Access to Medicines: The Novartis Approach

The issue of “access to drugs” cannot be discussed in isolation from overall deficits in development policies, health policies and systems, and implementation processes. It is a complex issue that clearly includes the price of drugs but also goes far beyond that.

As a rule, the combination of appropriate development policy, effective health policy, best practices applied in the health system, a rational use of drugs, and adequately funded health services can handle most of the health problems in any country.

Although public health care saves millions of lives from premature death due to disease and injuries, several well-known problems remain:

The key role for the pharmaceutical industry is to discover, develop, produce, and market innovative products to prevent and cure diseases, to ease suffering, and to enhance the quality of life. Intellectual property rights are the lifeline of the research-based pharmaceutical industry and are vital to sustain continued R&D into new treatments.

In view of the substantial investments of time and capital to bring a drug to market, as well as the high risk of failure, the research efforts of the pharmaceutical industry are primarily focused on diseases with potential for an adequate return on investment.

New mechanisms are therefore urgently needed to foster research on diseases of poverty. A combination of market-based incentives (“push” and “pull” mechanisms to reduce the research and development costs and provide the necessary financial incentives) together with increased public funding and public private partnerships are called for.

Another option is to create a Consultative Group on International Health Research that would administer a global fund, financed by multilateral and bilateral donors as well as by NGOs, along the lines of the Consultative Group on International Agricultural Research.

The impact of patent protection on patients’ access to treatment in developing countries is often exaggerated: Although about 90% of the drugs on WHO’s model list of essential drugs are available off-patent, over a third of the world’s population still has no access to these drugs. As essential drugs for the management of HIV/AIDS and drug-resistant forms of TB are patent-protected, and therefore the exception to the rule, innovative and unorthodox solutions must be found to improve poor people’s access to these treatments.

The pharmaceutical industry is willing to work together to developing sustainable solutions. Individual companies such as Novartis will focus their efforts on improving access to treatments within their specific product portfolios.

The challenge therefore is to integrate the emerging global health system of intellectual property rights into a workable solution to make treatments available to poor people. TRIPS (Trade Related Aspects of Intellectual Property Rights) aims to strike such a balance by providing intellectual property protection and allowing countries the flexibility to ensure that treatments are available for the poor in situations of national emergencies, such as the HIV/AIDS pandemic.

Special price arrangements that permit the adaptation of prices for individual products and countries also provide a solution as they combine incentives for research with a wider distribution of benefits. Various safeguards will have to be in place to maintain the structure of these differentiated prices, such as control over trade to prevent re-exportation to high-priced markets, undertakings not to use the low prices as reference prices in developed markets, etc.

Despite greatly reduced prices for treatment such as HIV/AIDS and malaria, given the scale of the disease burden, providing treatment for all patients will continue to be beyond the means of governments in developing countries.

Substantially expanding access to essential medicines, including anti-retrovirals, will require additional domestic and international financing for the purchase of the drugs as well as a significant investment in building effective health and supply systems. Without the infrastructure and capacity building necessary to administer the HIV/AIDS drug regimens adequately and effectively, there is not only the danger of sub-optimal therapeutic success but also the risk of resistance to anti-retrovirals.

The Global Fund to Fight HIV/AIDS, TB and Malaria has been established to translate the unprecedented international and political attention into real commitments that will help improve access to the information, goods and services that people so urgently need. However the financial commitment to date of US$ 3.4 billion is significantly lower than the budget of US$ 7—10 billion required to launch a global response in order to stop and reverse the HIV/AIDS pandemic alone.

Novartis is committed to helping improve patients’ access to its treatments for diseases of poverty. Novartis has signed two Memorandums of Understanding with WHO-one to provide Free Treatment For All Leprosy Patients until the disease has been eliminated from every country, and the other to provide Coartem®, its oral fixed-combination anti-malarial product, at cost.

Novartis is committed to supporting pro bono research on diseases of poverty. It has established a research center in Singapore which will focus on developing new preventive and effective treatments for tuberculosis and dengue fever. The diseases affect two billion and 50 million people respectively mainly in developing countries. The Novartis Institute for Tropical Diseases is a result of an agreement between Novartis and the Singapore Economic Development Board (EDB) and involves an investment of US$ 122 million. The center could become closely associated with a Consultative Group on International Health Research (CGIHR) which is line with the recommendation of the WHO Commission on Macroeconomic and Health.

Novartis will donate 100,000 DOTS treatments (Directly Observed Treatment, Short-course) for tuberculosis every year for a five year period as its contribution to the Global Fund The Novartis donation will be channeled through the Global TB Drug Facility and thus take advantage of existing structures and expertise in order to improve patients access to TB diagnosis and treatment. The donation will be provided to some of the poorest developing countries where it can make a significant contribution to improve the TB situation.

Since 2002 Novartis is providing prevention, diagnosis, treatment, and counseling services for its employees and immediate family members (nucleus family) for HIV/AIDS, TB, and malaria in developing countries. The programme is being scaled to cover all employees working in countries with insufficient health insurance.

Novartis is working out the framework of a programme, together with other partners, which aims at improving the access of poor communities in a sub-Saharan African country to comprehensive anti-malarial services (prevention and treatment) in a sustainable manner. Other partners could be the the Ministry of Health of the respective country, Swiss Development Cooperation, WHO, the World Bank, the Swiss Tropical Institute and Non-Governmental Organizations with competence in Access to Treatment issues.

Misallocation of public resources, in the sense of spending scarce resources on health interventions of low cost-effectiveness while underfunding critical and highly cost-effective health interventions;
inequity, in the sense that government spending intended to pay for basic health services for the poorest goes disproportionately to affluent segments of society; and
inefficiency, in the sense that health systems are often poorly structured and badly led, and their potential is squandered.