Building regulations for product safety, regulation and classification

Farzad Henareh, Stericycle ExpertSolutions, discusses taking responsibility for product safety, regulation and classification

In today’s complex regulatory environment, product classification, particularly in the medical and health sectors, is an important component of product safety. Varying regulations govern different product categories, whether they are pharmaceutical, medical devices and instruments or even health applications on mobile and tablet devices.

One of the difficulties is ensuring that all parts of the supply chain, from manufacturers and developers to distributors and retailers understand and comply with regulations; another is how regulations differ from country to country, not just in Europe but across the world.  All stakeholders, including regulators, must take ownership of product safety. To shirk this responsibility leads to confusion at best and a dangerous threat to consumer’s health at worst.

It is not unusual to see pharmaceutical or medical device companies recalling products for a range of reasons. Recently the Medicines and Healthcare products Regulatory Agency (MHRA) initiated the use of unique device identifiers based on GS1 standards to improve traceability, efficiency and the onerous financial impact on the NHS in the event of a healthcare recall. However, collectively the aim should be to prevent recalls and to do this we need to more carefully scrutinise and police regulations and combat the discrepancies in product classification.

 At Stericycle ExpertSolutions we publish a quarterly European Recall and Notification Index which for Q2 2015 shows that there has been a 7% drop in the number of recalls in all sectors by comparison with Q1. This suggests that manufacturers are increasingly taking responsibility for ensuring and improving safety standards. However, in the broader context it is apparent that since 2003 safety notifications and recalls have actually been on an upward trend, and 88% of them have been classified in the most ‘serious threat’ category.

The pharmaceutical picture

The global pharmaceutical industry could be worth nearly $1.6 trillion by 2020 says PriceWaterhouseCoopers, but it has warned that new entrants to the market and new technology are beginning to disrupt the status quo. Amongs the threats are counterfeit medicines which are prompting increased traceability programmes to try and curb the hazards they present.

Like in so many sectors, the challenge for pharma companies is that the industry has no single regulatory enforcement agency, which means that organisations are battling not only to implement traceability procedures, but also to meet the standard product safety rules. One light on the horizon is a willingness in Europe by central governments to work together to adopt traceability regulations and implement legislation.

Health apps

Away from pharmaceuticals – but still in the wellness sphere – another example of regulatory confusion can be found in the smartphone health and medical applications sector. According to a recent report from the Deloitte Centre for Health Solutions, there are currently over 100,000 medical apps available in the UK app store. Where these remind consumers to take critical medication or monitor life-threatening conditions, they can revolutionise people’s approach to health and wellness. However, developers must be aware of the regulations governing them. Once again, the MHRA, together with the European Commission, have issued guidance on whether a healthcare app can be considered a medical device based on a list of keywords. Apps that are intended to ‘diagnose’ or ‘monitor’ fall under the medical device category and all the safety implications that it carries, while those that remind patients of medical appointments are considered to be consumer applications. Imagine the potential for confusion and the health safety issues, if apps don’t fit neatly into these two categories. Inevitably, the impact of incorrect classification will have an effect on the notification and recall landscape. For example, the industry may start to see programme errors in a health and wellness app being classified as a medical device recall event.

The government is currently reviewing the UK’s system for the recall of unsafe products under consumer champion, Lynn Faulds Wood, and the classification and regulation issues are sure to be high on the agenda. In the meantime our evolving pharma and medical device environments with their complexity of regulations demands that all of us have to remain vigilant in order remain safe.