Successful collaboration between the public and private sectors

BRENDA COLATRELLA

B. Colatrella

OVER 16 years ago, in October 1987, before collaboration between the public and private sectors was common, Merck & Co., Inc.* launched the Mectizan Donation Programme (MDP). Through this Programme, Merck made a commitment to donate Mectizan (ivermectin) for as long as needed, wherever needed, to combat onchocerciasis (river blindness). Today, the MDP is a unique multi-sectoral coalition involving Merck, the Mectizan Expert Committee, WHO, the World Bank, UNICEF, national ministries of health, more than 30 NGOs and thousands of local community health workers. It is the longest-running donation programme of its kind, with active community-directed treatment pro-grammes in 33 of 35 endemic countries in sub-Saharan Africa, Latin America and Yemen. More than 30 million people are now treated annually. Although this Programme predated the Interagency Guidelines for Drug Donations, the Pro-gramme operates in a way that is entirely consistent with these Guidelines.¹

The disease

River blindness is a debilitating, disfiguring and often blinding disease. It is a leading cause of blindness in the developing world. The disease is transmitted by the bite of black flies that pick up and deposit skin-dwelling parasitic worms (microfilariae) into humans. Within infected persons, these microscopic parasites grow into larger, adult worms that live for approximately 15 years. WHO estimates that some 120 million people are at risk, while 18 million people are infected with the disease. Symptoms include acute, chronic skin rashes, constant itching and weight loss. The most severe effects of the disease are sight impairment and blindness caused by the colonisation of microfilariae in the eyes.^2,3

A breakthrough drug discovery

In the mid-1970s, scientists at Merck & Co., Inc., a US-based pharmaceutical company, discovered a compound called ivermectin. Studies showed that ivermectin was effective against a parasite found in horses that was closely related to the parasite responsible for human onchocerciasis. Together with WHO, Merck Research Laboratories conducted seven years of clinical trials to prove the drug's safety and efficacy in humans.^4,5 With one annual dose, Mectizan reduced the parasite load to near zero, helping to prevent further transmission and preventing blindness in the affected individual. At the time of the discovery, the highly successful On-chocerciasis Control Programme (OCP) was addressing the disease through aerial spraying with insecticide in West Africa. The discovery of Mectizan provided a powerful new tool for addressing this disease. With the closure of OCP and the spraying programme in 2002, Mectizan is now the primary tool for treating onchocerciasis worldwide.

A successful coalition

While Merck awaited formal regulatory approval of Mectizan, its management began to think about how to make the drug widely available. Those who needed it lived in poor, remote areas. Many of the countries hardest hit by onchocerciasis had inadequate health infrastructures. There were few if any medical personnel or conventional health systems to manage the drug's distribution and administration. There were also the challenges of drug importation regulations and customs duties. So simply giving the drug away was not a solution - yet abandoning it was inconceivable. A reliable, effective distribution system that would ensure Mectizan reached affected patients in 35 countries for more than 15 to 20 years was needed. In 1987, recognising that Mectizan was a very effective medication for onchocerciasis and that those afflicted could not afford such a therapy at any price, Merck decided to donate an unlimited supply of the drug for as long as necessary and to help create a reliable network for distributing the drug to those in need.

Faced with the enormous challenge of drug distribution, in 1988 Merck established the Mectizan Expert Committee (MEC) - a Merck-funded but independent committee of seven internationally respected scientists.^6,7,8 The MEC was charged with evaluating requests to use Mectizan in community-based treatment programmes, and assuring the widest possible availability of the drug while ensuring good medical practices were followed. MEC requirements for supplying the drug included a treatment plan approved by the ministry of health; an ability to maintain required medical records and to report adverse reactions; sufficient resources to sustain the treatment programmes for a minimum of 5 years; and agreement to integrate Mectizan into the existing health system wherever possible.

Regions endemic for onchocerciasis in Africa

In the early years of the programme, NGOs working in the area of blindness prevention in Africa acted as a catalyst for Mectizan distribution. Mobile teams served as a primary mechanism for drug distribution. As the programme progressed, field-level partnerships between national governments, NGOs, local WHO offices and the community were formed. In addition, a strategy known as Community-Directed Treatment with Ivermectin (CDTI) was championed by WHO and piloted in the delivery of Mectizan. Experience showed that communities, once fully informed, were capable of organizing, directing and managing their own treatment. The community exercises authority over decisions; it decides who should distribute Mectizan, how the drug should be distributed (for example, at a central place, house-to-house, at clinics) and when the drug is distributed. Today, more than 60,000 communities have responsibility and ownership for Mecti-zan treatment, thereby enhancing the programme's sustainability.

Working in close collaboration, Merck, the MEC, multilateral agencies, ministries of health, local and international NGOs, financial donors and affected communities have made the effort against river blindness a resounding success.

The Partnership's accomplishments

The most obvious achievement of these efforts is the benefit brought to the patients. Those with serious infections are spared from blindness, while those suffering from skin disease are provided relief from the chronic discomfort of itching, and the physical and sociological implications of skin discoloration and disfigurement. In addition, transmission of disease has been reduced and many premature deaths prevented. Thousands of cases of blindness are avoided each year. And in some countries, infection rates have dropped dramatically from over 50% to near zero.^9,10 The achievements of the Programme extend beyond these immediate health benefits. Economic benefits result from the agricultural development and resettlement of land freed from the disease. Communities benefit from the increased productivity of their members. Primary health care systems have been strengthened as additional health services are added to the infrastructure put in place for Mectizan delivery. Drug donation programmes and health interventions addressing other diseases have been formed as the MDP has served as a model for successful public-private partnership.

