How different is obtaining regulatory approval for generic medicines in Europe compared with patented drugs? And, how best to proceed when it comes to translating generic medicines’ product information, such as the Summary of Product Characteristics (SmPC) – a necessary step in the European regulatory legislation?
Is it a win-win?
A slightly wider perspective first. Much has been written about the patent cliff that many producers of drugs are facing globally, as they see their patents (in many cases of major blockbuster drugs) expiring and the revenue from their patented drugs decreasing. In Europe, generic medicines represent just under 50% of the whole pharmaceutical market by volume, but only about 18% of the total cost.
As the healthcare budgets in most European countries are coming under strain, it is no wonder that the producers of generic medicines see the doors increasingly open wide for them. The number of generics authorized in Europe is also on the increase (see the chart below showing the generic medicines authorized using the European Medicine Agency’s centralized procedure over the past few years).
Source: The European Medicines Agency
In fact, according to the European Generic Medicines Association (EGA), 83% of all authorization applications via the Decentralized Procedure (DCP) are related to generics. In the case of all Mutual Recognition (MRP) applications it is 68%, and almost 50% of applications in the Centralized Procedure (CP) are related to generic medicines.
But despite the rise of generics, 2012 wasn’t a bad year for the global pharma industry either. And the prospects for 2013 are looking good. The global new drug approvals are up, the overall pipeline looks promising and some of the drugs in the pipeline have high potential sales estimates. In Europe, for instance, Deutsche Bank estimates there are some 60 drugs in the pipeline from 2013 to 2015, with a sales potential of $64bn. This compares well with the estimated $27bn of revenues lost due to patents expiring in the same period.
The regulatory perspective
One of the goals of the European Generic Medicines Association is to “improve patient access to affordable medicines through better regulation.” The association suggests a few ways of achieving this goal. Two of these are:
- Quicker access to generic medicines by refining the Decentralized Procedure and incorporating certain elements of the Centralized Procedure, such as “a single list of questions, clear rules for restarting the procedure after clock-stop, and clarity within the decision-making process when disagreement occurs.”
Clearly, this is designed to accelerate the market authorization process in the countries where the administrative procedure of issuing the final document takes too long. In this case, medicines could be placed on the market just based on the positive closure of the DCP European Phase, and of course, approved translations of the medicine’s product information.
- Improved access to generics by using the Centralized Procedure. The CP is very attractive to many manufacturers of generics since it allows a single application, a single evaluation and a single authorization resulting in a direct access to the EU market. Right now, access to the Centralized Procedure for generic medicines is limited by legislation.
Generic medicinal products of a centrally authorized product qualify automatically. Those of medicinal products authorized via the national, MRP or DCP procedure can be considered for the CP, if they constitute “a significant therapeutic, scientific or technical innovation,” or the centralized authorization is in the interest of patients at Community level. In this regard, the EGA’s dreams have come true already.
How to go about translating SmPCs for generics? In many ways, translating product information for generic medicines is no different from translating patented medicines. But there are a few practical considerations, looking at the Centralized Procedure as an example:
1. Be consistent with the reference medicinal product’s SmPC…
The general rule is that the product information product materials, such as the Summary of Product Characteristics (SmPC), should closely follow – where possible and relevant – what already exists for the reference medicinal product. Such a drug would be already authorized via the EMA and so its translated product information is freely available on the EMA’s website for all the languages required during the Centralized Procedure. Using this as a reference is a must.
The focus here is on consistency between the generic and patented drugs. This applies already at the stage of developing the source SmPC, where the EMA promotes consistency except for indications or dosage forms that would be still covered by patent law.
2. …but use the latest QRD templates
The translated SmPC should use the current versions of the local-language QRD templates available by the EMA. This means that while the reference medicine may use an older QRD template, even the latest version filed with the EMA during its patented period on the European market, the product information should follow the current template. This will necessarily involve careful word-by-word review of the existing translated product information of the patented medicines, and comparison with the latest QRD template for the given language.
On the positive side, the English source will have undergone the same process, enabling a comparison of the extent of changes made to the source QRD version by the generic drug manufacturer.
3. Watch out for the generic manufacturer’s specifics
While generic medicines contain the same active substances as their reference medicines, and are used at the same dose to treat the same disease, they are not the exact replicas. So it is crucial to watch out for all the differences between them in the actual SmPC. Examples include the inactive ingredients, or ‘excipients’, the name of the medicine, its appearance and description, and its packaging, which all can be different from those of the reference medicine.
4. Take the big picture, don’t get lost in trivia
Since so much about the generic medicines is modeled on their reference drugs, it is easy to get lost in the process, and be too focused on spotting, analyzing or “reading into” any differences. While consistency is critical, it is important not to lose sight of the core objective – providing accurately translated product information that complies with the current European legislation, and uses the approved templates, “language” and terminology. This is all about regulatory approval and, ultimately, ensuring patients’ health and safety.