2012: Is this the year of more clarity in the EU for products on the pharmaceutical / medical device borderline?

A dynamic year ahead
As we move into 2012, we are witnessing a fundamental change in healthcare product technology market demands from policymakers and consumers alike and a shift in the regulatory needs of manufacturers in this area. Pharmaceutical companies, in particular, are being challenged as technological imperatives drive forward product development.

Drug delivery, medical technology, IT and mobile communication can no longer be considered as individual disciplines. The nature of company requests for regulatory advice, in our experience, reflects the fact that we are living in an age where new ways are being discovered to treat patients that involve a combination of these disciplines. The sector is witnessing the exciting potential of making use of medical technology to deliver drugs, of diagnostics to assess drug efficacy and of rapid electronic communication to better enable healthcare staff to monitor patients and often remotely.

One way forward for many traditionally pharmaceutical companies to leverage the potential of their products is to develop products with the possibility of greater patient-friendly administration. This patient-related approach offers the potential for a huge expansion of market opportunities, ranging from those confined to hospital for their care, to those in community care and for situations where caring for patients takes place in their own homes. There is the attraction here, too, of a market driven by patient demand and supported by state policy to move care out of the hospital into the community.

The borderlines between pharmaceutical, medtech, in vitro diagnostics (IVDs), and even cosmetics, are becoming increasingly blurred and as technology advances so there are increasing regulatory challenges to be considered. Companies, both small and large, struggle with the wording and relevance of the various regulations, directives and guidance documents that exist in this area and which may, or may not, apply to their products.

Under which regulations or directives do their products fall? Who is the relevant regulator, and do other regulations or regulator have a role to play in their particular combination of products? These are just some of the regulatory questions that need to be considered.

Regulatory confusion
The lack of clarity concerning these points of regulation, combined with the technological complexities, is resulting in a growing number of companies needing help. The majority seeking advice, but not all, in our experience, regard themselves as pharmaceutical companies who are venturing into the less well known – to them – area of medical technology.

It is far from plain-sailing in this area. In the EU, in particular, more clarity is needed.

Historically, pharmaceutical and medtech have been regulated very differently: most significantly in the EU, with pharmaceutical, there is premarket approval by regulatory authorities whereas with medical technology, the manufacturer has the responsibility for signing off that their products comply with the rules, albeit usually after third-party assessment – by a notified body - of the products or the manufacture.

With the first draft proposed revision of the EU medical device directives - still due in April 2012- many are hoping for a clearer regulatory outline regarding combination products for medical device and pharma companies alike. If not, we all be on our starting blocks ready to lobby for a regulatory future that better champions the ability of healthcare product companies to realise the exciting potential of new technology for patients.

Issues still outstanding
There are many issues that need addressing.

Firstly, why is it that in the case of drug/device combination products where the primary mode of action is the medicinal product, and the pharmaceutical regulators have ultimate responsibility for assessing the product, there is no indication how the pharmaceutical authorities should fulfil their obligation to ensure that the medical device aspects of the product meet the essential requirements of the medical device directives?

And if the revision of the medical device directives deals with the regulation of combination products, and makes changes, how can these be made more accessible for companies who are accustomed to other regulatory frameworks, such as the pharmaceutical regulations?

There is also the fundamental question of whether the EU will decide to set up an EU combination product committee, or agency akin to the FDA Office of Combination Products in the US?

Even the regulatory vocabulary needs addressing. In one meeting in which our organisation was involved, where there were representatives from the pharmaceutical and medtech sectors, it took some time to realise that when the pharmaceutical people were referring to “containers” (a term used in 2001/83/EC) they were referring to what the medtech sector would consider to be drug/device combination products where the primary aim of the product is to deliver the drug.

Is it not time to aid uniform interpretation of EU rules governing combination products, to introduce a standard vocabulary?

Having these issues are addressed would represent a good start for industry. There are many different kinds of drug/device and drug/IVD combinations, which means this is a complex area to fathom. Without clear rules at the outset, it is easy to sink into the regulatory quagmire.

While it is relatively simple to explain the different drug/device combinations, it is frequently complex to assess an individual combination product and to determine the primary mode of action, especially where there are powders, creams, metals, non-pharmacological solutions and herbal products concerned.

The issues are complex, the regulatory framework disjointed. And many companies risk unnecessarily investing resources in what then turns out to be a wrong decision if they are not fully acquainted with the full regulatory picture.

There may not be a right, or a single regulatory solution to finding the regulatory path for each combination product, but what is key and astute business practice is that the company can demonstrate to the authorities that their reasoning for the choice of that regulatory path is based on sound knowledge and an informed background. If companies cannot provide a solid argument for their decision-making in this complex regulatory arena, they risk being told to redo their regulatory strategy, maybe even having to follow a long and complex different regulatory pathway, and potentially at huge cost and significant disruption for the company.

Conclusion
It is clear that the market is evolving rapidly, reflecting both technological changes and the demands from patients for better medical care. The current situation of regulatory uncertainty benefits no one and a prolongation of this state could actually be detrimental to the delivery of effective healthcare to patients. This is a year when there should be an overt push for a resolution to the issues that have been standing in the way of progress regarding borderline products.