Nigerians were without MDT supplies for a year. How do we prevent that from happening again in countries worldwide?

Perspectives from Nigeria, ILEP, Novartis, and GPZL

Nigerians were without MDT supplies for a year. How do we prevent that from happening again in countries worldwide?

Nigerians were without Multi Drug Therapy supplies for a year in a delay that has needlessly placed patients at risk of developing impairments and allowed the disease to continue to be transmitted.

As Reuters reports, ‘Nigeria ran out of stock of multi-drug therapy in early 2024 as a bureaucratic delay in supplies and new domestic testing regulations on imported medicines held up the drugs in India, where one of the components is made.’

In this article we talk to key players in the field of MDT Supply Chains to find out how we can secure MDT supply chains in the future, so no one is left without access to treatment.

What went wrong in Nigeria?

Nigeria's regulator for food and drugs - NAFDAC - has recently been elevated to a level three regulator by WHO and as a part of that elevation, they have had to put in place certain processes and regulations. One of these regulations is a quality test on drugs coming from China and India. This has been the case for two years, but this is the first time the country has ordered new MDT supplies since then.

The labs that are responsible for undertaking these tests are in India and China, so there should be no problem in getting the medication to them. This is where I start to feel uncomfortable about what happened. The blame is being placed on the Nigerian leprosy programme because they placed their order late. It's true that this happened, but that doesn't explain such a year-long delay. There were lots of parties involved in the process, but in emails that went back and forth over three or four months, they were all pointing the finger of blame elsewhere. It's very unclear to us why this delay happened, but while the different parties were blaming each other, Nigerians weren't receiving the medication they needed. In the end, the government agreed to a waiver for this medication so that it doesn't need to be tested on this occasion. It will in the future.

Dr Sunday Udo, Country Lead, TLM Nigeria

A broken system

There seem to be two major flaws in our system.

The first is that countries need to order their MDT supplies on time. If Nigeria had ordered their supplies with plenty of advanced notice, then all of the additional time requirements because of the NAFDAC regulations would not have caused a crisis. We would have had enough slack in the system to allow for testing to be sorted out before the in-country MDT supplies ran out.

The second problem is that, if a country has not placed an order, no one seems to know. There is no system in place to highlight when a leprosy endemic country has failed to make an order. There is no surveillance system in place to pick up when something goes wrong.

Togo is a good example of this. The first time we were aware there was any problem was when the GLRA lead in Togo said that there was no MDT available. We contacted WHO and they reported that Togo had not requested new medication. When we produced the order form from several months prior, they realised that the order had been placed, but it had slipped through the net. The system we have is quite complex and the more complex something is, the more likely it is something will fall through the cracks.

Geoff Warne, CEO of ILEP

What lessons have we learnt for Nigeria?

Yes, the initial challenge around early forecasting and timely requisition can and has been addressed. The request for 2025 was made long ago because this problem has been recognised. There were some changes within the government's leprosy programmes that made this situation worse, but that is behind us now and we can forecast our MDT needs better.

But the real problem was caused by the quality check on the drugs. Until we get to the bottom of what happened with that, we cannot clean up the process. NAFDAC will not remove these requirements and so we need to learn for next time.

Yes, we can engage with NAFDAC better, but that includes communicating the NAFDAC requirements clearly to all parties involved. We can't afford to wait for other parties to fight it out again.

Dr Sunday Udo

How can the global leprosy community respond?

If Nigeria and Togo are struggling, then this could occur in other countries, as well. At GPZL, we have created a working group to look at this issue, which involves players from across WHO, Novartis (the drug supplier), ILEP partners, and national leprosy control programmes.

We have selected eight countries to review, each of which presents different challenges in terms of size, rural populations, and differing levels of endemicity. We are hiring a drug supply chain contractor who will work with us to establish the problems in the MDT supply chain. This will include interviews with relevant parties across those eight countries.

