Revise WHO biosimilar guidelines urgently

Third World Network asks African civil society organisation to support its letter to the Chair WHO Expert Committee on Biologic Standardisation (EBCS) to revise the WHO biosimilar guidelines. The South African NCDs Alliance has signed.
The content below is from TWN.

In 2014, WHA adopted the resolution on access to Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy” (WHA 67.21).

It requests the Director-General: “to convene
t). the WHO Expert Committee on Biological Standardization to update the 2009 guidelines, taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities and to report on the update to the Executive Board
”. However, till date, the Secretariat has not updated the SBP Guideline.

WHO states that after the adoption of the  WHA resolution   “In April 2015, an informal consultation was organized during which participants from NRAs of both developing and developed countries, as well as from industry, recognized and agreed that the evaluation principles described in the Guidelines were still valid, valuable and applicable in facilitating the harmonization of SBP regulatory requirements globally. It was therefore concluded that there was no need to revise the main body of the existing Guidelines“.

This is a problematic approach and legally wrong. The resolution is clear and it asked the DG to convene the meeting of  WHO Expert Committee on Biological Standardization to update the Guideline and not to convene the meeting of  Expert Committee on Biological Standardization to decide whether to update or not. Further, the decision of  Member states cannot be overturned by the informal meeting of  National Regulatory Meetings. Further WHO has not published any verbatim records or minutes of the 2015 informal meeting. 

Poor management blamed for bulk of drug stock outs

Health Minister Dr Aaron Motsoaledi has blamed manufacturers for shortages of medicines including HIV and tuberculosis drugs, but a civil society coalition has alleged 80%of stock outs are due to poor management.

Community members have also complained about medicine stock outs.
In the Stop the Stock Outs Project’s latest survey, more than 40 percent of health facilities reported having experienced a HIV, TB drug stock out: Joe Gqabi and Alfred Nzo districts, Eastern Cape; Bojanala District, North West; Nkangala and Gert Sibande districts, Mpumalanga; and Lejweleputswa and Fezile Dabi districts, Free State.
According to Motsoaledi, recent reports by Times Live and eNCA regarding alleged widespread drug shortages promoted the minister’s early return last week from the World Health Organisation’s on-going, annual World Health Assembly in Geneva.

At a Pretoria press conference yesterday, Motsoaledi widespread shortages of drugs including the country’s three-in-one antiretroviral (ARVs) fixed-dose combination (FDC).

“The FDC is our flagship programme and we do everything in our power to protect it,” Motsoaledi said in a statement. “To make sure that there are not problems in this very important programme, we even implemented the practice of a national buffer stock whereby 10 percent of all the FDCs we provide are strategically stockpiled with a service provider in a warehouse.”

Motsoaledi also added that the county source the combination ARV from three different suppliers to guard against supplier problems affecting supply.

“At no stage did we have a shortage of FDC in the country,” he added.

As of September 2015, about 119,000 patients had been started on the FDC.

One in five facilities have experienced stock outs

The department recently released a list of at least 40 medications  -(comment by Vicki Pinkney-Atkinson  many of these critical for the treatment of NCDs, morphine and mental health medication)– that were running short at provincial depots nationwide. The department attributed the bulk of shortages to supplier constrained and shortages of the pharmaceutical ingredients used to make the drugs.

Stock outs of medicines are indicative of a bigger problem related to the management and accountability in a health system”

Comprised of civil groups including Medicines Sans Frontières, the Treatment Action Campaign and the Southern African HIV Clinicians Society, the Stop Stock Outs Project (SSP) collects stock out reports from health workers and clinics nationwide.

The group recently surveyed more than 2,500 of the country’s 3,732 health facilities. According to the research to be presented at the upcoming SA AIDS Conference, one in five facilities reported experiencing an ARV or TB medication stock out.

According to a SSP statement released yesterday, management or logistical challenges between medicine depots and clinics caused 80% of stock outs.

However, the group noted that patients were turned away without any medication in only 20 percent of cases.

“Supply of medicine to clinics and hospitals is the basic pillar to any public health system and stock outs of medicines are indicative of a bigger problem related to the management and accountability in a health system,” said SSP’s Dr Karl Le Roux in the statement.

The findings show an improvement over the group’s previous survey in which about one in four facilities reported stock outs.

However, >40% of health facilities in seven districts reported at least one HIV and TB drug stock outs. These districts include the Eastern Cape’s Joe Gqabi and Alfred Nzo as well as the Free State’s Lejweleputswa and Fezile Dabi districts. – Health-e News

Do you know of a stock out?

Email the Department of Health

or Stop Stock Outs sms or What’s App 084.855.7867 or email
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