Pharmaceutical regulation

Life sciences work is the lifeblood of Covington & Burling's London office. Here's a closer look at pharma regulation.

 

There's no denying that pharmaceutical companies and the products they create are vital to global healthcare. But it's one contentious business. The industry has been accused of various ignoble activities over the years, among them: deploying questionable marketing tactics, ripping off the developing world, and making profits off the sick and vulnerable. In fact, in March 2016, President Francois Hollande stated that he hopes to persuade G7 partners to introduce global pricing regulation for pharmaceutical products. Regulation is urgently needed due to recent huge increases in medicine costs, although manufacturers defend their high profits by arguing that price cuts will force them to cut their research. While a major pricing alteration is unlikely, some companies have stated that they are hoping to adopt a graded pricing system, depending on the average income in a particular country. And then there are the products themselves: useful, but potentially dangerous.

It's no surprise, then, that a whole host of regulations cover the industry. In Europe, medicines are regulated at EU level; both to ensure high standards of drug safety across the entire continent, and to enable the pharmaceutical industry to trade freely across the single market. As one Covington trainee who'd worked in the firm's life sciences regulatory group reported, “you pick up lots of EU law research skills, as the industry is regulated on a European level.” In the UK, these rules have been transposed into law via the Medicines for Human Use (Clinical Trials) Regulations 2004, with further requirements enforced under the Human Medicines Regulations 2012.

So if you're a pharmaceutical company looking to launch a product in the UK, what do you need to know? Before you worry about whether you can offer samples to the public or put endorsements on the packaging, you'll need to make sure you can sell your miracle drug. The Human Medicines Regulations 2012 make it an offence to market a drug without a 'marketing authorisation.' These last for five years, and allow their holder to sell and supply medicinal products.

To get your mitts on a marketing authorisation, you'll have to submit the results of those clinical trials you've conducted. In Britain, the Medicines for Human Use (Clinical Trials) Regulations 2004 set out strict rules for how medicines should be tested. The subjects of clinical trials have to be adults, and capable of giving informed consent. Participants must be made aware of the risks and potential inconveniences of taking part, told that they can withdraw at any time, and provided with a contact point. The trial itself also needs to be approved by an ethics committee, which weighs up whether the anticipated benefits – for both the subjects and future patients – outweigh the potential risks.

It's illegal to advertise prescription-only medicines to the public, but non-prescription meds aren't off the hook either. Here's what you can't do when it comes to advertising a non-prescription product: suggest that a diagnoses is unnecessary; claim that one product is better than another; use endorsements by scientists or celebs; or aim ads at children. When it comes to packaging, you'll also have to think outside and inside the box: your packaging must say everything it should about the product, and nothing it shouldn't.

Medicines play around with the internal processes of the human body and can be unpredictable: it's therefore impossible for clinical trials to flag every conceivable risk or adverse effect. This is where pharmacovigilance comes in. This isn't just a cool word to drop into conversation at parties (although by all means do). It also refers to the ongoing monitoring of existing drugs in order to spot new safety issues as and when they pop up. The Medicines and Healthcare Products Regulatory Agency (MHRA) can make marketing authorisations conditional on ongoing pharmacovigilance. What's more, both the MHRA and the European Medicines Agency (EMA) can order companies to make changes to their monitoring systems. Take note, as failure to comply is a criminal offence.