The European Medicines Agency is the FDA’s alter ego, but there are special regulations challenges for pharmaceutical PR executives.
The theme of doppelgangers can be found in a few of Stephen King’s novels, so it seems fitting to spin a ghostly tale to get in the spirit of Halloween. And this is truly a scary story for marketing pros trying to get a grasp on global compliance issues related to pharmaceutical communications: You’re about to meet the FDA’s not-quite-mirror-image twin, the European Medicines Agency (EMA).
The EMA fits the definition of a doppelganger because it’s eerily akin to the FDA, yet it bears its own unique authority and functions. Fortunately for healthcare PR specialists, there are enough similarities that make the regulatory landscape familiar, so compliance isn’t a nightmare that leaves you in a cold sweat.
Background & Authority: The EMA was established in 1995, funded jointly by the European Union and the pharmaceutical industry, with some subsidies provided by the member states. The intent was to bring existing national regulatory agencies into closer alignment to accomplish two goals:
- Reduce the exorbitant amount pharma companies were spending to gain approvals from each EU member nation; and,
- Open the doors to competition, as some nations had been using protectionist strategies to delay or cease approvals from companies competing with enterprises within their own borders.
Like the FDA, the EMA’s authority extends to the marketing activities of pharmaceutical companies in addition to its approvals functions. But unlike the FDA, the EMA offers options for gaining authorization to market products: a centralized approach and a national route. Here’s how they work.
Centralized Authorization of Marketing Materials: With this option, pharmaceutical PR teams submit a single authorization application to the EMA. The agency’s Committee for Medicinal Products for Human Use conducts a scientific assessment of the application and makes a recommendation - giving a thumbs up or down on whether the drug should be marketed or not. The EMA recommendation heads to the European Commission, who will grant or deny the application.
If granted, the centralized marketing authorization is valid in all EU member states.
National Authorization Procedures: Each EU member state also has its own approvals and marketing authorization procedures, which apply for drugs marketed, sold, and produced within their respective borders. Going this route may be necessary for healthcare communications that fall outside of the centralized authorization procedures, but you can imagine the expense if you want to market a product throughout the EU. There is another option, the Mutual Recognition Procedure, allowing you to request that EU nations recognize the authorization gained in another member state.
Compliance with the EMA’s regulatory scheme doesn’t appear so scary, right? You have both centralized and de-centralized options, and can even gain mutual recognition in certain cases. Well, get ready for the unexpected plot twist to this horror story. With Brexit, the future of the EMA is in a state of limbo. The EMA is currently housed in London and may soon be homeless. Drugs currently under review may not feel an impact yet, but the regulatory process may experience some bumps in the road in the future.
Which brings to mind the best part about a scary movie: You CAN turn it off. In the case of compliance for pharmaceutical communications professionals, it’s the equivalent of turning things over to your legal department. Regulatory can be intriguing to learn about, but you don’t want to lose any sleep over it. If your campaigns will be touching on EMA compliance, put your trust in legal.
Keep an eye out for our next installment in our Regulatory Series pharma PR:
The FDA speaks on correcting third party information AND The Anatomy of an FDA approved Tweet.
By Marc DeLeuw