Fighting resistance

It is a tough task to keep counterfeit medicines from entering Europe's markets

In Europe at any one time, there are likely to be approximately 60 to 70 cases of counterfeit medicines in the illicit supply chain that are under investigation by the respective Member State authorities.

If Member States routinely searched for these counterfeits in their respective countries each time another informed them of a discovery, this would become a massively resource-intensive task.

Other important work would need to be put on hold while efforts were diverted to 'chasing' counterfeits that are likely not to be on the legitimate markets.

Normal procedure is to search only for a counterfeit medicine if it has penetrated another country's legitimate supply chain, or if there is specific intelligence to suggest that it may have penetrated the home market; which in the case of the Medicines and Health products Regulatory Agency (MHRA), is the UK market.

The MHRA is an Executive Agency of the Department of Health and its primary aim is to protect public health through the control of medicines on the UK market.

The regulation of all medicines on the UK market is undertaken by the MHRA on behalf of health ministers.

This is achieved through a licensing system, which assures medicines conform to acceptable standards of quality, safety and efficacy, and further ensures that licensed medicines are manufactured, stored and distributed to these standards.

Security breach

In July this year, the MHRA was informed by Dutch Customs of a counterfeit Lipitor interception, for which the associated paperwork suggested that the product was destined for the Canadian market.

Even though there was no specific intelligence to suggest that this product would be in the UK supply chain, in an unprecedented move the MHRA raised the bar in its risk assessment process and decided to look proactively for this product on the UK market.

MHRA and Royal Pharmaceutical Society of Great Britain (RPSGB) inspectors were tasked to look for the product and because this was the first time the MHRA has conducted a search in this way, only two full-line wholesalers were asked to look for the product. Within two days, the counterfeit drug was discovered in the legitimate UK supply chain.

Lipitor risk?

During the July Lipitor case, the MHRA stated that there was no immediate risk to patients presented by the counterfeit product. The assessment process which led to this conclusion involved senior MHRA medical assessors and Pfizer's medical teams closely and independently examining the results from laboratory analysis of the suspect product; this was done in association with the medicine's profile, as well as the profile of ingredients and respective usage history.

Medical experts at the MHRA and Pfizer concluded separately that the alternative statin found in the counterfeit drug had a similar profile in terms of the potential side effects and contra-indications as authentic Lipitor. Hence, as Lipitor is part of a long-term treatment regime, the counterfeit did not pose an immediate risk to patients.

In fact, the assessment in this case was backed independently by Professor Peter Weissberg, of the British Heart Foundation (BHF), who stated that: This is not an issue that should cause any worry for patients taking Lipitor.

A recall was conducted due to the fact that it was a counterfeit medicine, but it was a Class 2 Recall because there was no immediate risk to patients.

Accountability

Counterfeiting of medicines has been acknowledged as a growing problem by the majority of key stakeholders around the world. The environment now is right for intellectual investment to ensure that a balanced, proportionate and consistent global strategy is embarked upon to deal with drug counterfeiting.

The MHRA has, through collaboration with other agencies, partners and industry, already opened up this battle on a number of fronts.

Regarding accountability, the MHRA is audited by 'independent' internal auditors (Bentley-Jennison) which, at least every two years, carries out risk-based audits of each group/area of operation.

The Agency is also taking part in the European Benchmarking Project, which is a self-assessment and peer review process covering operational areas. In addition, British Standards Institution audits of compliance with the quality management system take place every six months and the MHRA is subject to audit by the National Audit Office (NAO); the last such NAO audit was conducted in 2002.

Law enforcement

The Medicines Act 1968 contains criminal enforcement provisions (not only regulatory) which ministers have a statutory responsibility to enforce.

The MHRA has in the past pursued charges under the Theft Act, Counterfeiting and Forgery Act, Trademarks Act and Patents, Copyright and Design Act. In all such cases, the MHRA liaises with other law enforcement agencies to ensure that the most suitable agency for the specific case at hand deals with it. This is common law enforcement practice.

The MHRA has also been involved in several operations with Law Enforcement agencies in other countries. There is a current ongoing counterfeit investigation, in which the MHRA has the lead role, where suspects span seven European countries, the Americas and South East Asia. Arrests are being made currently in the UK and others of these countries.

Anti-counterfeit

The MHRA is already tackling international organised crime and this capability will improve further with the arrival of the new head of MHRA Enforcement & Intelligence, Michael Deats - the current deputy of the UK Police National Hi-Tech Crime Unit.

The MHRA's anti-counterfeiting strategy was launched formally in March 2004 when the Agency noticed an increase in the levels of counterfeit 'lifestyle' medicines entering illegitimate UK markets (ie, over the internet, as well as through social gatherings).

The aim of the strategy, which is led by the MHRA Intelligence Unit (part of the Agency's Enforcement & Intelligence Group), is to implement measures that minimise the risk of counterfeit medicines reaching patients through the legitimate UK supply chain. It is a long-term effort backed by investment and commitment from a number of the UK's pharmaceutical and healthcare stakeholders.

The strategy

Strategic initiatives include: a counterfeit medicines research project (due to be published in December 2005); liaison work and training with other stakeholders at domestic, European and global levels; an 'Education and Public Information' programme; and the continual review of national legislation.

Operational initiatives include the largest medicines surveillance scheme in Europe, which was designed specifically to target 'high risk' products; inspection surveillance to detect counterfeit drugs; coordinated international enforcement action with pursuance of proceeds of crime; and crisis management systems to deal with counterfeit incidents to best safeguard public health.

Among the UK stakeholders, the MHRA is uniquely placed, as it is the only one that has no other agenda but to protect public health.

The Author
Naeem Ahmed is the head of intelligence at the Medical and Healthcare products Regulatory Agency (MHRA). For more information on the agency's activities, please visit the website (www.mhra.gov.uk). This article is a response to The Missing Leak, published in PM Europe (Autumn 2005)