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Programmes in Least Developed and Developed Countries

Least developed countries: Playing an active role

Many of the world’s poorest countries lack even the most basic healthcare and the infra-structure required to support it. As well as medicines, they need the infrastructure and health professionals to ensure the right diagnosis is made and the right medicines get to the right people.

Often people living in these countries lack the basic knowledge and skills to combat the spread of preventable infections, including HIV/AIDS. With an estimated 38 million people living with HIV/AIDS worldwide – close to two thirds of these in sub-Saharan Africa – finding ways to provide sustainable healthcare is essential.

Roche’s primary role is to develop new and improve existing medicines and tests. But we also implement programmes to increase access to our HIV medicines for people living in the poorest countries (those defined by the United Nations as the least developed, plus other sub-Saharan African nations not already in this list).

Our strategy is to:

  • Have clear patent and pricing policies for our medicines rather than donating products
  • Build partnerships with governments, NGOs and other committed parties
  • Continue research and development into new and existing HIV/AIDS medicines
  • Promote education, training and knowledge sharing
  • Donate technical expertise to local service providers and manufacturers.

Our combined expertise in diagnostics and therapeutics means we can help poor countries make the most of their limited resources. We concentrate on improving access to basic healthcare. Read about some of our key access programmes:

  • The Technology Transfer Initiative is increasing the capacity to manufacture HIV/AIDS treatment in the most affected countries
  • Through AmpliCare, Roche Diagnostics helps doctors in the world’s poorest countries to test and monitor patients with HIV/AIDS
  • The CARE Programme aims to make HIV/AIDS treatment sustainable by strengthening local health systems and training African healthcare workers
  • The Cambodia Treatment Access Programme provides access to essential care for people living with HIV/AIDS
  • The Phelophepa Health Care Train provides much-needed basic health care to communities in rural South Africa.

The Technology Transfer Initiative

HIV/AIDS is being tackled effectively in many countries, but sub-Saharan Africa remains the region hardest hit by the disease, with around 24.5 million people affected.

Access to first-line HIV/AIDS treatments (which Roche does not produce) is increasing in the poorest countries. But the virus replicates quickly and often mutates, becoming resistant to first-line treatments over time. As a result, the need for second-line treatments such as Roche’s HIV protease inhibitor, saquinavir, will continue to grow.

As part of our ongoing commitment to increase access to HIV medicines and to address the growing need for second-line treatment, in 2006 we launched the AIDS Technology Transfer Initiative.

The Technology Transfer Initiative is designed to help companies in countries with limited resources to manufacture generic versions of HIV medicines. This increases local capacity to provide treatment and reduces reliance on wealthier nations. We do this by sharing our know-how of manufacturing saquinavir and providing hands-on guidance to local manufacturers in sub-Saharan Africa and countries defined by the United Nations as ‘least developed’ – 63 nations in total.

A dedicated Roche team spends much of its time sharing knowledge and skills at local manufacturers’ production facilities. We review requests from manufacturers on a case-by-case basis, working with companies that have the manufacturing capacity and capability to reach the right levels of quality and efficacy.

This is different from other access initiatives in that rather than just provide a licence or information we work on-site with the local company on a continuous basis in order to share our expertise face to face, to provide the right support and guidance when needed and to develop their manufacturing capabilities towards global standards. Local manufacturers who want to produce generic saquinavir for use in the least developed and sub-Saharan African countries do not need to apply for a voluntary licence, as we do not register or enforce patents on our antiretroviral medicines (ARVs) in these countries.

If you are a manufacturer and you are interested in producing generic saquinavir, please contact the TTI project manager at our global headquarters in Basel, Switzerland.

AmpliCare

Diagnosis and monitoring are as essential to effective HIV/AIDS treatment as medicines. The earlier a diagnosis is made, the better the results of treatment. Doctors also need to monitor the progression of the disease so they can prescribe the most effective treatment and make adjustments if their patients’ viral load increases. This is because HIV replicates very quickly and often mutates, becoming resistant to first-line treatments over time.

Roche Diagnostics’ HIV viral load test, which measures the amount of the virus in the blood stream, has become the gold standard for monitoring the efficacy of HIV treatment. The AmpliCare initiative is making these important diagnostic and viral monitoring tests available in the countries most affected by HIV/AIDS, along with education programmes to support the use of tests and treatment.

AmpliCare began in 2002, and supplies HIV viral load tests at the lowest possible price in sub-Saharan Africa, South America and the ‘least developed countries’ defined by the United Nations. Roche Diagnostics works in partnership with international agencies, local communities, hospitals and the William J. Clinton Presidential Foundation to create a programme that provides far more than just diagnostic tests.

AmpliCare works with major government and private programs to support and expand existing efforts in each region. Through AmpliCare, local authorities and hospitals have built and equipped laboratories, trained lab workers and diagnosed and monitored their patients. An education programme trains local doctors and nurses to carry out viral load testing with limited resources, and keeps them fully informed about the latest advances in HIV/AIDS care.

We plan to extend AmpliCare to all the countries most in need, with a focus on least developed countries. The aim is for AmpliCare to bring access to HIV testing and monitoring in line with access programmes for HIV treatment worldwide.

CARE Programme

HIV/AIDS is one of the most serious global health crises. Almost 40 million people worldwide are living with the disease. Roche has a number of initiatives and policies for improving access to HIV/AIDS treatment in the world’s least developed countries. Finding ways to make treatment programmes sustainable is essential, as people with HIV need lifelong care.

We believe the best results come from public-private partnerships involving companies, governments, international organisations and the people affected. Roche has been working in partnership with the PharmAccess Foundation on a seven-year programme to help tackle HIV/AIDS in sub-Saharan Africa – home to almost two thirds of those affected. The CARE programme (Cohort programme to evaluate Access to anti-Retroviral therapy and Education), which began in 2001, was an important step in this direction.

