Operation Storm Final Report 1. Introduction Operation Storm is a multi-country operation combating counterfeit pharmaceuticals. This operation brought together Customs, Drug Regulatory Agencies and the Police of each participating country. In the run up to the operation, INTERPOL, together with the World Health Organization (WHO) and the World Customs Organization (WCO), coordinated planning meetings and organized training session. The overt phase of the operation took place between 15 April and 15 September 2008. 2. Aim of this Report The aim of this report is to summarize the work done in the lead up to, and during, Operation Storm. This report will discuss the operational outcomes and findings, as well as provide recommendations for the way forward. 3. Background The intention of Operation Storm is to exploit the intelligence dividend arising from Operation Jupiter - South East Asia and to develop a systematic partnership approach to combat transnational organized criminal counterfeiting of medical products in the Greater Mekong Sub-Region. To this end, the objective of Operation Storm is to conduct simultaneous operations among participating countries. Operation Storm is coordinated by INTERPOL under the framework of the WHO s International Medical Products Anti Counterfeiting Task Force (IMPACT) Initiative. This initiative is also supported by WCO. Representatives from Customs, Drug Regulatory Agencies and the Police in affected countries such as Cambodia, China, Indonesia, Laos DRP, Myanmar, Thailand and Vietnam participated in the operation. In the course of preparing for the meeting, it was also decided that the operation would undertake to carry out pharmaceutical market surveillance in order to bolster field intelligence that can aid future operations.
4. Methodology of Operation Storm Planning Meetings INTERPOL organized three planning meetings in the lead up to the overt phase of Operation Storm. A final meeting will be held after the close of the operation to debrief and evaluate operations to measure their effectiveness and report results. 1 st Planning Meeting in Jakarta, Indonesia The first planning meeting was held in Jakarta, Indonesia, on 16 November 2007. During this meeting, agreements were reached with representatives from the three national agencies - Customs, Drug Regulatory Agencies and the Police - to commit to the Operation Storm working plan. The representatives agreed to return to their parent organizations to seek the necessary authority from their respective hierarchies to provide INTERPOL with intelligence for analysis and to be acquiescent to the participation of the private sector in the operation in order to supplement intelligence and to assist in developing cases. 2 nd Planning Meeting in Bangkok, Thailand The second planning meeting was held in Bangkok, from 11 to 12 March 2008. During this meeting, representatives agreed on the modalities and lines of communication. Four classes of medicines were identified as priority because they were readily counterfeited in the participating countries and posed significant public health risks. These were as follows: Anti-Malaria medication; Anti-Tuberculosis medication; Anti-HIV drugs; Antibiotics, specifically those for pneumonia and child-related illnesses The Health Science Authority (HSA) Criminalistic Laboratory in Singapore offered their forensics analysis services to participating countries. A protocol was established so that countries would be able to submit samples for testing through the INTERPOL Liaison Office in Bangkok (LOBANG). INTERPOL, WHO and WCO also wrote to the various heads of agencies to request support for Operation Storm and to encourage the national agencies to share intelligence among themselves and with their foreign partners. Assessment Meeting in Hanoi, Vietnam An assessment meeting was held in Hanoi, Vietnam, midway through the operation, from 1 to 2 Jul 2008, to ensure that the operation was on track and to 2
resolve any issues. Country representatives reported on their progress. The meeting provided them with a platform to share intelligence and best practices. Final Meeting in Phnom Penh, Cambodia The final meeting for Operation Storm was held in Phnom Penh, Cambodia on 17 November 2008. The final report was presented and future plans for the operation were discussed during this meeting. Training Sessions INTERPOL organized the IMPACT Enforcement Training sessions that ran consecutively to the planning meetings. These training sessions catered for officials from Customs, Drug Regulatory Agencies and the Police who have basic or no experience dealing with crime involving counterfeit pharmaceuticals. Trainees also received the localized versions of the Permanent Forum on International Pharmaceutical Crime (PFIPC) manual. Trainers were recruited from the standards board agency, United States Pharmacopeia (USP), regulatory agencies, the Therapeutic Goods Administration (TGA) of Australia, WCO and private pharmaceutical companies Eli Lilly and Sanofi-Aventis. The training sessions were held in Bangkok on 13 and 14 March 2008; in Hanoi on 3 and 4 July 2008; and in Phnom Penh on 18 and 19 November 2008. Up to 30 personnel from the three national agencies attended each session. These sessions typically ran for two days, and included scenario trainings, counterfeit identification and sample-handling techniques. Lines of Communication An Operation Storm Coordination Team (OSCT) was formed, comprising of representatives from INTERPOL, WCO, and the WHO Western Pacific Regional Office (WPRO). Representatives from three national agencies, together with the Operation Storm Coordination Team, established protocols for lines of communication. The national agencies were encouraged to share intelligence among themselves. During their communication with the OSCT, they would keep their national NCB in copy. The national agencies can also choose to communicate with the OSCT through their national NCB. Additionally, the OSCT and the national agencies may also exchange intelligence with the private sector, should they choose to do so. The lines of communication are summarized in the figure below: 3
