Iol news, Nobember 19, 2015. US and European pharmaceutical industries see South Africa as “ground zero” for keeping their large profit margins, say Julia Hill and Catherine Tomlinson.
Cape Town – Imagine that a diagnosis has turned your life upside down. Perhaps it is HIV and you must now take daily treatment for the rest of your life to remain healthy – but sometimes the pills are not available in the clinic because the single company supplying the medicine could not deliver enough. Or you could have a type of breast cancer, but need R500 000 to pay for a year of treatment that could save your life.
Perhaps the best medicine to manage your bipolar disorder is only available on the private market and costs nearly R29 000 per year.
You or someone close to you likely has a similar story. Many people living in South Africa struggle to manage outrageous medical bills, or forego medication when they cannot afford it. What you might find surprising is that the prices you pay for medicine can be exceptionally unreasonable when compared to other countries such as India, or even Japan and Canada.
You might be angry to know that policy, law and practice is in the process of changing in South Africa to address these problems – but the government is dragging its feet.
It should make you furious that the US and European pharmaceutical industries see South Africa as “ground zero” for keeping their large profit margins and are pressuring government to abandon reform, at the expense of people’s lives.
In South Africa, many important medicines are offered by only one big, multinational pharmaceutical company which holds a patent on the medicine. Patent holders have the exclusive right to market their medicine for 20 years, during which they can – and do – charge exorbitant prices, making the drug too expensive for government or medical schemes to afford.
One key reason companies are able to price gauge in South Africa is because they are often granted not one but many patents on the same medicine and prolong monopolies by years or decades.
This practice of “evergreening” is easy in South Africa, where patent applications are not examined to make sure they are deserved.
South Africa granted 2 442 pharmaceutical patents in 2008 alone, while Brazil – which examines patent applications – granted only 278 patents between 2003 and 2008.
Evergreening in South Africa blocks access to more affordable generics and biosimilars that are already available in other parts of the world. For example, patents in South Africa could block alternatives for breast cancer medicine trastuzumab, mental health medicine aripiprazole and arthritis medicine celecoxib until 2033, 2033 and 2020 respectively.
South Africa could save as much as R191 million a year on these three medicines if it could realise prices on par with India or Canada, where competition already exists.
In addition to driving up prices, monopolies can contribute to insecurity of supply. Patent protection on the antiretroviral (ARV) medicine lopinavir/ritonavir (LPV/r) is currently blocking use of quality-assured generic versions. Patent holder AbbVie has been unable to provide adequate supply of LPV/r to South Africa for more than six months, leading to widespread stock-outs and thousands of people being sent home without their treatment.
While AbbVie claims the problem is now resolved, more than 9 percent of 796 facilities in four provinces surveyed in October (Eastern Cape, Free State, Gauteng, North West) were still experiencing stock-outs of LPV/r and there is no guarantee that this problem will not arise again as more people go on ARV treatment.
People in South Africa have the constitutional right to have access to healthcare services. South Africa is also a member of the World Trade Organisation (WTO) and in 1994 signed on to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
TRIPS requires South Africa to grant patents on new medicines, but at the same time allows countries to develop national laws that ensure patent protection does not compromise people’s health. Since South Africa adopted TRIPS, patient advocates wanting to promote access to medicines have been in a tug-of-war with Big Pharma wanting to protect their profit margins.
South Africa has made various attempts to incorporate TRIPS safeguards into national law. Most notably, the Medicines Act was amended in 1997 to encourage use of available generic medicines and permit parallel importation – which allows the same manufacturer’s product to be imported from another country where it is sold at a cheaper price. This caused panic among international pharmaceutical companies, who under the Pharmaceutical Manufacturing Association (PMA) took Nelson Mandela’s government to court seeking revocation of the laws.
Patient activists mobilised and fought back worldwide, leading the PMA to drop the case.
Over the next decade, challenges filed against pharmaceutical companies at the Competition Commission by the Treatment Action Campaign and the Aids Law Project (now Section27) secured access to generic versions of many ARVs. Today, a first-line ARV regimen is 96 percent cheaper than the cost of a similar regimen in 2000, when only patented medicines were available in South Africa. Lower prices allowed for massive scale-up of life-saving ARVs through the public sector – reaching over 3 million people in 2015.
