A new regulation that we should be pleased with!

Paul Gershlick explores the Falsified Medicines Directive.

As a lawyer, I often plead with people: “Don’t shoot the messenger!”

So, rather like the weather presenter warning of torrential storms, I ask readers to be kind with me if there is a new law that you do not like. It is not my job to create the law, but to help businesses through the law!

There are many laws that have good intentions behind them such as data protection, but sometimes businesses understandably see them as red tape and a nuisance. When it comes to matters of life and death, though, we should be even more understanding of the purpose behind regulations.

You could take the developments with the new EU laws on clinical trials or pharmacovigilance. But I want to focus in this piece on falsified medicines.

It’s easy to lose sight of why the Falsified Medicines Directive is there, when we consider the disruption, including the ability to important active pharmaceutical ingredients from certain countries outside of the European Union.

So what are falsified medicines? These should be distinguished from counterfeits. Falsified medicines are fakes. They are purported to be authentic and authorised, but are not. This could be because they contain contaminants (i.e. other ingredients), or the active ingredient is of poor quality or the wrong dosage or strength or even not present at all.

An active ingredient could be falsified in terms of identity (such as the name or composition of the item), source (such as the country of origin or marketing authorisation holder) or its history (its distribution records).

“It’s easy to lose sight of why the Falsified Medicines Directive is there”



It is a growing problem. At least 10% of medicines sold around the world are thought to be falsified, and a significantly larger proportion for sales through the growing medium that is the Internet. The reason why this matters is people are suffering or even dying. It is a real problem and not just about stopping big pharma companies losing some of their profits. It is ultimately about patient safety.

One of the really interesting points is that people may dismiss the problem as being largely limited to lifestyle type drugs such as Viagra. But this is not the case. The problem is felt across all therapeutic areas, including over 40% in antibiotics. We are talking about important medicines such as for cardiovascular diseases, cancer and antibiotics that are being increasingly falsified. Falsified medicines are dangerous because either the drugs that are supposed to help patients with critical conditions do not work or, worse still, they could potentially do even more harm.

So what is contained in the Directive? There are four pillars within the legislation. They are: safety features of medicinal products; supply chain and good distribution practice; API and excipients; and Internet sales.

Key changes include greater responsibility on the supply chain, additional classes of people who are subject to the regulatory regime (such as brokers, who do not take possession of the drugs) and greater rights to inspect.

One way in which the legislation has been particularly felt so far is with the restrictions on importation of APIs from countries outside of the European Union.

Manufacturing authorisation holders are legally required to audit (or have audited on its behalf) manufacturers and distributors of APIs used in their products.

A big area of concern for industry has been the ability to import APIs from countries such as India and China, which have had a growing market share in the supply of APIs. Industry has been worried that there would be a shortage of medicines if APIs were restricted from these countries.



“At least 10% of medicines sold around the world are thought to be falsified…”



Non-EU countries can apply to the European Commission for an assessment that the standards which are applied to manufacturing active substances in their countries enable them to be included on a white list, thus amounting to deemed compliance with rules equivalent to those applied in the EU.

If a country is not on that white list, an organisation importing the active substance into the EU needs to obtain written confirmation from the competent authority in the exporting country of compliance with standards equivalent to the EU.

Exceptionally, an EU authority may conduct its own inspection of a factory outside of the EU to give it the all clear.

The concern is that so few countries have so far made it onto the white list.

These parts of the Directive were implemented into UK law in August 2013. But the good news is that regulatory authorities in the EU have so far taken a pragmatic line. They have not sought to ignore the Directive, but they appreciate the difficulties faced by business.

There are further provisions of the Falsified Medicines Directive that will be implemented in the coming months, such as authenticity features on packaging and trust marks for Internet sales. So we are still on this journey of regulatory change.

The rules are setting important lines in the sand that businesses should adhere to. But all this is there for good reason – to protect patient safety because of a real and serious problem.

So, if you don’t agree with me on this one, feel free to blame the messenger! It’s not my fault the law is there, but I back its rationale!

The next article by Paul Gershlick ‘Refusals to supply in the EU’s pharma industry – is it legal, and what about patients?’ can be viewed here.



About the author:

Paul Gershlick is Partner and Head of the Pharmaceuticals and Life Sciences team at Matthew Arnold & Baldwin LLP; he can be contacted using the details below:-

T: +44 (0)1923 208816

F: +44 (0)1923 215004

E: Paul.Gershlick@mablaw.com


Do you back the rationale of the Falsified Medicines Directive?