Operation Storm Exchange of Information Process DRA Police Customs Private Sector Operation Storm Coordination copy Team in copy INTERPOL National Central Bureau LEAs communicate among themselves LEAs communicate with OSCT directly, keeping NCB in copy LEAs communicate, through NCB, with OSCT LEAs and OSCT communicate with the private sector directly Private Sector Input Operation Storm included the inputs of the private sector. These were mainly private pharmaceutical companies which were willing to supplement intelligence and to assist in developing cases. They handed over case files for seven cases, through INTERPOL, to representatives of the respective national agencies during the 2 nd planning meeting in Bangkok. They also assisted in pharmaceutical market surveillance by providing the operation with genuine samples for forensics comparison (with suspected counterfeits). Targets The meeting also agreed that, this being the first operation of its kind for many countries, to aim for medium-level targets. These were realistic targets that were achievable during the first year of Operation Storm. Operation The overt phase of Operation Storm will last for six months, commencing on 15 April and closing on 15 September 2008. 4
5. Pharmaceutical Market Surveillance Anther component of Operation Storm is to carry out pharmaceutical market surveillance in participating countries in order to enhance field intelligence which will aid future operations. The intention is to build up a regional library that participating countries can contribute to, and in the future, refer to, during investigations into counterfeit pharmaceutical crimes. A total of 110 samples were submitted to the HSA Criminalistic Laboratory in Singapore to testing. These samples came from 6 countries (Cambodia, Indonesia, Laos, Myanmar, Thailand and Vietnam) and two manufacturers, Eli Lilly and Sanofi. Five drug types were submitted: Antimalarials (22 different kinds) represent 66% of the samples; Erectile Dysfunction drugs represent 16% of the samples; and Antibiotics, Antipsychotics and Antiplatelets made up 18% of the samples. A graphical breakdown of the types of samples submitted is as follows: Samples Summary Breakdown Erectile Dysfuction, 14, 16% Antibiotics, 6, 7% Antipsychotics, 6, 7% Antiplatelet, 3, 4% Number of Samples* Received per Drug Type Drug Type, Number of Samples,* Overall Percentage Antimalarials, 56, 66% * 'Samples' as defined by FCPL sampling methods. Despite the relatively small sample size, the laboratory has established some linkages among samples seized from the same country. Samples of controlled drugs sold illegally were found to have approximately the similar chemical constituents as genuine samples. This either suggests the existence of high-quality counterfeits or a grey market trading in genuine, though illegal, pharmaceuticals. Work in this respect is currently on-going by the HSA laboratory, and will carry on through the next operation. 6. Operational Outcomes The overt phase of Operation Storm commenced on 15 April and ended on 15 September. Prior to the operation, participants agreed that intelligence would be submitted to the Operation Storm Coordination Team (comprising of representatives from INTEPOL and WHO) for collation and analysis. Representatives from WCO also 5
organized an intensified control operation among the participants from Customs, which was carried out from 1 to 14 September 2008. Outcomes in Countries In Myanmar, an Intensified Control Operation was organized with about 56 Customs personnel who conducted over 150 checks in 10 selected points across the country. 3 seizures of unregistered pharmaceuticals were made. Intelligence from Myanmar indicates that counterfeit anti-malarials sold in Myanmar are known to be produced in Thailand. The Thai-Myanmar border area also serves as a transit point for these counterfeits to be supplied to other countries. Myanmar authorities also learnt that amphetamine-type stimulant drugs, as well as other types of medicines such as cough tablets and common remedies, are also produced in this area. They have also determined that the ingredients of these counterfeits are harmful to consumers. This area is also believed to produce precursors, which are the key chemicals for the production of counterfeits. The Thai Food and Drugs Administration (FDA), along with their counterparts from the police, conducted 20 raids during the operation, which resulted in 16 arrests, of which one was a Chinese national. About 96,432 tablets, consisting of 83,260 tablets of Viagra, 12,148 tablets of Cialis and 1,024 tablets of Levitra, were seized. The estimated value of these seizures amount to about US$650,664.00. In Vietnam, counterfeit pharmaceuticals are usually bought and sold at border areas such as Langson, Quangninh, Quangtri and Tayninh. Smugglers often carried the drugs in small quantities in order to avoid detection. This also enables smugglers to quickly dispose of the goods to avoid law enforcement officials. During this period, custom agencies found and seized about 53,720 tablets/capsules with unclear name(s) and origin. Vietnamese Customs also organized an Intensified Control Operation from 1 to 15 September 2008 at crucial border points such as Noibai