E-DRUG: single source drug donations
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["single source drug donations" are donations of patented drugs in contrast
to generic or "multi-source" drug donations; WB]
Pfizer's recent offer for free fluconazole for South African sufferers of
Cryptococcus Meningitis (CM) who cannot afford it, has been widely welcomed
as a positive step. But it also opens new questions as to under which
conditions such a project could work to
the benefit of public health:
- how long will Pfizer guarantee access to fluconazole? How sustainable is
the project? (people need lifelong prevention with fluconazole)
- who will have access to the free fluconazole? certain clinics/hospitals
only? public sector patients only? South Africans only?
- what protocol / standard operating procedures will be agreed upon? Is
that compatible with the national EDL/STG?
- fluconazole alone is not enough to treat CM patients: we will also need
training of health care workers, lab tests, diagnostic procedures, other
drugs and follow-up clinics etc (many of these are not free!)
- what quantity of fluconazole is needed? How many HIV+ people suffer from
CM?
Some have also indicated the possible 'political' ramifications:
- should we not rather pay an affordable price rather than receive a free
gift?
- did Pfizer want to avoid a Compulsory License for fluconazole? (A
compulosory license would have opened the SA market to other (generic)
suppliers of fluconazole)
- will Pfizer use the project to exert other pressures on the SA
government?
While the above questions will hopefully be answered in the coming weeks,
maybe we can learn from similar existing "single-source donation" projects:
- Ivermectin for river blindness
- Albendazol + ivermectin for filariasis
- albendazol for helminths (mass school programmes)
- Malarone for malaria
- Azithromycin for trachoma
Have any of the above projects been evaluated? What are your experiences
with them? Any other "single source drug donation" programmes that
E-druggers are aware of?
WHO has issued the following guideline for drug donations:
(extract from the July 1999 WHO Guidelines on interaction with commercial
enterprises)
"7.2. In determining the acceptability of large-scale donations of
pharmaceuticals, the following criteria should be met:
There should be sound evidence of the safety and efficacy of any drug in
the indication for which it is being donated. The drug should be officially
recommended by WHO for use in this indication and be approved in the
recipient country for use in the indication for which it is being donated.
It should preferably be on the WHO model list of essential drugs for that
indication.
� Objective and justifiable criteria for the selection of recipient
countries, communities or patients should be developed.
� A supply system should be in place and consideration should be given to
means of preventing waste, theft and leakage into the private sector.
� A training and supervision programme should be in place for all personnel
involved in the efficient administration of supply, storage and
distribution at every point from the donor to the end-user.
� A drug donation should not be promotional character, whether of the
company itself, or of a demand for the drug which is not sustainable after
the donation has ended.
� A phase-out plan of the donation should be agreed with the recipient
countries.
� A system for monitoring adverse events should be in place.
� Programmes should consult LEG with a view to negotiating and drafting an
appropriate agreement with the donor. Programmes should consult the
Department of Financial Services (FNS) with a view to determining the value
at which the donation will be recorded in WHO's financial records."
Your comments are appreciated!
Wilbert Bannenberg
(on personal title)
Email: WilbertBannenberg@compuserve.com
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