Medical Value, Pricing & Patents

We have developed patent and pricing policies that have significantly improved access to all our products and especially HIV medicines, in the poorer countries that are home to around 87% of all people living with HIV/AIDS. These are designed to find a sustainable balance between:

• Offering our HIV medicines at the lowest possible price in poor countries in critical need, and
• Funding research and development into treatments for diseases that are still incurable, such as Alzheimer’s disease, diabetes, many cancers and HIV/AIDS.

Patents are society’s way of promoting innovation and encouraging progress in all industries. Creating innovative healthcare solutions through research and development is fundamental to our business. Clinical research is a costly and lengthy process, at an estimated 1 billion Swiss francs per drug and an average development time of 12-15 years. With so much investment required, and only one in every 1,000 compounds making it to the final testing stage, developing new medicines is a high-risk business.

As a result, pharmaceutical companies register patents on new drugs to protect their intellectual property. By being the sole manufacturer of a medicine for a limited period, companies can generate revenue from sales and recoup some of the substantial cost of development. However, patents are normally registered when a molecule is in early development, which may be many years before a drug reaches a patient. As a result, the length of time from approval when development costs can be recouped is around 8-12 years.

After the patent expires, the intellectual property related to the drug is publicly available and the drug can freely be produced by any interested manufacturer. This is another way that innovative healthcare companies can give something back to society.

Further information about Patents and the Roche Global Patent Function (PDF)

We understand that patents can be one of the many barriers to basic medical care in poor countries. This is why we do not file for new patents on any Roche medicines, for any disease, in the least developed countries (LDCs) defined by the United Nations (UN). Nor do we enforce existing patents in these countries. This means generic versions of any Roche medicine can be produced and distributed in the LDCs without applying for a licence.

Not all countries in sub-Saharan Africa, the region hardest-hit by HIV/AIDS, are defined as LDCs. Our policy is not to file patents on any new antiretroviral treatments for HIV/AIDS in the hardest hit region, sub-Saharan Africa, or enforce existing patents. Through our Technology Transfer Initiative, we also help manufacturers in these countries to produce generic versions of our HIV medication.

Counterfeit medicines and diagnostic products often look identical to authentic versions and are difficult to detect, particularly for patients. Counterfeit products do not just breach intellectual property rights - such as patent laws, trademarks, copyright, and regulator data protection - they are also a serious danger to human health. They can cause serious illness or death if they contain harmful ingredients or deprive patients of proper treatment.

Trafficking in counterfeit medicines and diagnostic products is widespread and affects both developing and developed countries.

The World Health Organisation published guidelines in 1999 on preventing and controlling drug counterfeits. Responsibility for this lies primarily with national governments and international organisations. Roche cooperates at both the national and the international level with regulators, police and customs officials. Our internal Anti-Counterfeiting Policy outlines what we do to prevent counterfeiting. Read our Global Statement on Counterfeiting for more detail.

Roche’s pricing policies are designed to provide sustainable access to medicines around the globe.

The cost of medicines and diagnostics is one of many barriers to treatment in the world’s poorest countries. Pharmaceutical companies are often criticised for the prices they charge compared with generic versions. Research-based healthcare companies like Roche have to cover the costs of discovering and developing the products, plus the costs of the many research projects that fail. Without recovering these costs through our pricing, we can’t fund research into new drugs and continue the fight against disease. However, through our no profit approach to two key HIV medicines, we are able to offer prices similar to or below those of generic medicines.

Price cuts alone are not enough to solve crises such as the HIV/AIDS pandemic. There are many other hurdles to be overcome to increase access to medicines in poorer countries, such as the lack of functioning healthcare systems and trained health professionals. Hence, Roche has established a variety of different programs to tackle issues such as basic infrastructure, education and medical training.

We supply our protease inhibitors Invirase (saquinavir) and Viracept (nelfinavir) at no-profit prices to the least developed countries defined by the United Nations and all of sub-Saharan Africa. This covers 63 countries, which are home to 64% of all people living with HIV/AIDS. These are the lowest prices at which the medicines can viably be sold in the long term and do not reflect research or development costs, marketing costs, distribution costs or company overheads.

We also supply the drugs at reduced prices in countries defined by the World Bank as low- or lower middle-income, where HIV/AIDS is a growing problem. In total, 87% of people living with HIV/AIDS live in countries eligible for reduced-priced Roche HIV medicines. We review our no-profit prices for HIV medicines annually and adjust them when necessary.