THE BLOG

SA's Drug Patent Laws Must Be Changed Now. People Are Dying.

When drug companies can charge whatever they like for life-saving medication, people die.

18/01/2017 04:57 SAST
Schalk van Zuydam/AP

Late last year, one of South Africa's bravest women passed away. You may not have known her name, but she was fighting for one of the country's most important causes. Her legacy will live long after her death due to the thousands of women who will, eventually, benefit from her courage, determination and the example she set for us all

But she need not have died.

Tobeka Daki was a mother of two sons from East London, on the southeast coast of South Africa. She was diagnosed with HER2 positive breast cancer in 2013, and was a good candidate for a drug, trastuzumab (marketed by Roche as Herceptin), which is recommended by the World Health Organisation as an essential treatment for this type of cancer. Trastuzumab can improve overall survival rates of affected women by up to 37%. Despite this, and being a member of a medical scheme, Tobeka was never able to access this treatment due to its extraordinarily high cost and lack of access in the public sector. Eventually, the cancer spread to Tobeka's spine, and she lost her battle on 14 November, 2016.

So why is this drug priced out of reach for South African women? Why couldn't Tobeka and many women like her access a drug that may have helped to save their lives?

The answer lies in South Africa's current intellectual property laws. Currently, if a company (like Roche) wants to patent their drug in South Africa, all they have to do is fill in a form and pay the fee. If this is done correctly, a corporation will receive monopoly protection of their product for the next 20 years. During these 20 years, no generic versions for that product can be produced in or imported into South Africa.

This means that drug corporations can charge whatever price they want – even for life-saving medicines like trastuzumab that are so desperately needed in South Africa. What does 'whatever price they want' mean? Well, in the case of trastuzumab, the price for a 12-month treatment course through the private sector is approximately R485,800[1] (approximately US $35,300, or, roughly, 3 times more than the average annual salary of a high school teacher in South Africa).

To improve the situation for the future, South Africa must reform its patent laws. The government must develop strict patentability criteria so that only those medicines that truly deserve a patent are awarded one.

The example of trastuzumab is not exceptional though. There are many medicines that people living in South Africa desperately need but can't access because of exorbitant prices, including for cancer, hepatitis, mental illness, HIV and TB[2].

But there is a solution. To improve the situation for the future, South Africa must reform its patent laws. The government must develop strict patentability criteria so that only those medicines that truly deserve a patent are awarded one. The government must ensure that each application is examined by a trained patent examiner to ensure that the criteria are properly met, and that there are clear procedures to oppose the granting of patents that are invalid. It must improve a legal right known as "compulsory licensing", which allows governments to override patent monopolies to bring generics onto the market when prices are too high, as a means to save lives. And finally, the South African government must ensure that there are policies and measures in place to tackle high prices, and fix regulatory and supply blockages, to ensure access to vital medicines.

The Fix the Patent Laws campaign, a coalition of 31 patient groups including Médecins Sans Frontières/Doctors Without Borders (MSF), is lobbying the Department of Trade and Industry (the DTI) to reform its intellectual property policy in exactly these ways. The current process of reforming South Africa's patent laws has been glacially slow, having been started by the DTI in 2009 and with the final reform being delayed multiple times. People like Tobeka are literally dying as a result of these laws and the slow pace of change, and it's time for the government to implement intellectual property policies that prioritise people's health and their ability to afford and access lifesaving medicines.

The DTI has promised a new intellectual property policy by March 2017. The direction this policy takes is crucial to the future of how we access medicines in South Africa.

This is a true opportunity for South Africa to set a strong global example. We can be the country that finally takes a stand and protects the health of its inhabitants over the profits of the pharmaceutical industry. We can be the country that says enough is enough. We can be the country that shows that Tobeka did not die in vain.


[1]http://www.fixthepatentlaws.org/wp-content/uploads/2016/09/MSF-FTPL-report-FINAL-VERSION.pdf at page 19

[2] See the Fix the Patent Laws latest report with 9 examples of medicines being blocked by our outdated patent laws here: http://www.fixthepatentlaws.org/wp-content/uploads/2016/09/MSF-FTPL-report-FINAL-VERSION.pdf