12 April 2017

TB Drug
“We are happy to see this progress, but we do not
feel that it is enough” - Claire Waterhouse

Claire Waterhouse, Advocacy Officer for the MSF Access Campaign, talks about the struggle to get delamanid - a game-changing new medicine for drug-resistant TB - registered in South Africa.

Tuberculosis remains South Africa’s number one killer and the country faces one of the heaviest burdens of multidrug-resistant TB (MDR-TB) in the world since over 30,000 new cases occur each year. Agonisingly, fewer than 50% of people treated will reach cure and those who are able to endure the gruelling treatment suffer terrible side effects of medicines developed 50 years ago.

On World TB Day this year, the South African Department of Health announced the launch of a drug research programme that would see 400 patients get access to the promising new DR-TB drug delamanid over the next two years.

As good as this news is, it belies the massive needs of over 7,000 MDR-TB patients who could benefit from it but wait in limbo while delamanid is yet to be registered locally.

Claire Waterhouse, Advocacy Officer for Doctors Without Borders’ Access Campaign in Southern Africa, works towards removing the barriers preventing access to medicines through advocacy and policy. As an activist working to secure better TB treatments, she is at the forefront of the battle against this disease that kills more South Africans per year than HIV/Aids.

We caught up with Claire to get to grips with the fight to get delamanid registered.

What is delamanid and why isn't it widely available in South Africa?

Delamanid is a new drug developed for treating drug-resistant TB (DR-TB). It is showing huge promise due to its less toxic side effects and potential for shorter treatment courses. It opens the door for much better quality of life for TB patients.

Delamanid is unfortunately not yet approved in South Africa by the Medicine Control Council. Even though clinical trials were conducted in South Africa for this drug by the Japanese pharmaceutical company Otsuka, it has not yet registered it locally. This is unacceptable.

We are pushing Otsuka to register it immediately, so that it is widely accessible and priced affordably for all DR-TB patients who need it.

What is MSF fighting for?

Until it is registered, it is impossible to have widespread access for the estimated 7,000 people who need the drug. MSF doctors currently treat the biggest group of DR-TB with delamanid – around 70 patients – and we see phenomenal results. We are very hopeful about what could happen if we had proper access to delamanid in South Africa. All DR-TB patients in South Africa stand a chance at a much better quality of life and treatment through delamanid.

In the meantime, Otsuka has only negotiated a clinical access programme with the South African Department of Health to provide 400 treatment courses – enough to treat patients for only 1 year.

We are happy to see this progress but we do not feel it is enough. We want Otsuka to commit to providing more courses so that access can be expanded before registration happens. Imagine what would happen if those 400 courses ran out before the drug was fully registered in South Africa – it would be unethical and unacceptable to have to stop treating people who need this drug simply because Otsuka continues to delay its registration.

What are the barriers?     

The barriers to getting delamanid accessed widely, are multiple:                                        

First: There is the issue of registration which generally takes at least a year. So, there is real urgency required here.

Secondly: The pricing of the drug. At $1700 (R23 590.19), equivalent to $283 (R3 927.07) per month per person that is not affordable, which is simply not reasonable for a country like South Africa with such a high burden of TB. We know that Otsuka can afford to charge significantly less than this. There was a study conducted which said the estimated cost of delamanid is $3.50 - $8.16 (R48.57 – R113.23), which is a ridiculous difference when compared to the cost per patient.

Thirdly: Patent laws. Delamanid is patented significantly in South Africa, with secondary patents protecting the monopoly of Otsuka until at least 2032. This means that no other competitors will be able to enter the South African market until then, allowing Otsuka to maintain whatever price it wishes. The earlier entry of generic competition would significantly help to reduce pricesThis systemic barrier is very difficult to overcome and requires South Africa to reform its patent laws to ensure they prioritise people over profits (you can read more about our work on patent law reform here).

What about the progress so far, isn’t it a victory? And what has to happen next?

Until delamanid is fully registered in South Africa and being provided at an affordable price, we will not see will not see a victory for patients in need. We applaud the Department of Health for negotiating an interim deal with Otsuka, but this is far from enough.

In the most immediate term, we need Otsuka to publicly say they won’t allow patients to go untreated if their 400 donated courses run out before they register the drug.

Who are you working with?

Doctors Without Borders South Africa is working closely with the South African government, civil society groups, TB clinicians and TB patients on these issues.

How can others get involved?

We welcome anyone interested in being involved! People can either go directly to Otsuka to demand that they register delamanid in South Africa, or they can contact the MSF Access Campaign.

Claire Waterhouse - Access Campaign Advocacy Officer

Cell: +27 (0) 79 986 8680 | Tel +27 (0) 11 403 4440/1/2

[email protected]

For more on the fight to register delaminid and secure better TB treatment in South Africa:
Read Claire’s blog post on Huffington Post here.