In March 2013, as conflict raged in Syria, it took the UN agency responsible for the well-being of Palestinian refugees nearly six months to bring medicines to refugee camps in Damascus, as many were stuck in Beirut, Lebanon’s capital, 85 kilometres away. “The challenge of transporting medicines into Syria was truly a nightmare at the beginning of the conflict,” says Akihiro Seita, health director of the United Nations Relief and Works Agency for Palestine Refugees (UNRWA).
The agency, which provides humanitarian services to more than five million Palestinian refugees displaced by the Arab-Israeli conflict of 1948, sent medicines by air and sea to Beirut, and then by road to Damascus. Sometimes medicines were held in port until the Lebanese government granted an import licence — all the while incurring costs. “Delays cost us a lot of money… and eventually it took us an extra couple of months, which is too long for us, to get the medicines to refugees in Damascus,” says Seita.
The main challenge for UNRWA in Syria is the safe delivery of medicines from outside Syria to its 14 functional health centres serving 560,000 registered Palestinian refugees —half of whom have been internally displaced since the conflict began, with a further 12% fleeing to neighbouring countries. UNRWA also uses 12 of its shelters as mini health points to make sure people have access to primary healthcare. “We almost ran out of medicines in Damascus because many medicines were stuck in Beirut,” says Seita.
The medical treatment of refugees in the 21st century is dominated by non-communicable diseases (NCDs), says Seita, such as diabetes and hypertension rather than communicable or infectious diseases. “NCDs have a high prevalence in these populations, with or without conflict, and we must not forget that,” he says. For instance, NCDs make up around 70% of deaths among Palestinian refugees.
Humanitarian bodies are seeing increased red tape around the supply of medicines in countries hosting refugees. These bodies prefer to source medicines centrally in cost-effective terms on the international markets. However, the bureaucracy around importing their medicines, as well as complying with local country requirements, is adding to the complexity of providing much needed medicines to refugees in and around conflict zones, restricting humanitarian organisations to purchasing medicines on local markets. The quality of the locally bought medicines, however, cannot always be assured, and there can be limited supplies and drug shortages.
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There are many regulatory constraints associated with importing medicines into countries hosting refugees and in some countries, particularly in the Middle East, importing medicines is almost impossible.
MÃ©decins Sans FrontiÃ¨res (MSF) is unable to import its drugs into Jordan and must therefore source them from within the country. “We buy locally because it is impossible to get the import licences for our medicines quickly and at reasonable cost from the Jordanian authorities,” says Miguel Serrano, section pharmacist for the Dutch division of MSF.
MSF procures 80% of its medicines centrally for its global programmes and 20% locally. If it has to buy locally it only does so after it has obtained a positive risk-assessment of their quality.
Source: Dina Debbas
“That volume of local purchases is getting larger over time. A lot of the countries where we cannot import are located in the Middle East. Many of our operations in the region grew following the Arab Spring,” says Serrano.
Of the 3.7 million registered Syrian refugees, the majority are in Lebanon, followed by Turkey, Jordan, Iraq and Egypt, according to the UN Refugee Agency (UNHCR).
The International Committee of the Red Cross (ICRC), which each year ships 1,400 megatonnes of drugs around the world from its warehouses in Geneva, also buys drugs locally in Jordan. This happens in exceptional situations when the recipient country will not allow it to import, or when ad hoc purchases are needed because there are medicines shortages, explains StÃ©phanie Arsac-Janvier, head pharmacist at the ICRC.
Buying locally, however, can be problematic if supplies are insecure. “We see medicine shortage problems around once to twice a month and that means we have to find therapeutic alternatives which can be risky, for quality reasons, until the distributor has replenished their stock,” says Serrano.
In the past six months, MSF has experienced repeated shortages of local anaesthetics, such as lidocaine, as well as of haloperidol, antibiotics (amoxicillin syrups for children), and povidone iodine antiseptics, according to Serrano. Haloperidol is used for some refugees who may be in an agitated mental state after departing their homes in Syria.
“We saw months of shortages. We see this when a distributor has a monopoly on a product and frequently runs out of stock, because the distributor is serving other clients. This is a major constraint,” says Serrano.
When this happens, therapeutic alternatives are sourced, but this is not always feasible since the alternative may not be on the care protocols used by MSF doctors. When haloperidol was unavailable, risperidone was sourced as an alternative drug after MSF’s pharmacists conducted an assessment of other distributors in the field.
Drugs bought locally can usually only be bought in small batches, and are more expensive than buying on international markets. “In Lebanon, when we bought medicines locally, it was often 5–10 times higher than the international prices,” says Seita.
One advantage of local procurement is that it offers faster delivery to patients. But it is difficult to ensure quality. George McGuire, chief medical logistician of the ICRC, says that if there was an absolute guarantee that there were no counterfeits, then local purchase would be the obvious, efficient way to supply to all its health programmes.
Each country has its own regulatory framework for medicines and expects humanitarian bodies to buy medicines that are registered in that country.