CARE was developed to evaluate the impact of HIV treatment and education in Africa. At treatment centres in four countries – the Ivory Coast, Kenya, Senegal and Uganda – patients who had previously had no HIV treatment received antiretroviral therapy. Counselling and education programmes have helped increase knowledge and awareness of the disease among patients and medical staff – a critical element of making treatment programmes sustainable. Experience exchange and training events have helped hundreds of African health workers – including many not involved in CARE – to increase their skills, share experiences and learn from one another.

CARE has shown that providing free, comprehensive clinical care to HIV/AIDS patients in countries with limited resources can have similar success rates to treatment programmes in the developed world. Findings from the CARE programme and presentations from CARE conferences are available online so that all those involved can access them.

Cambodia Treatment Access Programme

Launched in September 2003, the Cambodia Treatment Access Program (CTAP) is a public-private partnership between the Cambodian Ministry of Health, the National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales, Australia, and Roche. Cambodia is thought to have the highest rate of adult HIV infection in Asia. CTAP aims to increase access to essential treatments for HIV/AIDS and provide training for local healthcare professionals.

As part of CTAP, a new outpatient treatment centre for patients with HIV/AIDS has been opened in Cambodia’s capital, Phnom Penh. The centre provides counselling, clinical care and HIV therapy, and supports HIV training and research. By 2006, CTAP had enrolled more than 1,200 people for free treatment thanks to Roche’s support. In September 2006, Roche funded a training event for 400 healthcare professionals from all over Cambodia to expand their knowledge and share experiences of treating HIV/AIDS.

In recognition of the impact CTAP has had on HIV/AIDS treatment, the Royal Government of Cambodia presented the programme’s founding partners with an Award of Recognition, the highest distinction for such a contribution. Cambodia has constantly improved its HIV/AIDS care and is one of very few countries which exceeded the treatment target set by the World Health Organisation for 2005. Recent figures show that the HIV infection rate in Cambodia is now in decline.

Phelophepa Health Care Train

The Phelophepa Health Care Train is a mobile clinic bringing medical care to rural South Africa, where there is just one doctor for every 4,000 patients. Roche is Phelophepa’s main sponsor and has provided funding since the train took its first journey in 1994.

The name Phelophepa is derived from two different South African languages and means ‘good, clean health’, although patients frequently call it the ‘train of hope’. Phelophepa has 16 coaches and is equipped to supply general, dental, eye and psychiatric care. The train provides primary care only, as it covers such a large area it visits each place just once every two years. Staffed by 14 health professionals and 40 student volunteers, each year the train

  • Travels South Africa for 36 weeks
  • Covers an average distance of 15,000 kilometres
  • Treats around 40,000 patients
  • Serves over 60,000 meals.

Phelophepa’s achievements to date are impressive. With support from Roche, the train has reached out to over 13 million people – including women and children who would otherwise have no access to basic medical services. One of the things that make the service so effective is that it provides much needed basic health education to people in the community, including traditional healers.

Roche has increased its financial commitment to the project over the years, enabling the provision of several new services such as cancer screening and diabetes prevention. Recent studies predict a sharp rise in the number of people with type 2 diabetes in South Africa, making this a valuable addition to the train’s services. Cancer screening is also important, as African women are often unaware that breast lumps can be malignant.

Developed world programmes: Tackling inequality in wealthy nations

Healthcare needs in wealthy nations are very different from those in developing countries. People are generally healthier, and suffer from different types of disease that require different kinds of treatment. The quality of healthcare and the infrastructure that provides it is much higher. Most people can afford the care they need, and are well provided for by either public or private healthcare systems.

We sell our products and services in more than 170 countries, and the majority of patients have access to them through doctors, pharmacies and hospitals. However, there are still a number of people who cannot afford the healthcare nor the health insurance, and fall through the gap. Hence, we have implemented a number of programmes to assist with access.

Clinical trials

We provide free medicines and testing to patients involved in our extensive clinical trial programmes. This often includes any additional treatment and testing to those being trialled. Where necessary, we continue to provide our drugs free of charge after the trial until the product is commercially available.

Over 7,000 hospitals and clinics worldwide are compensated for each of their patients taking part in a Roche trial. This money is often used to fund additional nursing staff, educational centres and research that otherwise would not be possible. In addition, Phase IV (post-approval) trials allow clinicians to become familiar with a new drug and its safety profile during the early stages of its commercial use.

Our clinical trial registry provides information about all trials Roche conducts with patients and contains a database of key results from completed trials.

Patient Access Programmes

In the US there is no universal public healthcare system and treatment must be paid for. As healthcare is expensive, most people have health insurance to cover any treatment they need. Many companies provide health insurance for their employees, and there are government insurance programs for people on low incomes. But a significant number of people are still uninsured, either through choice, because their income is not quite low enough to qualify for a government scheme or because they do not know that insurance is available to them.

We run several Patient Assistance Programmes in the US that provide free medicines for people who need them but have inadequate or no health insurance. These include:

  • The Roche Patient Assistance Programme
  • The Partnership for Prescription Assistance
  • The Genentech Access to Care Foundation
  • The Genentech Endowment for Cystic Fibrosis

In a first-of-its-kind programme, Genentech has capped the overall cost of Avastin at US $55,000 per year for patients with incomes below a certain level, in any FDA-approved indication. The programme applies regardless of who is paying for the drug – the patient, private insurance or government-funded insurance. Genentech also contributes to independent charities that provide financial assistance for the medical treatment of eligible patients.