For six years, the Department of Trade and Industry (DTI) has been developing a national intellectual property (IP) policy which will inform changes to the Patents Act and other legislation.
The right changes would help limit the number of undeserved patents granted on medicines. They would also develop easier processes for government to permit generic supplies on the market when legitimately patented medicines are unaffordable or unavailable.
Unfortunately, the reform process appears to have stalled.
Despite past victories, many critical medicines to treat cancer, diabetes, epilepsy, mental health, hepatitis, drug-resistant tuberculosis and other diseases, as well as newer ARVs, remain under patent in South Africa and inaccessible to people that need them.
More comprehensive legislative reform is necessary. This is why 18 patient groups comprising the Fix the Patent Laws (FTPL) coalition** are advocating for full adoption of TRIPS safeguards into national law, in order to protect and promote access to medicines.
In 2013, the DTI promisingly released a Draft National Policy on Intellectual Property, committing to full adoption of TRIPS safeguards to protect health. The draft policy announced plans to introduce patent examination procedures and stric-ter criteria for granting patents.
It reiterated the government’s right to issue compulsory licences to allow generic suppliers on the market when patented medicines are not available. Yet for two years, the DTI has repeatedly broken promises to finalise the policy and introduce a bill to Parliament to amend the Patents Act. Pressure from Big Pharma to delay reform undoubtedly contributes to delays.
In 2014, the Innovative Pharmaceutical Association of SA (IPASA) – a rebranded PMA – hatched a plot to stall pro-public health reform by funding a R6 million covert lobbying operation. The plot, exposed in the media, was dubbed “Pharmagate” and referred to as tantamount to “genocide” by Health Minister Aaron Motsoaledi. Submissions to the DTI on the draft IP policy revealed that the American Chamber of Commerce (AmCham) and EU backed their industries’ calls to put profit before patients. A 2015 AmCham submission to the US Trade Representative suggested South African eligibility for ongoing inclusion in the African Growth and Opportunities Act be dependent on the country abandoning IP reform.
Last month, the FTPL coalition called on DTI Minister Rob Davies to clarify when to expect a finalised policy. In response, Davies noted that the DTI remained committed to pro-public health reform and the final policy would be adopted in early 2016.
Yet every day that passes, more patents are granted on pharmaceuticals in South Africa – perhaps on a medicine you will need in the future. At the same time, international companies holding patents are gaining at local producers’ expense and the trade deficit grows as we are forced to import expensive medicines from overseas. We can no longer accept delays that hurt our economy and jeopardise people’s lives.
As South Africa embarks on legislative reform, the international pharmaceutical industry will continue to use its deep pockets to try and undermine the process.
Ordinary South Africans whose lives are directly affected by the actions of this industry must make their voices heard. If you want to tell the DTI why reform can’t wait, send Davies a letter or a tweet (@the_dti) about what more affordable medicine would mean for you.
* Julia Hill is the Deputy Head of Mission for Doctors Without Borders, and Catherine Tomlinson is the Parliamentary Liaison for Doctors Without Borders.
** Fix the Patent Laws is a joint coalition of the Treatment Action Campaign, Doctors Without Borders; Section27; the Cancer Association of Southern Africa; the SA Depression and Anxiety Group; People Living With Cancer; DiabetesSA; Cape Mental Health; CanSurvive; the South African Federation of Mental Health; the Stop Stock Outs Project; the Schizophrenia and Bipolar Disorder Alliance; the South African Non-Communicable Diseases Alliance; Marie Stopes South Africa; Epilepsy South Africa; The Cancer Alliance; CHOC Childhood Cancer Foundation South Africa; and Advocates for Breast Cancer.
To find out more, visit http://www.fixthepatentlaws.org. They’re on Twitter: @FixPatentLaw.
*** The views expressed here are not necessarily those of Independent Media.
Image Credit: Paballo Thekiso