Natural Health Products: Challenges and Opportunities in the UK (Article)

Introduction
It is true that currently there are many challenges being faced by the natural health products industry not only in the UK but also the world over. There are, however, many opportunities too which shouldn’t be ignored.

The words “natural”, “herbal” and “plant derived” can be misleading and it is important for the consumer to be reminded that such products are often medicines in their own right. Health Authorities have been concerned about the safety profile and quality of such medicines for a number of years.

The laws applicable to, for example, herbal preparations varied across Europe and therefore, the EU Directive 2004/24/EC was implemented in order to harmonise the regulations, enable the free movement of herbal products within Europe and protect the consumer.

Your natural product, however, may not meet the criteria of an herbal remedy or medicinal product. So what are the other routes onto the UK market?

Biocidal Products Directive
Cosmetic
Food
Food with Health Claim
Food Supplement
Medical Device
Medical Food
Novel Food
Orphan Drug
PARNUTS (foods for Particular Nutritional Uses)
Well Established Use

All of the above are applicable to Europe.

The Advisory Committee on Borderline Substances(ACBS) is another possibility and is unique to the UK. It is the committee responsible for advising approved prescribers on the prescribing of certain foodstuffs and toiletries such as enteral feeds and foods that are specially formulated for people with medical conditions but also include some toiletries, such as sun blocks for use by people with conditions such as photodermatosis.

It is known to be hard to get approval with good clinical trial data being essential for a successful submission. The key advantage, however, is a listing under the “Borderline Substances” section in the UK’s Drug Tariff (a monthly publication used as a reference for the payment and repayment of NHS prescription costs by pharmacists or doctors dispensing in Primary Care).

Opportunities in the UK
Unlike countries such as France and Germany, the natural product industry in the UK is still relatively young which means the market is far from saturated. In fact, within the last few days, BBC Breakfast News announced that 1 in 4 people in the UK now use natural products. These numbers are increasing for several reasons:

an ageing population taking preventative measures to avoid ill health.
retirees with money to invest in their health.
‘natural’ is perceived to be ‘healthy’ and ‘safe’.
the financial crisis is encouraging the consumer to adopt healthier lifestyles to prevent illness.
via the internet and social media there is a wealth of data so the consumer has the ability to make more informed choices (as opposed to relying solely on the recommendation of their doctor or consultant).
conventional UK clinicians aremore amenable to discussing and recommending the use of natural products with their patients because regulations are improving quality and safety profiles.
the NHS is undergoing significant reform with more emphasis on preventative healthcare within the Primary Care setting so as to avoid costly hospital referrals and admissions.
it is believed that many UK herbal companies will cease trading with effect from 1^st May 2011 resulting in a gap in the marketplace. Companies who have the necessary financial backing can take advantage of this situation.

Action Plan
For any company wishing to enter the UK natural products market, it is vital that they plan and understand their registration strategy. Global Regulatory Services (GRS) is currently advising numerous non-UK clients on their strategy by reviewing the following product information:

ingredients (actives and excipients)
composition (quantities + presentation e.g. capsule)
confirmation of how the products are used/consumed
a list of all the claims which, ideally, the company would like to make (along with some alternatives) and any supporting evidence which may support these claims
packaging, labels, leaflets and other marketing material
study/clinical trial data

From this GRS can determine and advise on the best route to market. Of course, commercial considerations must also be taken into account e.g. quickest and cheapest route to market or longer timescales resulting in a potentially more robust product.

Once the registration strategy has been agreed, GRS can either take on the submission process in its entirety or be on hand to advise and guide the client through the process. GRS has the advantage of a good working relationship with the regulatory bodies which very often speeds up turnaround times. Wherever possible we maximise these relationships to the benefit of our clients.

The Future
2011 is going to be an interesting and challenging time: the regulations are currently in a state of flux particularly those relating to foodstuffs with the conclusion of several consultations to be released during the year. In addition, the impact of the EU Directive 2004/24/EC relating to herbal remedies is yet to be understood.

Unfortunately, there are no guarantees as to whether a company’s chosen registration route will be approved. With a good package of supporting data and evidence, however, the chances of success are maximised.

One key message to remember is that with so many of the regulations being amended and updated, it is vital that companies maintain their awareness of possible and actual changes which could affect the positioning of their product(s). As a ‘value add’ GRS maintains a watchful eye on behalf of their clients.

Author: Greer Deal, Director of Global Regulatory Services