Source: The Guardian
20 Mar 2015
New drugs for hepatitis C are a major breakthrough but hugely expensive in rich countries. Pharma giant Gilead will allow cheap copies to be made for poor countries – but only for patients with proof of identification and citizenship and the drug supplies will be closely tracked
The battle over access to the new hepatitis C drug, Gilead’s sofosbuvir (and similar drugs coming along behind) is hotting up. There is angst even in the richest countries over the $1000 a pill price tag. It now looks as though Gilead is going to extraordinary lengths to ensure that cheaper versions, which it is permitting generic companies to make for poor countries, do not arrive in affluent world pharmacies.
Gilead has agreed to grant voluntary licences to eleven Indian generic companies, which means the drug will be sold at a reduced price in low-income countries. But Médecins Sans Frontières, the volunteer doctors who are treating hepatitis C infection in some of the poorest regions, say the company has imposed unacceptable conditions.
Gilead stipulates that patients will only get the drug if they can provide identification, proof of citizenship and residency, which MSF says will penalise refugees and marginalised communities. The drug supplies will be closely tracked through codes on the bottles. Gilead, even though it will not be the manufacturer, will have access to that information. If they need more, patients will have to return an empty bottle.
Gilead told the Business and Human Rights Resource Centre, which asked for a response on behalf of MSF, that it was:
designing measures to ensure that these high value curative medicines are not diverted from their intended recipients – patients in need. The measures implemented will be the result of a consultative process and needs assessment involving multiple stakeholders, and continue to evolve to address the needs of all concerned in delivering care.
But MSF says that the anti-diversion programme:
is unprecedented with respect to the invasiveness and impact it will have on medical providers and patients. To our knowledge, no company, including Gilead, has ever put in place such a programme in the past.
We disagree that diversion of medicines is a valid concern – such claims harken back to the rhetoric of the multinational pharmaceutical industry over a decade ago with its stance towards the production and use of low-cost anti-retroviral medicines in developing countries to treat HIV and AIDS, in the face of a large-scale epidemic. Even if diversion was a valid concern, imposing heavy, unethical burdens on patients and doctors is not acceptable and not a solution.
Anand Grover – former United Nations Special Rapporteur on the right to health – has also weighed in against the company on this issue:
Gilead’s anti-diversion measures contradict their stand on improving access to crucial HCV [hepatitis C] medicines, and is, arguably, a violation of the right to health. The responsibilities of pharmaceutical companies in relation to ensuring access to essential medicines as a part of the human right to health under international law are well-established. Gilead’s responsibility to respect the right to health requires it to refrain from adopting policies that negatively impact access to medicines such as the proposed anti-diversion measures.
MSF’s access campaign has other complaints. There are no licences for generic companies in middle-income countries, such as China, Thailand, Ukraine, Iran, the Philippines, Argentina and Brazil. And the licence given to Indian companies bars them from selling to those countries. There are 49 million people living with hep C in those excluded middle-income countries, of which 30 million are in China. Yet even the high-income countries are struggling to afford sofosbuvir for the large numbers of people with the virus. In the UK, the NHS has postponed the introduction of the drugs for all who will need them for six months.
The generic companies can bring the price of a cure – because that’s what these drugs offer – right down. Two Indian generic companies have pitched prices so far at just under $1000 for a 12 week course of treatment, which is around $12 a day. But it could be still cheaper. Dr Andrew Hill at the University of Liverpool has shown sofosbuvir costs as little to make as $100 for 12 weeks’ treatment, which is around $1 a day. Diagnosis and treatment together could cost as little as $170, he calculates.
Rohit Malpani, Director of Policy and Analysis at MSF’s Access Campaign, said:
Now is the time to make sure as many people as possible can be treated and cured of hepatitis C, not to look for ways to restrict people’s access to treatment and overburden drug dispensers with rules that are unnecessary. Gilead’s actions are unacceptable.