For ICRC, supplying its medicines during a crisis in 2003 was relatively simpler than it is now. “We are having to customise supplies to individual countries as they have their own drug regulations. The amount of documentation needed varies country by country for the importation of medicines. This is a big challenge for us,” says Arsac-Janvier.
McGuire explains that it is a country’s privilege to have regulations. “In some cases, if you have a real emergency, you could expect more flexibility but… humanitarian organisations are guests of the country so we should also be humble and not demand that we can just roll in with our trucks,” he says.
The level of sophistication differs from country to country, too: some want to see a certificate of pharmaceutical product, or a certificate of analysis. Others may want at least 75% of the shelf-life remaining, and some want a patient information leaflet in the box.
“In ten years’ time, we probably will be obliged to buy medicines locally during a crisis as it becomes impossible to import,” says Arsac-Janvier.
If an agency were to customise for each country, it would have to stock up to five different brands of a medicine to satisfy the different requirements. This could lead to delivery delays, she adds.
The ICRC secures the quality of its medicines by procuring a lot of them in Europe. For local purchases, it relies on the results of Good Manufacturing Practice (GMP) audits of manufacturers by the World Health Organization’s prequalification scheme (which deals with malaria, tuberculosis and HIV drugs) as well as by other humanitarian bodies, such as MSF and UNICEF.
UNHCR uses wholesalers, with whom it has agreements to acquire medicines for its programmes. To ensure the medicines meet the international standards of quality, there are two criteria: they need to be on the UNHCR standard essential medicines list (EML), which is a slighter shorter version of the WHO’s EML; and they need to have a certificate of GMP from the manufacturer.
Another challenge facing humanitarian groups is dealing with trade embargoes, where a pharmaceutical manufacturer does not want to supply medicines for use in certain countries in contravention of a particular embargo.
Although humanitarian trade — which involves the supply of food, medicines and medical supplies — is exempt from US trade embargoes, independent reports support allegations that access to medicines is affected, argues Beverley Snell, associate principal fellow at Australia’s Macfarlane Burnet Institute for Medical Research & Public Health, who has worked with Health Action International (Asia Pacific) on access to essential medicines.
The ICRC saw the potential effect of US trade embargoes in Libya in 2011. “Luckily for us, we had enough stock in our Geneva warehouse to supply medicines to people in need and did not have to rely on US pharmaceutical manufacturers. But potentially it could have been a problem,” say Arsac-Janvier.
Global validation scheme
A global system that assured the quality of medicines would help humanitarian organisations supply medicines. For example, WHO’s prequalification list — which at present assures the quality of a small number of drugs — could be applied to all essential drugs. “[That] would be a dream come true,” says McGuire.
“Today there is information sharing between agencies but if you want to ensure the quality of products, you have to hire a consultant to inspect a manufacturing site, which is extremely time consuming and expensive,” he explains.
McGuire says a global prequalification system would allow the sharing of resources and access to reliable data, which would help to address problems around counterfeit and substandard drugs.
“Such systems exists for HIV, TB and malaria drugs and some others,” says Seita “but for the vast majority of essential medicines, including NCD drugs, such systems don’t exist.”
But some organisations are already getting prepared for the increasingly complex nature of drug procurement in conflicts and emergencies. Over the past couple of years, the ICRC has stationed regional pharmacists in key areas around the world — Kenya, Jordan, Pakistan, Ivory Coast — to help it understand drug regulatory systems so it can better customise the procurement of medicines locally. “These pharmacists will be trained and prepared for when a crisis occurs. We want to be proactive on solutions,” says Arsac-Janvier.
Others would also like to see some flexibility on importation procedures. “There are some countries where it can take several months to import even emergency supplies,” says McGuire, although he doesn’t want to identify the countries that have caused delays. He explains that there are international conventions to ease emergency response but not everyone has signed up to them. “There are four international conventions, as well as one recommendation, which include provisions for the facilitation of the importation of relief goods, including medical supplies, during crises. However, their provisions are legally binding only for states that have ratified them, which at present represents between 26% and 49% of countries worldwide.”
The Jordanian authorities helped MSF to find local products, but were not so helpful in giving exceptions to import medicines. “They basically want MSF and other humanitarian actors to use locally marketed medicines,” says Serrano, adding that it is a profitable market for local pharmaceutical companies “if you are buying their products to mitigate ongoing emergencies”. Part of the justification for this local procurement could be the immense national costs of looking after large refugee communities in these countries, suggests Seita.
Two years on, the UNRWA has developed better ways of getting medicines into Syria. It transits medicines through the Beirut airport, which means there is no need for import or export permissions from the government, before flying them on to Damascus. It also uses the sea port in Lattakia, Syria, which is government controlled, and transports medicines to Damascus by road from there.
However, trucking medicines on from Damascus to its health points across Syria is still a major challenge, especially in conflict zones. “It is an ongoing struggle to get medicines to these sites,” says Seita.
Although all of these struggles make a difficult job worse for NGOs, Seita argues that it is important there are strong regulatory systems in place. “If countries allow us to import anything that is not good for their national health systems. It is good that these countries have a strong regulatory system and their rules are respected, otherwise how would they develop?”