Regulatory Open Forum

The Indian multinational pharmaceutical company Cipla has a rather "provocative" and "in your face" vision statement which states “None Shall be Denied”. In this general audience post on New Year’s Eve, I ask if we can make "None Shall be Denied” a global pharma New Year’s Eve resolution for 2017 onwards. I also share a few thoughts about the role public-private partnerships could play to advance global health initiatives.

Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the WHO’s 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best.

Public-private partnerships have already helped address some of the world’s largest public health challenges. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children’s Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution.

In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings.

Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound “libraries”, and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a “Patent Pool” for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy.

Similarly, the Indian pharmaceutical company, Cipla, whose vision statement is “None Shall be Denied” was at the forefront of providing affordable combination anti-HIV therapy in the developing world. In 2001, Cipla introduced the world’s first ever recommended 3-in-1 fixed dose anti-HIV combination in Africa at a price of less than $1 per day, compared with the prevailing price of about $33 per day in many countries. This effectively lifted the “death sentence” for millions of persons with HIV in developing countries. Lest we forget, HIV was not always a chronic and manageable disease. In the early years of the AIDS crisis, it was an acutely fatal illness even in developed countries. However, in my view, Cipla’s affordable drug pricing and "compliance enhancing" 3-drug fixed-dose combination would have been less effective without partnership of local governments and NGO’s. Today, almost one million persons with HIV take affordable antiretrovirals made by the Cipla alone, thus allowing them to lead a near normal lives.

We now have evidence that by leveraging what each party know how to do best, partnerships involving the public and private sectors can successfully pave the way for better outcomes for the 1.7 billion citizens of developing countries who need treatment for neglected diseases. Najib Babul, PharmD, MBA