Figure 1. Number of Mectizan treatments provided for onchocerciasis: 1988 - 2002*

Lessons learned

The Mectizan Donation Programme has taught us many lessons about how to mobilise resources in public-private partnerships to address significant health problems. Among the major lessons learned are:

First and foremost, the MDP demonstrates that a drug donation must be appropriate, needed and accepted by recipients. While the MDP was established long before WHO published the Interagency Guidelines for Drug Donations, the donation of Mectizan is entirely consistent with the Guidelines. The lessons learned from the Mectizan experience have also helped to inform the Partnership for Quality Medical Donations (PQMD) and, more recently, the Partnership for Disease Control Initiatives (PDCI). PQMD is a coalition of pharmaceutical company and medical supply manufacturers and NGOs dedicated to raising the standards for drug donations globally (website: http://www.pqmd.org). PDCI brings together pharmaceutical company donors and their partners involved in drug donations for the control or elimination of specific diseases.

It is important to focus scientific and clinical research resources on feasible targets for important health priorities. Free drugs alone are not sufficient. Adequate, secure distribution mechanisms and health care infrastructure are essential in ensuring that medicines like Mectizan reach those who need them.

The case of Mectizan demonstrates clearly the power of strong, transparent, creative public-private partnerships needed to address complex health issues. Partnerships work best when based on clear objectives, trust, complementary expertise and mutual benefits. It is also essential that organizational and philosophical differences be embraced rather than ignored or rejected. It is these differences and the unique expertise of individual entities that create synergies - capable of yielding a total that is greater than the sum of its parts.

Even at their best, partnerships are challenging. They require continual communication, coordination and commitment from all stakeholders. They must be continually nurtured and adapted to reflect changing priorities and conditions to survive over the long run.

The MDP also demonstrates the importance of addressing sustainability at the outset. A commitment to ensure sustainability is as critical as the promise to supply a product. A key success factor was Merck's unconditional guarantee to provide Mectizan free-of-charge for as long as necessary.

The MDP also suggests that donation programmes should, wherever possible, be integrated into a country's primary health care system.

To enhance sustainability, partnerships must be informed by the needs of the people whose lives are directly affected. From the beginning, the approach taken to address this disease involved national authorities and local governments in endemic countries. The evolution of drug distribution to CDTI (discussed earlier) empowered communities and created a sense of ownership.

The cooperative nature of the MDP has also helped to build and strengthen primary health care in many countries. The delivery infrastructure and treatment strategies associated with Mectizan have resulted in the delivery of other health interventions and services, including Vitamin A, immunizations, the identification of cataracts, training of community health workers and the collection of census data. In fact, in 1998, Merck expanded the Mectizan Donation Programme to include the prevention of lymphatic filariasis in African countries where the diseases co-exist. The delivery and drug approval system established for onchocerciasis is now being used for lymphatic filariasis.

The Mectizan Donation Programme has helped millions of people in the developing world and now serves as a model of public-private partnership. Through the continuing efforts of this effective coalition, there is hope that onchocerciasis can be eliminated as a major public health problem and socioeconomic constraint within the next decade. The power of properly designed and executed partnerships - at the global, national and local levels - should not be underestimated.

Brenda Colatrella is Senior Director, Office of Contributions, Merck & Co., Inc. Tel: +908-423-2047, fax: +908-423-1987; e-mail: brenda_colatrella@merck.com

References

1. Guidelines for drug donations, 2nd ed. (Interagency document). Geneva: World Health Organization; 1999. WHO/EDM/PAR/99.4.

2. Onchocerciasis (river blindness), Fact sheet No.95. Geneva: World Health Organization; 2000. Available at URL: http://www.who.int/inf-fs/en/fact095.html

3. Taylor H, Pacque M, Munoz B, Greene BM. Impact of mass treatment of onchocerciasis with ivermectin on the transmission of infection. Science, 5 Ocober 1990, p.116.

4. Campbell WC. Ivermectin as an antiparasitic agent for use in humans. Annual Reviews of Microbiology, 1991; 45: 445 - 74.

5. Sturchio JL. The decision to donate Mectizan: historical background. Rahway, New Jersey: Merck & Co.; 1992.

6. Dull HB. Mectizan donation and the Mectizan Expert Committee. Acta Leidensia 1990; 59 (1 and 2): 399 - 403.

7. Dull HB, Meredith SEO. The Mectizan Donation Pro-gramme - a 10-year report. Annals of Tropical Medicine & Parasitology 1998, 92, Supplement 1 (1998), pp. S69 - 71;

8. Foege WH. 10 years of Mectizan. Annals of Tropical Medicine & Parasitology,1998; 92, Supplement 1: S7 - 10.

9. Benton B. The Onchocerciasis (River Blindness) Pro-gramme: visionary partnerships. World Bank Africa Region, Findings No.174, January 2001.

10. Hopkins DR, Richards F, Jr. Visionary campaign: eliminating river blindness. In: 1997 Medical and Health Annual. Chicago: Encyclopedia Britannica; 1997.

* Merck & Co., Inc., Whitehouse Station, NJ USA, operates as Merck Sharp & Dohme (MSD) in many countries outside of the USA.

Further reading on the Mectizan Donation Programme: Sturchio JL, Colatrella BD. Successful public-private partnerships in global health: lessons from the Mectizan Donation Programme, pp. 255 - 274. In: Granville B, ed., Economics of essential medicines. London: Royal Institute of International Affairs; 2002.