Assessing the Impact of Globalisation on Pharmaceutical Counterfeiting
Jeffrey Gren, Director of the Office of Health and Consumer Goods, joins Pharma IQ to address some solutions to the increase in the volume and the level of sophistication of counterfeiting as part of the impact of the globalisation of the pharmaceutical industry.
Pharma IQ: You'll be a speaker at the upcoming IQPC Anti-counterfeiting for Pharma and Medical Device Conference. Can you give us a brief overview of what topics you'll be speaking to?
J Gren: Well, the topic of the presentation is the impact of globalisation of the pharmaceutical industry. The globalisation of the pharmaceutical industry has impacted the counterfeit medicines problem globally.
Factors that I'm going to be covering is such as the movement of generic and other manufacturing from a traditional dominance in the Unites States and Europe to overseas locations such as India, China, Southeast Asia, Brazil, Mexico and other locations, and I'm also going to talk about how the growth in manufacturing of active pharmaceutical ingredients has exasperated this problem since, once again, most APIs used to be made in the United States and Europe, and now over 60 percent are made in India and China, which experts predict will grow to 80 percent.
I'm also going to be talking about some of the mitigating activities that are going on related to counterfeit medicines around the world, such as initiatives in APEC and different global forums around the world, and some of the work that we're doing, specifically in China and India, and then, finally, I'm going to conclude by saying that the only way to effectively deal with the global problem of counterfeit medicines is through cooperation of countries, cooperation related to regulatory enforcement issues, cooperation on customs, and the industry also has a very significant role here.
One of the facts that is very disturbing is that the amount of counterfeit medicines in the world continues to increase each year, and although there are a number of global activities being done and in the works the number of counterfeits is continuing to go up, and I hope that in the near future we will start seeing reductions.
Pharma IQ: Now, you mentioned the impact of globalisation on the pharmaceutical industry. What has been the impact from a counterfeiting standpoint?
J Gren: Well, one of the problems is that we're seeing more and more manufacturing in locations without strong regulatory regimes or strong pharmacopoeia standards, and we're also seeing, as I mentioned earlier, manufacture of APIs and excipients in foreign locations, and just focusing on the API issue, one of the things that we're seeing is APIs that are being manufactured in countries without strong regulatory regimes, and these APIs are then in turn used by counterfeiters, either in that country, or the APIs are shipped to other locations where counterfeiters are producing the counterfeit medicines, which has very severe health consequences.
Pharma IQ: And what increasing levels of sophistication are you seeing?
J Gren: Well, a few things to keep in mind here. One is that counterfeiting is done by criminals, and the reason that they're doing the counterfeiting is because there are high profits. Profits for counterfeit medicines are significantly higher than profits for narcotics, and the extent of penalties is not as severe as narcotics in most parts of the world, so there's clearly a need for better enforcement and laws that punish counterfeiters to a higher degree, based upon the public health impact.
We're also looking at counterfeits as a public health problem, and one of the things that we are seeing which is disturbing is that more and more counterfeits are being distributed through the internet, and more and more counterfeits actually have real APIs in them, and what's scary about this is counterfeiters are making the counterfeit medicines, so to the consumer they're perceived to have some medicinal value.
Now, we contend, of course, that all counterfeit medicines are unsafe because there are no clinical trials, there is no regulatory oversight, there is no coherence to good manufacturing, there's no sterility, and if you look at some of the pictures of counterfeiters that have been arrested it clearly shows unsanitary conditions, and just back to your question: one of the things we're also seeing is a very high level of sophistication in some of the counterfeiters, and if you look at the products side by side it’s very hard to tell without detailed analysis that the pill is a counterfeit or the labelling is a counterfeit, and very often it needs laboratory screening, and that is another thing that we've been focusing on, is the use of detection technologies as one of many tools to try to control the entry of counterfeit medicines in the market, or to get a better control over what medicines are being sold in pharmacies, and there are a lot of advancements that have been made related to detection technologies.
Pharma IQ: And what strategies can companies use to track down counterfeiters?
J Gren: Well, many companies have... many of the larger pharmaceutical companies have security units that are clearly looking at this problem. They're doing investigations, they're cooperating with law enforcement, and these are all good initiatives, but clearly what is needed is more of a global focus on the counterfeit medicines problem, more cooperation of regulators, customs, law enforcement, industry working together, and there are some very good initiatives that are taking place.
Interpol, which is an organisation of police enforcement around... and it’s a global organisation, they have done some very good work in this area, and the World Customs Organisation has done work, so there are some good things going on, and I think we need to build upon those, but it’s a difficult global problem, and it’s going to take a concerted effort to make a significant impact.
Pharma IQ: Can you outline global activities to address the counterfeit medicine activity?
J Gren: Well, there are quite a few activities in process, and I'll just highlight a few that I'll go into more detail during my presentation. Under APEC, which is Asia Pacific Economic Cooperation there is a Life Science Innovation Forum, and we've been working with the US FDA, other regulatory authorities, and industry for a number of years addressing the counterfeit medicines problems in APEC, which is a very good forum because it includes 21 economies and it is a very significant share of global trade, and we had a series of seminars in APEC specifically looking to the counterfeit medicines problem.
We've developed a counterfeit medicines action plan which was endorsed during 2010, and we're in the process of implementing the first project under that, which is a drug safety and detection technologies project which will take place in China, September 27 and 28, in Beijing, and this will be an APEC event, and we also hope to invite select non-APEC economies to make this more of a global event.
There are also a number of initiatives that are taking place in other organisations. There is World Health Organisation activities. There are activities that I mentioned earlier through World Customs Organisation, through Interpol. There's also US State Department activities on commercial diplomacy focused on anti-counterfeit medicine, and we're also addressing this problem as well as the API problem in our dialogue with China under the Joint Commission on Commerce and Trade.
IQPC's Anti-Counterfeiting for Pharma and Medical Devices Conference, takes place in Philadelphia May 31st to June 2nd . For more information visit http://www.anticounterfeitingpharma.com/.
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