Airport, Tansonnhat Airport and Haiphong Port. No counterfeits were found. However, Vietnamese police were able to detect and seize 8 cases, consisting of 14,000 tablets of Viagra and Cialis, 514 blister packs of Viagra with 2 tablets in each pack, 5 boxes of Viagra with 30 tablets in each box, 170 blister packs of Cialis with 30 tablets per box, 75 boxes of Levista, 106 boxes of Rovanten, 200 boxes of Vinka, 43 bottles of Amoxicillin, 1,022 bottles of Augmentin, and other pharmaceutical paraphernalia. Outcomes from Private Sector Partners Large amounts of counterfeit Duocotexcin and Cotexcin were discovered in Kenya. It had been established that these anti-malarials were made in China. In April and September 2008, raids by the Public Security Bureau (PSB) of China discovered, in the Southern city of Zuhai, 16 million counterfeit pills, with an estimated worth of about US$6 million, of different varieties. 6 Chinese nationals were arrested. 6
This case is strongly believed to be linked to a group based in Chinese Taipei. The group is known to supply a wide variety of counterfeit pharmaceuticals through their extensive international supply networks. PSB is currently working with their private sector partners to investigate further. Open Cases The private sector handed over, through INTERPOL, seven cases. Investigations are still underway on these cases and will continue into Operation Storm II in 2009. 7. Findings Efficacy of Training Sessions Operation Storm has provided training to Customs, Drug Regulatory Agencies and the Police in Thailand, Vietnam. Based on the course feedback, trainees were positive and many have indicated that the training was highly relevant to their work. The efficacy of the Operation Storm training, both as a morale booster and as an opportunity for officials from different agencies to meet, cannot be underestimated. Prevalence of counterfeit Erectile Dysfunction (ED) Drugs ED drugs such as Viagra, Cialis and Levitra constituted most of the counterfeit pharmaceuticals seized. There may be two explanations for this outcome: firstly, ED drugs have brand recognition and pharmaceuticals companies, through the Operation Storm training sessions and through their own efforts, have successfully passed on counterfeit identification techniques to law enforcement officials; secondly, following market demand, ED drugs are the drug of choice for counterfeiters, and the scale and extent of their production now far exceed the other classes of drugs. Seizures of Medicines Previously Identified as Priority Counterfeit anti-biotics (Augmentin) was discovered in Vietnam, while large quantities of China-made anti-malarials were found in Africa. This is in line with expectations because during planning meetings, countries identified classes of medicines that were readily counterfeited and posed significant public health risks. Anti-Malaria medication and antibiotics were among the classes of medicines identified. Evidence of Transnational Linkages There are some indications of transnational criminal networks at work. For instance, the large amount of China-made anti-malarials in Africa is highly indicative of an Asian- African supply chain. One of the raids made in Thailand also resulted in the arrest of a Chinese national. In addition, in cases that remain open, there are further indications of transnational networks. 7
8. Recommendations The following, stemming from the findings above, is a list of recommendations for the next operation: 1. IMPACT Enforcement Training to be provided to all countries prior to the overt operation. Advance enforcement training to be given to countries which have undergone the basic training. 2. ED drugs would be included in the list of priority medicines to be targeted during the next operation. 3. Additional cases would be developed to specifically target medicines previously identified as priority. 4. Participants would follow-up on open cases. 5. Participants would alert Operation Storm Coordination Team about transnational elements during case investigations. 6. Senior management from the Customs, Drug Regulatory Agency and the Police of each participating unit would be invited to a strategic-level meeting prior to the commencement of each operation in order to formally commit to the operation and to agree on protocols involving multilateral intelligence sharing. 7. WPRO would organize a meeting with anti-malarial control disease programme managers. 9. Conclusion Operation Storm is able to exploit the intelligence dividend arising from previous operations in that it has convinced countries in the Greater Mekong Sub-Region about the danger counterfeit pharmaceuticals pose to public health and safety. To this end, countries of the region have banded together under the Operation Storm umbrella to take concrete action. To this end, Operation Storm is unprecedented at both the national, regional and international level. This is the first time that three national agencies Customs, the Drug Regulatory Agencies, and the Police are working together to conduct joint operations for counterfeit pharmaceutical crimes. Also for the first time, seven Asian countries have recognized the common threat that counterfeit pharmaceuticals pose and have come together to tackle this problem. Also unprecedented, at the international level, is the cooperation among INTERPOL, WHO and WCO to fund and to coordinate operations. The systematic partnership approach, at the national, regional and international level, that INTERPOL and its partners have taken pains to set up will enable them to build 8
trust, gain expertise and establish strong working relationships that will serve them well as this operation moves into the next phase. 9