We're hoping to conclude this research by the end of 2025 so that in the first quarter of 2026, we can write up recommendations for parties at different levels of the supply chain process. We'll have country-specific action plans, as well as actions for WHO and pharmacuetical companies.

Dr Ritu Ghosh, Executive Director of the Global Partnership for Zero Leprosy (GPZL)

The role of ILEP partners

MDT is a combination of drugs that is only used to treat leprosy, so it's not included within a country's essential drugs list, which has its own process and momentum. That means the responsibility for ordering these drugs is solely resting with government leprosy control teams.

However, there is currently a disconnect between the government ordering systems and ILEP partners. Most ILEP partners are not involved in this process at all, which is regrettable because we are so engaged in many other areas of the national leprosy control programmes.

The process for ordering MDT is a little complicated at points and government staff could benefit from the support of ILEP partners in that process. Especially when you consider that staff turnover in government health departments is quite high, whereas the turnover in ILEP partners is much lower. The institutional memory in ILEP partners is a valuable asset in this situation. These ILEP partners could play a role in securing the supply chains and ensuring orders are placed correctly and on time.

Geoff Warne

The future of MDT supplies

Imagine if there was no solution this time. Imagine if we had no waiver in place and the drugs were still not arriving. Only one manufacturer in the world provides Rifampicin. If there is a problem with them, we would have to keep waiting and waiting. That's not fair. Could there have been another option?

The whole world is relying on one source and if the source has an issue, the whole world is struggling. Is it a question of having reserves of the stock to cover us if this happens? Or do we have to look elsewhere?

Dr Sunday Udo

The role of OPLs

Organisations of Persons Affected by Leprosy (OPLs) are really mobilising and bringing attention to this issue. That's important because a lot of people are refusing to come forward for treatment because they fear the stigma and they don't understand the value of treatment. When we talk about supply chains, we have to understand that demand is just as important as supply. If people are too afraid to come forward for treatment, we do not have a clear picture of demand.

The role OPLs are playing in raising awareness of MDT supplies with governments and authorities is vital, as is their work to eliminate stigma and encourage people to come forward for treatment.

Dr Ritu Ghosh

We could face big problems in the future. Another global pandemic, climate and conflict, impurities in Rifampicin. All of this could harm the supply chains. Equally, we would have a big problem if Novartis ever decided to no longer provide MDT free of charge. These agreements are signed every five years, so we would likely have enough time to respond, but that's not a guarantee.

That is why OPLs are essential. They hold governments and those in power accountable and ensure they are fired up by the needs of persons affected by leprosy. They make everyone aware of the human face of this very technical problem.

Geoff Warne

Five takeaways:

Countries must order on time: The process for MDT supplies is complicated when countries do not order their supplies on time and in the correct quantities.
Improving MDT processes in WHO: Orders are going missing and there is no monitoring of when orders have not been placed.
ILEP Partners could offer more support: If a country's leprosy team is struggling with the MDT ordering process, ILEP partners could support that process using their expertise.
OPLs have an invaluable role to play: When bureaucracy slows down the supply of MDT, OPLs have an important role to play in reminding authorities why the process must be sped up.
This is a human rights issue: When delays like this happen, there are people who are left without access to vital medication. This cannot be allowed to happen again.

“We are proud to have donated more than 8.2 million leprosy treatments to the WHO since 1999, which have helped to reduce the number of cases around the world by 95 per cent. We remain committed to work towards the eradication of this disease.”

A statement from Novartis

To prevent these recurring crises, it is crucial to improve forecasting, stock management, and distribution logistics while ensuring consistent funding and regulatory efficiency. However, the most urgent issue to address is government negligence, which exacerbates the already critical conditions faced by persons affected by leprosy due to inequality and exclusion. The violation of their rights must be denounced, and concrete measures must be taken. This also implies substantial reforms in health systems.

A comment from Beatriz Miranda-Galarza, UN Special Rapporteur on leprosy