Pest control

Protecting the public and pharmaceutical companies from counterfeit drugs is all in a day’s work for the MHRA’s Mick Deats.

“Current legislation doesn’t carry the type of penalty you need to tackle people dealing in multimillion-pound organisations, importing medicine from the other side of the world and infiltrating it into our supply chains”
-Mick Deats

Discerning whether medical devices have been breached, and investigating alleged cases is a responsibility certainly not for the faint-hearted. Mick Deats, Group Manager of Enforcement at the Medicines and Healthcare products Regulatory Agency, is responsible for sniffing out counterfeit medicines, and with many cases becoming criminal investigations, it’s no easy task.

The MHRA is a government agency, responsible for ensuring that medical devices work, and that they’re acceptably safe, which it does through a regime of licensing, inspection and market surveillance. The agency is exceptionally vigilant and has an intelligence group as its enforcement to tackle any allegations that are made regarding medicine and the law.

“There are cases referred to us by members of the public, other regulatory bodies, law enforcement, healthcare professionals, patients; there’s a whole range of ways that referrals are made into the agency. In my particular unit, we receive around 1500 referrals a year, which are assessed and a proportion of them will become criminal investigations,” says Deats.
The discovery of this is usually through reports to the agency, via members of the public reporting suspicions, or reports from others working within the supply chain. Also, on-site inspections have led to numerous discoveries of counterfeit medicine; and once these have been found, MHRA works quickly to protect public health by launching a full and very detailed criminal investigation, with a view to prosecuting those involved.

“We’ve run counterfeit hotlines here, and there are methods for people reporting any suspicions through our website. We’ve seen numbers rise due to people’s awareness increasing. We always encourage that. If people have got suspicions about their medicine then it can always be reported through to us very easily from the front page of our website or on the phone to a counterfeit hotline,” explains Deats.

Organisational structure
The MHRA is made up of 10 divisions, with approximately 900 staff, 45 of those compiling the enforcement group. Every European country has a medicines agency, but the UK is quite unusual in terms of the enforcement and intelligence group being substantially larger than other countries.

“Counterfeit medicines in Europe, but specifically in the UK, arrive in two different ways. Firstly, and most commonly, it’s through unregulated internet websites that could be hosted anywhere in the world, who make their products available to anybody in Europe or in the UK.

“Then the less common way of counterfeits reaching patients is through the regulated supply chain, and that’s through licensed wholesalers and pharmacies. Fortunately, that is a very rare occurrence, but nevertheless, since 2004, it’s led to nine recalls of medicines here in the UK. There’s a high degree of confidence in the medicines you obtain from a pharmacy. So anything that damages that confidence is a really bad thing to occur,” he says.

The MHRA focuses much of its attention on the counterfeits trafficked through internet supply. However, with the internet being completely open and continuing to expand, this is no easy task, and the difficulty of defining the lines of jurisdiction adds to the already existing problems.

“If the websites are hosted in the UK or the medicines are being supplied from within the UK, that brings it within our jurisdiction, which we can investigate. If necessary we can prosecute the case, which we have done on a number of occasions. But if the website is hosted elsewhere in the world, then it’s not within our jurisdiction, and so we pass that information to the relevant authorities. It’s up to them as to what action they take.

“It’s a challenging area. Our focus is to give the public sufficient information to make an informed choice as to whether it’s a good idea to be obtaining your medicines from unregulated websites, which is why we’ve begun the advertising campaigns.”

Through a recent series of advertisements screened in cinemas, the MHRA, in conjunction with Pfizer and several patient associations, is raising awareness among the public of the risks of purchasing counterfeit medicines. The World Health Organization recently issued statistics suggesting that up to 50 percent of medicines supplied from websites that conceal their physical address are counterfeit.

The ad was aimed at persuading people not to buy drugs from the internet or other dubious sources. The message was delivered to the public through a very hard-hitting campaign, which in turn, attracted a lot of interest. “We were pleased to see that hard-hitting approach,” says Deats. It’s what was required. And when you look at other ad campaigns that are trying to increase public awareness about risks, you generally see that they have to be hard-hitting for you to remember them, and this one certainly was. It was shown in cinemas to age 15 and above, which is our target audience.”

Legitimate leaks
Another increasingly worrying issue is the issue of counterfeit medicines leaking into legitimate supply chains. “We’ve seen it happen in the past, where unlicensed traders or brokers are feeding counterfeit medicine into people who are authorised to trade in medicines in the supply chain. These traders have either been duped or turned a blind eye, or are criminally involved and knowingly inserting that into the supply chain for profit,” explains Deats.

“We tackle that type of thing firstly by taking steps to ensure that the product is seized or quarantined and prevented from getting out to market. However, if it has got out to market, then that’s when we consider issuing a recall notice and getting it back and getting it taken off the shelves.”

How can companies protect themselves against fake drugs making their way into the supply chain? Deats explains that most of the large drug companies have large security departments that are devoted to tackling those people that are infringing their intellectual property rights. This often leads to an overlap between intellectual property rights issues and public health issues. However, MHRA do not function to protect brands, but solely public health, unlike pharmaceutical companies, who can also seek to protect their brands.

This angle of brand protection enables prosecutions from investigations to be done using a combination of medical, intellectual property and money laundering legislation, to ensure the courts have a full report of the criminal activity with which to pass the sentence.

“It allows the court to deal with the case in an appropriate manner, and the maximum sentence under the medicines act is two years in prison with unlimited fine. The maximum sentences under trademark legislation are 10 years, and the money laundering is 14 years. So we don’t restrict ourselves by purely dealing with them on the medicines legislation.
“Currently, the European Commission and our agency have just completed the public consultation process on measures to tighten the supply chain, and part of the recommendations of this are the need for specific criminal offenses to tackle counterfeit medicine, because at the moment we rely on Medicines Act legislation. This doesn’t carry the type of penalty that you need to tackle people that are dealing in multimillion-pound organisations, importing medicine from the other side of the world and infiltrating it into our supply chains.

“Obviously, we’re keen to get the message out about public safety and the risks attached to obtaining your medicines from the internet. We would always advise people to have a face-to-face consultation with a healthcare professional and obtain their medicines with a prescription.

“And as far as the internet’s concerned, we’re very keen to get the message out to the public because the internet wasn't originally designed to be regulated, and because of its global nature, it’s extremely difficult to deal with. The people that run these operations realise that it’s a wise move on their behalf to host their websites in countries that are difficult to do business with.”