Permanent Forum on International Pharmaceutical Crime

 Auckland Tuesday 5 May 2015.

Tena koutou, tena koutou, tena koutou katoa. Greetings, greetings, greetings to all and every one of you. It is with great pleasure that I welcome you to New Zealand and thank you for making the lengthy journey to be here. New Zealand’s Ministry of Health (Medsafe) and The Therapeutics Goods Administration of Australia are proud to be joint hosts for this meeting. New Zealand and Australia have a long and proud history of mutual co-operation.

The safety and effectiveness of our medicines and medical devices is something we take for granted. We expect the supply chain that delivers medicines to our pharmacies and into our homes to operate with high integrity. We just do not expect to see counterfeit medicines.

For those who may venture to purchase from alternative sources or from the internet, of course it is tempting to believe what is being said about these products, and to believe that they too are legitimate; after all, “won’t someone prevent dangerous and illegal products being supplied?” But unfortunately, there are unscrupulous minds at work seeking to make a quick buck at the expense of others.

Like you, I am concerned by criminal involvement in the supply of falsified medicines and medical devices, and the inroads that they are making into the legitimate pharmaceutical supply chain. This is a problem that affects all of us; from the supply of defective, harmful, toxic, counterfeit products to developing countries relying on these as essential medicines; to the sophisticated manipulation of well-regulated markets in order to make money from fraudulent activities.

The internet is a tool used by these criminals to fool unsuspecting consumers, some of them desperate for an elusive cure or remedy, into paying money for worthless and potentially harmful products. At the centre is the patient / consumer and my interest is in using resources as effectively as possible to provide as much protection to our people as we can.

This is where you come in.

As a collaboration of international regulators you are addressing this global problem. With your approach to sharing information, and pooling resources you can generate effective outcomes that have a real benefit in our communities. As you are aware this international enforcement forum is aimed at exchanging information and ideas to foster mutual co-operation in combatting pharmaceutical crime. The inclusion of the International Laboratory Forum on Counterfeit Medicines within the PFIPC brings important scientific and forensic expertise to the arena. You have a comprehensive and interesting programme ahead of you, which includes presentations from: • your colleagues, who are experts in their fields; • industry representatives, who make a valued contribution to the investigation of pharmaceutical crime, and from, • external speakers including from the New Zealand National Drug Intelligence Bureau.

Also included are; discussion groups, planning for this year’s international internet week of action, and the creation of your strategic plan for the next five years. A full agenda indeed.

In New Zealand we are seeking even greater collaboration between enforcement agencies to achieve efficient outcomes. We are a small country with limited resources so our approach in many areas is to do as much as we can through collaboration and cooperation.

With this in mind, the Medsafe Investigation and Enforcement Team works closely with its key stakeholders, the New Zealand Customs Service and the New Zealand Police. The team is justifiably held in high regard for its collaborative working relationships.

I understand that your established communication networks ensure rapid communication and response between your members, ensuring that international action can be taken in an expedient manner at short notice. Your trans-national approach enables you to address a global problem even more effectively. I also understand that contacts made through the PFIPC have been the spark that has ignited several multi-national investigations. I am proud that New Zealand has played a part in those investigations. I also commend you for your collegial engagement with industry. Industry has a stake in how pharmaceutical crime is addressed and mutual interest and collaboration can be an enormous benefit.

I expect the Pharmaceutical Security Institute will provide an effective bridge between the pharmaceutical companies and government agencies. The PSI’s ability to conduct research, gather intelligence, interact with pharmaceutical companies’ investigation divisions, and share this with government enforcement agencies is an essential component in the fight against pharmaceutical and related crimes.

Maintaining the integrity of the New Zealand pharmaceutical supply chain is critical to ensuring that New Zealanders have access to safe medicines. So far New Zealand has been fortunate that counterfeit medicines have not entered our legitimate supply chain. This is partly due to our small population, our isolation and our tight regulatory controls around medicines. However, it is most important that we remain vigilant.

Unfortunately New Zealand is not immune to the rising tide of falsified medicines being sold through the internet. The widespread use of the internet has created an environment for pharmaceutical crime to operate virtually anonymously outside the jurisdiction of individual countries.

Of the 12,000 plus parcels inspected by Medsafe at the International Mail Centre last year, at least 50 percent were believed to be ordered over the internet. Around 30 percent of those medicines were for the treatment of erectile dysfunction indicating that lifestyle medicines are a popular purchase.

Other areas of concern for New Zealand are adulterated medicines. We see regular importations of these for both commercial and personal use. The fact that these are potent medicines masquerading as natural products is a substantial hazard to the purchaser. We operate an adulterated medicines testing program and maintain a database incorporating products that we have tested and product test results from other countries.

Performance and Image Enhancing Drugs (PIEDs) continue to remain a matter of concern with several recent prosecutions in New Zealand. The offenders have imported the active materials, manufactured (in totally inadequate conditions) injectable products and tablets, and then sold these products. In one investigation PIEDs with a street value in excess of one million dollars were seized.

Medsafe’s involvement is sought after by the Police for its expertise and advice in this arena.

Education is an important preventative avenue that Medsafe pursues, including the provision of articles for medical professionals’ publications highlighting the risks of medicine ordered online. It also conducts training for NZ Customs staff.

One of the objectives that Medsafe has for this meeting is to gain ideas and insights from you as to how we in New Zealand can continue to keep our supply chain safe, and also ways to increase awareness of the risk posed by pharmaceutical crime to the public and other government agencies. I look forward to you contributing to these objectives.

Your input is particularly important as we have commenced a process of modernising our therapeutic products legislation and we recognise the importance of ensuring a sound regulatory scheme backed by robust enforcement measures. As much as possible, we would like to future-proof the new legislation to accommodate changing trends in product types, distribution channels and ways of delivering health care; and at the same time take account of ways these can be exploited through criminal activity.

Medsafe is committed to keeping abreast of the issues surrounding pharmaceutical crime. New Zealand’s membership with the PFIPC keeps Medsafe informed on current issues and there is a ready source of assistance only an email away.

I thank you for that assistance.

It is also important that our staff have the skills to address this problem. I am exceedingly grateful to Dan Burke from the United States Food and Drug Administration who is staying on in New Zealand next week to conduct the two day Open Source Internet Training for staff from Medsafe, Ministry of Health, Police and Customs. This will equip our staff with the most current skill set, which will allow them to be even more effective in the global fight against pharmaceutical crime.

Edmund Burke said that “the only thing necessary for the triumph of evil is for good men to do nothing.” I am grateful that this room is full of good men and women who are dedicated to their work and committed to working in collaboration so that together we can effectively address pharmaceutical crime. I thank you for your service.

Eric, I particularly want to thank you for suggesting that Australia and New Zealand co-host this meeting and for graciously suggesting that the meeting takes place in Auckland. This meeting would not have happened without your contribution. As always, I am grateful for the close relationship between our two countries.

On behalf of the hosts, I hope that you have a productive meeting and a wonderful stay in New Zealand. Our country is a land of great beauty and diversity. I trust that you will find time to explore, meet our friendly inhabitants, and that you take home wonderful memories of your time here.