Focus On Quality For Patients Saves Billions Of Dollars

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By Daniela Bagozzi

Ten years of progress in treatment have shown that ambitious health targets can be reached, thanks to global advocacy, increased funding for development and critical technical support to developing countries. Today, more than half of the people needing treatment for HIV are receiving it and quality malaria and TB medicines are more readily available. But there is still a long way to go – and as new health priorities emerge and funding shrinks, the poor in developing countries still struggle to secure quality treatment.

The WHO Prequalification of Medicines Programme (PQP) prequalified the first generic AIDS medicine in 2002 in a move that proved crucial for access to medicines in the developing world. Until then, triple antiretroviral therapy, the only way to keep the virus at bay and assure a longer lifespan for HIV-infected people, had been priced at an average US$ 12,000 per person yearly – equal to 12 years’ income for the average sub-Saharan African.

By prequalifying a product by the Indian generic manufacturer Cipla, WHO ensured that people could begin to access the same medicine for as little as US$ 350 per year. With time, more and more generic products were found to comply with WHO standards of quality, and as more producers were prequalified, the prices of crucial medicines to treat AIDS were slashed further.

Jonathan Quick, who headed WHO’s Department of Essential Medicines from 1996 to 2004, sees the legitimation of generic medicines as the turning point in AIDS treatment access. “There’s no way we could have treated over 8 million people without generics,” he said in a phone interview.

“Quality assurance made generic competition possible,” he said. “Competition coupled with high-volume purchases by PEPFAR and the Global Fund has brought the annual cost of AIDS medicines to under  $ 100 – 1% of what it was in 2000.”  In just six years of procuring AIDS medicines for PEPFAR, Dr Quick’s current organization, Management Sciences for Health, has saved over one billion dollars, primarily through generic procurement.

By galvanising wider acceptance of generics and stimulating lower prices, WHO has played a crucial role in introducing medicines that are better adapted to developing country requirements, such as paediatric medicines and combination therapies. Fixed-dose combination pills (several pills in one, which are indicated for better therapy compliance and delayed drug resistance) were first prequalified by WHO in 2003, three years ahead of the US FDA. Most of these medicines are generic.

In spite of progress, WHO identifies serious quality challenges that continue to prevent access to treatment. An immediate concern is the quality of reproductive health products. Reproductive health is an integral part of the global gender equity agenda and is seen by development experts as crucial to maternal health. In spite of a number of family planning summits, political support and donor pledges to scale up access to contraceptives, numerous reproductive health products in use do not meet international quality standards, with potential risks ranging from mild side effects to infertility and death.

According to Lembit Rägo, the technical mind behind the Prequalification Programme, the reason why AIDS treatment scale-up worked was that everyone, from countries to civil society, UN agencies and health NGOs were on the same page about the need for affordable quality medicines.

“That cohesive striving for a common public health goal gave us the space to do some sound quality work with manufacturers and developing country regulators,” Rägo said. “Today, with shifting priorities and less money for health, the focus on quality is dimming and the poor pay.”

A similar problem is emerging with neglected tropical diseases, which account for roughly 11% of the global disease burden. “Aid agencies are not pushing to supply these medicines, so there is little incentive for manufacturers to apply international quality standards and compete for donor funds,” explained Jacques Pinel, former Coordinator of the Research Group on Essential Drugs at Médecins Sans Frontières.

Another crucial health area for the near future is noncommunicable diseases, such as cardiovascular conditions, cancer, asthma and diabetes. As these take a bigger toll on developing countries, availability of affordable quality medicines will pose a challenge potentially resulting in a proliferation of substandard medicines as more patients seek treatment. In addition, with less money to invest in local capacity building, developing countries could be left hanging with weak regulatory mechanisms and less external assistance.

“The international community’s universal health coverage agenda, including ‘good quality medicines for all’, is still a long way away from reality,” concluded Dr Rägo.

Daniela Bagozzi is a former UNDP, WHO and UNITAID communicator now working independently on global health and development.

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