Expert Committee also will consider possible amendment to its work, in particular considering its growing agenda, and how to make the result of the committee work more accessible. The 2015 list is expected to be issued in the middle of next week.

The draft agenda of the Expert Committee this week is here [pdf].

Candidate Medicines under Patent

Gilles Forte, coordinator, Essential Medicines List Secretariat Medicines Policy, Access and Use Team (PAU)/Department of Essential Medicines and Pharmaceutical Policies (EMP) at WHO, explained that a number of drugs submitted for applications in 2015 are under patent.

In the past, some 95 percent of the drugs in the EML were generic medicines but it is anticipated that the EML might now include more innovative and patented drugs, he said.

The introduction of patented drugs in the EML raises pricing and availability issues, said Forte. Although WHO sees the importance of having those medicines in the list because of their efficacy, it acknowledges the challenge this can represent for countries. The WHO and its partners are discussing options that can be implemented at country and international level to address the problem, he said.

Nicola Magrini, EML secretary, PAU/EMP at WHO, said at its inception the EML included 208 active substances. At the last revision, this number reached 374 medicines, he said. There is an adult list with 374 medicines, and a paediatric list containing 278 medicines.

The selection process is based on: public health needs and disease burden; sound and adequate data on efficacy and safety; and comparative cost-effectiveness of available treatments, he said.

Applications can come from anyone. At least two reviewers express opinions on the candidate drugs, which are then brought to the attention of the Expert Committee, said Magrini. The Expert Committee holds plenary discussion and then makes a recommendation for inclusion, deletion or modification to the current EML. However, the final decisions rest with the WHO Director General, he said.

High Cost of Medicines, National Solutions

Magrini referred to a paper published by the WHO in March entitled, “Tough decisions on essential medicines in 2015.” In this paper, the WHO co-authors look at issues relating to the introduction of high-cost medicines for cancer, hepatitis C, multidrug resistant tuberculosis and new oral anticoagulants on the EML. Some 29 applications have been received for cancer drugs, Magrini said.

“Enabling access to cost-effective, yet potentially unaffordable, therapies will require particular consideration by the expert committee and new and better-coordinated actions at a global level,” the paper said. “Regional pooled procurement mechanisms, price controls, dedicated funding for specific needs, differential pricing and licence agreements can be effective ways of managing costs.”

Suzanne Hill, from the PAU/EMP at WHO, said the access problem for high-cost medicines is also affecting high-income countries, which have to allocate a large budget for high-priced drugs, taking from other health areas. However, she said, it is important to differentiate between price and cost, where price refers to the amount of money that is needed to acquire a good or a service and where cost is the amount of money that a manufacturer incurred to produce that good or service.

One of the criteria for selection of drugs to include in the EML since 2001 has been an assessment of cost effectiveness, said Hill. However, cost-effectiveness analyses are often missing information such as the source of the funding for the analysis, and the details of the appraisal models.

On pricing issues, she said the cost of production should be known, as well as what happens to the price over the course of the supply chain. The role of price controls in countries and of compulsory licences should be examined, she said, in particular the difficulties in using this particular option.

NGOs Call For Alternative R&D Funding, Generic Competition

The second part of the open session was devoted to interventions by non-governmental organisations.

Médecins Sans Frontières (MSF, Doctors without Borders), in its statement [pdf], said many obstacles are in the way of the optimal implementation of the EML, such as increasing prices, IP and other barriers to generic access, the lack of local registration, and questions of quality.

“Many new but extremely high-impact medicines are priced out of reach,” said Manica Balasegaram, executive director, MSF Access Campaign. He cited the example of sobosbuvir, used to treat hepatitis C virus, equally unaffordable in poor and wealthier countries, although priced differently in both settings.

He argued that tiered pricing, presented as a tool to facilitate access by multinational pharmaceutical companies, is merely a commercial strategy through which prices are “almost always substantially higher than prices available with generic competition…” It also leads to reduced access in middle-income countries, in which “approximately 75 percent of all people living in poverty currently reside.”

Balasegaram also said many medicines on the EML “are facing severe shortages and stockouts, or uncertain supply,” such as injectable penicillin, “despite their critical need in low- and middle-income countries.” This is caused by quality issues in active pharmaceutical ingredients, and also to the “lack of interest of manufacturers to invest in the development of such products which are no longer used in highly regulatory countries,” he said

Knowledge Ecology International in its statement [pdf] proposed that a category be created in the EML for products that would be essential, if available at affordable prices.

Cancer drugs that have been on the market less than 15 years and protected by patents have historically been excluded by the WHO, said Thiru Balasubramaniam, KEI Geneva representative, in particular because of their high prices.

“A policy to grant an IPR monopoly, through patents, data or other IPR mechanisms, is designed solely to induce investments in R&D,” he said, adding that countries such as India have regulated or eliminated monopolies over pricing concerns.

“Several countries and several health and innovation experts have proposed the elimination of monopolies for cancer drugs, and the creation of new ways of funding and rewarding investments in the development of new cancer drugs and diagnostics devices, relying upon combinations of grants and large, robust inducement prizes,” said Balasubramaniam.

In its statement [pdf], the Youth Commission on Essential Medicines Policies (YCEMP) said it is concerned that some of the proposed medicines are excluded from the EML on the basis of their current prices despite demonstrated efficacy, and safety.

The YCEMP representative underlined the difference between the prices charged for medicines under monopoly and the manufacturing cost, citing sofosbuvir’s estimated cost between US$68 to US$136 versus the price charged by the originator company, ranging from US$900 to US$84,000.

YCEMP urged the Expert Committee to take into account “various measures that can, and regularly do, secure generic competition, such as compulsory or voluntary licenses.”

“We urge this committee to ask why medicines are so expensive in the first instance and what these discoveries mean if patients cannot afford them,” she said, underlining “the need for new, collaborative and needs-driven mechanisms of drug research and development, predicated upon the principle of de-linkage…”

The Union for International Cancer Control (UICC) also read a statement [pdf] in which it said it convened a team of cancer experts to propose a new methodology for selection of systemic cancer therapies.

The IMS Institute for Healthcare Informatics presented the results of a study [pdf] of the role and use of the WHO Model EML. The study reviews the evolution of the WHO list and its implementation in nine countries (Brazil, China, India, Indonesia, Kenya, Malawi, the Philippines, South Africa, and Tanzania). The study was funded by the International Federation of Pharmaceutical Manufacturers and Associations, but “was undertaken independently,” IMS Executive Director Murray Aitken said.

In his statement [pdf], Aitken said the study found that the extent to which drugs included in the WHO EML are also included in country EMLs varies from 65 percent to 31 percent in the countries assessed. Newer anti-cancer agents, although not on the WHO EML, are included in some of the countries reviewed, he said.

“The WHO’s plan to review targeted therapies in 2015 is a positive step in potentially bringing these treatments to more patients,” he said.

Source: Intellectual Property Watch