EU urged to confront 'global burden' of tuberculosis

A Parliament Magazine event on leveraging technology transfer to improve access to medicines was the forum for a discussion on innovative measures for tackling the rise in cases of multi-drug resistant tuberculosis (MDR-TB)

By Desmond Hinton-Beales

27 Jan 2015

The event, organised in cooperation with Eli Lilly, was hosted by British MEP Nirj Deva who began by underlining that "everyone has a basic right of access to clean water and medicine" as a starting point for discussing MDR-TB.
 
Drug resistant TB generally develops if patients fail to complete a full course of treatment for regular TB or if they take low quality medicines or do not receive first-line care. This is a particular issue for TB as it is often misdiagnosed and the treatment process is long with the drugs entailing many side effects.

For Deva, the "private sector has a key role to play in improving access to medicines", as well as contributing by "creating wealth as a means of ending poverty". "The top 500 multinational corporations account for 70 per cent of global trade. We must work with them if we are serious about tackling these issues," he added.

"Everyone has a basic right of access to clean water and medicine" - Nirj Deva


 A global burden
 
Executive secretary of the Stop TB Partnership Lucica Ditiu pointed to the scale of the problem by warning that "two billion people - one third of the world's population - are infected with TB". 

"Among that two billion, 10 per cent will develop it and out of the nine million new cases every year, three million fail to be diagnosed - this is a huge burden globally." Ditiu also highlighted the 1.5 million deaths that occurred in 2014 as a result of TB, stressing, "This is the same level as HIV."

"MDR-TB is a very unusual and horrible situation, involving a two-year treatment time and drugs that have a lot of side effects" - Lucica Ditiu

"One in three new cases already have MDR-TB," she said, adding that the "treatments for the disease are 50 years old". 
 
"MDR-TB is a very unusual and horrible situation, involving a two-year treatment time and drugs that have a lot of side effects. There is also a huge financial implication, with some hospitals in Sweden facing potential bankruptcy in the event of an outbreak."
 
Market forces
 
Walter Seidel, head of the health sector at the European commission's DG Devco, said that MDR-TB was an issue the EU takes seriously, reiterating that nine million new cases of TB occur every year, but added that only "70,000 people receive treatment" in Europe - a figure he said was "very low". 

"Access to medicines is a health system building block but you must address the whole chain if you want to be effective. Getting prices down is the most important objective" - Walter Seidel

Seidel said that part of the reason for such low levels of treatment was that the regime was "very demanding". He also said the rise in MDR cases was as a result of "multiple cause factors", including the "use of drugs for first-line treatment being used for other diseases, which is raising resistance". 

He also pointed to issues related to the cost of treatment, asking, "Why are drugs for MDR-TB so expensive?" "There is a very limited market for these types of treatment that is very highly regulated as those who work in the health sector don't want them to be easily available."
 
"Access to medicines is a health system building block but you must address the whole chain if you want to be effective. Getting prices down is the most important objective," he stressed. 
 
Political momentum
 
EPP deputy Eleni Theocharous also raised the issue of "millions of people around the globe" not having access to "effective and affordable medicine". For the Cypriot MEP, "the EU should support the production and facilitate the marketing of many excellent generic medicines".

"The EU should support the production and facilitate the marketing of many excellent generic medicines" - Eleni Theocharous

 
"The European parliament launched a written declaration on the threat of drug-resistant tuberculosis in the European region in 2013. Although it was not accepted, it was a great opportunity to raise awareness around the re-emergence of TB and MDR-TB. The political momentum created by the campaign will be used to advocate for stronger legislation on TB in the future."
 
Theocharous drew a parallel between Ebola and TB, calling them "neglected diseases", and saying that this was due to them being "prevalent in non-profitable markets". 
 
A unique perspective
 
Iain Richardson, senior director of manufacturing and transfer of technology leader at Eli Lilly and Company, agreed with Theocharous on the need to "strengthen ability of generic companies to produce medicines", adding that tackling the "regulatory burden" associated with manufacturing drugs for treating MDR-TB was a key issue. 
 
Richardson outlined the Lilly MDR-TB partnership, which was launched in 2003, as a case of steps being taken to "move drug production closer to the patient". With 60 per cent of MDR-TB cases occurring in China, India, Russia and South Africa.

"Lilly hopes to inspire others and highlight what we've learned" - Iain Richardson

Eli Lilly was producing two off patent antibiotics used for treating TB - capreomycin and cycloserine - for which the market was small. With this in mind, Lilly had planned to cease production before being made aware of medical findings which showed the two drugs' effectiveness in treating MDR-TB. 
 
With the "daunting levels of the drugs required" due to a dramatic increase in TB cases in the late 90s, Richardson said demand for the treatments was far outstripping the rate of production. Lilly took the decision to donate its trademarks and manufacturing knowledge and best practice to a set of carefully chosen partners, largely located in the areas most affected by TB.

This process - known as technology transfer - involves the passing on of skills and manufacturing knowledge so as to ensure wider access to an organisation's scientific and technological developments, allowing new users to exploit their experience and best practice. "Lilly hopes to inspire others and highlight what we've learned," said Richardson.

The MDR-TB partnership also provides training programmes for healthcare providers, aiming to improve the diagnosis rates for TB and ensure a proper continuum of care. 

"The affordability and availability of medicines is a huge issue" - Manjeev Singh Puri

One of Lilly's partners is Shasun pharmaceuticals, which is based in India - the country with the world's largest MDR-TB and TB burden. S. Abhaya Kumar, the CEO of Shasun, said that his company, which produces cycloserine, had experienced "upgraded recruitment and safety standards", as well as achieving a greater "environmental understanding" through its work with Lilly. 

India's ambassador to the EU Manjeev Singh Puri also spoke at the event, praising the results of the partnership, saying "collaboration is very important". "The affordability and availability of medicines is a huge issue. We need a population that can enjoy high health standards and a high quality of life."

"If we are to confront these issues we must identify partners, build capacity, then go forward, including on voluntary licensing from patent holders."

Kumar underlined the huge improvements in cost Shasun had been able to make in the production of cycloserine as part of the MDR-TB partnership. "The cost of a 250mg tablet is currently €0.10, it had been brought down from €0.32-€0.44 and from a few euros for Eli Lilly," he said.

"The cost of a 250mg [cycloserine] tablet is currently €0.10, it had been brought down from €0.32-€0.44 and from a few euros for Eli Lilly" - S. Abhaya Kumar

However, despite the success of the programme in transferring knowledge of the drugs' manufacture, Eli Lilly's MDR-TB partners have experienced regulatory barriers which are preventing the drugs reaching the market. 

Richardson said that the partners producing these drugs were required to tackle a "double regulatory burden" where the drugs require approval at local level as well as from a stringent regulatory authority for global sale. 

While there has been some success - Lilly's Russian partner is the first company in the country to meet the WHO's prequalification standards - the partnership was originally intended to finish in 2008-09 but is still running now due to barriers at the approval level. 

Richardson said there was a serious need for "political will to tackle these barriers". 

Deva closed the discussion by calling the Eli Lilly MDR-TB partnership "a great story", asking whether it was possible for the "world health organisation to issue a global certificate for these drugs". 

"We need a specific fund for tackling TB and we must look at the next steps for the millennium development goals. I want us to meet again in six months' time to see the progress we have made," he concluded. 

 

Want to know know more? Click here to learn about technology transfer and Eli Lilly's MDR-TB partnership.

 

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