PRIVATE PATENTS AND PUBLIC HEALTH

The problem of counterfeit medicines surely needs to be addressed, but
no one really knows how big a problem it is. 197 Emphasis on counterfeiting as
the main threat to public health can prevent attention to a more serious
issue: assuring the quality of medicines. A group of medicines supply experts
at Médecins sans Frontières identified this problem as long ago as 2008. 198
The experts concluded that the best way to tackle the problem of substandard
medicines is through assistance to manufacturers to help them improve
pharmaceutical quality. They listed other ways to assure medicines quality:
control of exports of substandard medicines, including from industrialised
countries; strengthening health systems in developing countries; and having
donors and purchasers enforce quality requirements in calls for tender.
Access to effective medicines that meet international quality standards
depends on several factors, often interrelated:
• Affordability (often related to patent status);
• Secure and reliable supply chains;
• Quality suppliers; and
• Producers that meet international standards.
PRIVATE PATENTS AND PUBLIC HEALTH
Donor policies are key to increasing access to quality-assured medicines.
The Global Fund quality assurance policy, adopted in 2009 and then taken
up by other donors, ensures that its resources are used to procure medicines
approved for use by Stringent Regulatory Authorities 199 or prequalified by the
WHO Prequalification Programme (PQP; see Box 2, “The Quiet Revolution at
the WHO”). This policy has important implications. It strengthens drug
authorities in their efforts to limit the infiltration of fake medicines and to
boost and maintain quality-assured production. As a result, the number of
generic manufacturers producing drugs that meet quality standards will
likely increase, assuring wider availability of affordable, safe, and effective
generics. There are now, for example, 16 triple FDCs to treat HIV/AIDS
prequalified by WHO and priced at US$ 100–136 per patient per year. 200
Over 80% of the antiretroviral medicines used in treatment programs in the
developing world are accessed through international procurement bodies,
mostly sourced from Indian generic suppliers, and mostly prequalified by the
WHO or by a stringent regulatory agency. 201 Despite the savings and health
benefits the WHO PQP creates, the programme continues to struggle to find
a sustainable financing base for its work. It is considering a fee-based model,
which could jeopardise its independence. 202
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