Once a clinical trial gets on track and patient recruitment has started, the main concern for drug firms is to supply the right drugs to the correct sites on time and within specification. Hundreds of sites, thousands of patients and years of testing add complexity and risks, especially when the trials are conducted in emerging markets such as China, India, Latin America, Africa or Eastern Europe.
Particularly, the increase in pharmaceutical cargo theft has hit some companies hard in recent years. Beyond the significant loss of money and trial delays, thefts also carry hidden consequences such as the incredible damage to a company's reputation and the need to recall products not yet released to market. Furthermore, stolen products can end up in the legitimate supply chain and pose a severe risk to patients.
Identifying security procedures that ensure a secure delivery of medical goods and maintain stock by minimising theft will be one of the topics on top of the agenda at Arena International's Clinical Trial Supply Europe.
Taking place on 21 and 22 February 2012 in London, UK, the event will bring together industry experts from around the world for the 13th consecutive year to discuss and uncover potential remedies to this issue.
Ahead of the event, we speak to Napp Pharmaceuticals process improvement manager within security operations Cathy Brown about the dangers and challenges of shipping medical cargo in emerging countries and about the strategies and technologies that can help to secure a safe supply chain.
Elisabeth Fischer: How big is the pharma industry's loss of medical stock through supply theft in emerging markets?
Cathy Brown: It is very difficult to put a figure on the loss of goods and stock through theft in emerging markets. There are so many different information sources and statistics collated by various different organisations so the picture is constantly changing.
In 2008 for instance, the number of pharmaceutical thefts in the US rose by a third, whereas in 2011 the number of thefts declined significantly.
According to data collected by Freight Watch International, the countries most vulnerable to cargo theft are Mexico, Brazil, South Africa, the US, Russia, India and the UK, but it's generally anywhere where there is high cargo theft. It is also important to note that as global theft risks vary from country to country, they also vary from region to region within a country.
However, the number of seizures for pharmaceuticals, mostly counterfeits, was 9% of the total seizures for theft of intellectual property in the US in 2011.
This is an increase over 2010 and the primary source country for these seizures is China. India and Pakistan also moved into the top ten source countries for seizures of counterfeit pharmaceuticals in 2011. So it is not only the theft risk that needs to be considered but also the risk of counterfeit supplies entering the supply chain.
EF: Why do emerging markets need greater security procedures when supplying goods for clinical trials?
CB: Emerging markets will always require amplified security procedures when supplying goods for clinical trials. The infrastructure in these countries is often not as well developed, journey times can be long and the trucks are often driving on open unpatrolled roads. Moreover, the local crime rates and the value of drugs on the black market can be quite high.
In addition, emerging markets often have no regulatory presence or complexity in the supply chain.
There can also be issues over traceability to the original source, issues over destruction as well as IP concerns, all of which can result in an increased risk of cargo theft.
EF: How can pharmaceutical companies identify the value of their drugs and medical supply on black markets in these countries?
CB: Information and intelligence from sources such as Freight Watch or Securing Pharma can be quite useful to help identify the risk of theft in specific regions.
Also, knowledge from the contract research organisation (CRO) and the investigator in the area, as well as the local logistics partner, should be sought. Sometimes it is even worth employing a specialist in the local country to provide the up to date information.
EF: What are the biggest challenges of ensuring the safety of medical supply during transport?
CB: The biggest challenges of ensuring the security of trial medical supplies during transport are how to get the supplies to the depot or investigator site safely and securely in a timely manner.
This comes down to knowing your supply chain and understanding the routing for the supplies so all aspects of security can be built into the process in advance.
The main risks during transportation are if the supplies are held up on route or left unattended at any time during transportation.
It is always important to know when the supplies are due to be delivered so that if they do not arrive on time an investigation can be instigated and escalated immediately.
Strategies to minimise product loss during transportation are to plan in advance of a shipment and ensure that knowledge of the product, the volumes to be shipped, the destination country and depot, the type of transport to be used and the actual route to be taken are understood in advance.
It is very important to understand all risks in advance so that contingency measures can be put in place to ensure a safe and secure supply.
EF: How much time and money should be spent on securing drug supplies to high-risk regions to ensure the safety of trial supplies?
CB: The amount of time and money spent will depend on the value of the shipment and the value of the trial to the company. A lost or delayed supply of a clinical trial can result in continuity of supplies and a pack not being available when the patient arrives for their supply.
As a result, extra taxes and costs will be high due to potential write-offs and then there is the time and cost of reproducing supplies, which can add lengthy delays to clinical trials and large cost implications to the business. I personally believe the cost of ensuring security is money well spent as this will reduce the risk of costly failures.
EF: What are the best technologies to put in place to track and trace drug supplies once they have been stolen?
CB: Various technologies can be put in place to track and trace the drug supplies during transportation. One of the most obvious solutions is to use GPS tracking on the vehicle transporting the supplies.
However, if the supplies get removed from the vehicle then tractability of the supplies becomes lost. So extra tracking devices such as real-time cargo trackers can be placed within the containers being shipped.
It is also important to ensure that the logistics provider has robust documented emergency procedures in place so that, in the event of a theft, the incident can be reported and escalated immediately.
In addition, the cooperation with local service providers and other pharmaceutical companies in the same region can help ensure secure trial supply.
Good relationships and prior auditing of sites and facilities can also be beneficial so that cooperation and understanding of the nature of the supplies and any special security measures is made clear at the start.
EF: Why do drug companies take the risk of outsourcing trials to emerging regions if there is a clear danger to the security of product supply?
CB: Companies cannot possibly have a presence in all countries of the world so it is inevitable that outsourcing occurs.
What is important is that companies work closely with local partners to prepare the way for the security of product supply. Shared knowledge and local audits are important to help understand any risks in the supply chain.
A visit or audit prior to supplies being made will provide an enhanced understanding of the local area and any potential transport difficulties compared to an 'audit questionnaire'. I'd say that even considering the dangers of medical supply theft, pharma companies will not stop to outsource clinical trials to emerging countries in the future.
The Arena International Clinical Trial Supply Europe will take place on 21 and 22 February 2012 in London, UK.