Increasing shortages of medicines discussed at WHO, to be continued in May
There is an increasing shortage of medicines in the world, in particular in developing countries, but not only there, World Health Organization members said in last week’s Executive Board meeting. Discussions are ongoing on potential solutions and the agenda item referring to the issue was left open, to be brought to the World Health Assembly in May.
A few days ago, the French Ministry of Health sought the commitment of pharmaceutical companies to address the shortage of vaccines in the country.
The 138th WHO Executive Board (EB) meeting took place from 25-30 January.
EB members considered a report [pdf] by the WHO secretariat on addressing the global shortages of medicines, and the safety and accessibility of children’s medication, as well as a draft resolution [pdf] proposed by China, Italy, Pakistan and Thailand. A separate group of countries, including South Africa and the United States, are working on another draft resolution, to be presented at the WHA in May.
Several countries taking the floor on 29 January said shortages of essential medicines are widespread and increasing in frequency, in particular in low and middle-income countries.
South Africa for the WHO Regional Office for Africa (AFRO) said it was supportive of the EB document and its proposed actions. However, the South African representative said, WHO should support member states so that they develop capacity, establish sustainable systems for tracking, gathering and sharing information, and to adopt medicine procurement approaches.
WHO, the delegate said, should develop and use market shaping for essential medicines, in particular abandoned essential medicines, and support the strengthening of local production of medicines.
She also indicated that a number of countries are working on a second draft resolution to be presented at the WHA in May. The United States confirmed it is among those countries.
Multiple Reasons for Shortages
Argentina said it is concerned about pressure being exerted by some producers who have monopoly patents and therefore do not use free market rules, and charge very high prices for the use of very sophisticated technology. This puts the health of populations and health systems at risk, the Argentinean representative said.
India said the reasons for shortages are multiple and vary among regions. Adequate attention is required on local manufacturing, market and non-market barriers to competition, regulatory issues, and supply chains dynamics. The role of public sector in ensuring access to essential meds and vaccines also needs to be explored further, the Indian representative said.
The WHO prequalification programme for drugs, in particular when there is a limited supply of active pharmaceutical ingredients, needs a relook, he said, explaining that shortage of such ingredients often results in shortages of end products and medicines.
The Zimbabwean representative said the document presented by the WHO secretariat “undermines the role of generic medicines and the impact they have played and continue to play in saving lives.”
Moreover, he said, “the document does not make a case for local or regional production of medicines,” adding that the role of WHO in supporting such production should be scaled up.
The document uses terms such as “stockouts” and “shortages” of medicines interchangeably, thereby interfering with clarity, the representative said. The document suggests that stock-outs lead to fake medicines (so-called substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products), he said, requesting that “such ambiguity in terminology and association be addressed.”
WHO Assistant Director General Marie-Paule Kieny confirmed that shortages are a global public health problem affecting low and middle-income countries as well as high income countries, and children’s medicines often face shortages. There are many causes for this, she said, including manufacturing problems, supply systems problems and fragmented purchasing.
In December 2015, the WHO convened an expert meeting to discuss the global shortages problem and formulated a series of actions to monitor, prevent, and manage shortages. Information gathered during this meeting will be added to the secretariat’s report going to the May WHA, she said, and will provide many of the elements requested by Zimbabwe.
The item was suspended with no decision. It is expected to be taken up at the WHA in May.
NGOs: IP, Production Issues Part of Problem
In its statement, Médecins Sans Frontières (Doctors without Borders – MSF) said when populations are faced with stock-outs or shortages of medicines, they are forced to buy medicines at higher prices from the private sector, or simply go without medicines they need.
“The major causes of shortages and stock-outs include production difficulties, such as issues with quality or an insufficient number of producers due to inadequate markets or intellectual property barriers, or decisions by companies to discontinue production,” the MSF representative said, adding that supply chain challenges and poor distribution were also among stock-outs and shortages causes. He added that governments “should use all intellectual property flexibilities to take action that can alleviate shortages.”
MSF suggested that the secretariat report’s scope be broadened to include “patented medicines whose shortages can be caused by monopolies, as well as all essential medicines, vaccines and diagnostics.”
A global database of critical medicines shortages should be established, with an early warming mechanism, he proposed. This was also suggested by some WHO members.
The International Pharmaceutical Federation (FIP), representing pharmacists, in its statement said it hosted an international summit on medicine shortages in Toronto in 2013 and made some recommendations. For example, FIP suggested that each country establish a publicly accessible means of providing information on shortages, that a global process to determine the list of critical and vulnerable products be developed, and that all procurers of medicines be urged to move towards active procurement processes that assure the continuity of supply of quality medicines.
Medicus Mundi International (MMI) in its statement said it welcomes the initiative to address shortage of medicines, but it should not be combined with the “equally important, but different issue of children’s medication.”
Like Zimbabwe, MMI also said that report conflates stock-outs and shortages. “Stock-outs are not absolute shortages but a failure to deliver existing medicines,” it said. “The report singles out shortage of ‘off-patent drugs’ and fails to recognize that shortages are often also caused by exorbitant prices of on-patent drugs too,” the MMI representative said.
French Health Minister Calls for Pharma Commitment
On 28 January, French Health Minister Marisol Touraine gathered pharmaceutical industries and obtained commitment to fight against vaccines shortages, according to the Health Ministry website (in French).
Shortages are both “insufferable and unacceptable,” said the minister, who said access to some vaccines had been “complicated” for several months for French citizens.
Pharmaceutical companies responded with several commitments. These include to: regularly communicate on vaccines stocks; set up, implement and communicate to health authorities shortages management schemes no later than 31 December 2016; continue to invest in the European Union to reduce production time, and increase capacity; and increase the volume of vaccines certified to meet security and quality requirements.
