UNNATURAL REGULATIONS

UNNATURAL REGULATIONS

Anthony Rees
(Secretary-Gerneral: TNHA)

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There is no denying that the last year was a frustrating for many stakeholders in the natural health industry, as well as for many patients and consumers who rely on these products to achieve and maintain wellness.  Each passing day we receive queries from either retailers, practitioners or health conscious consumers, asking us where they can source natural health products which are no available longer on health store of pharmacy shelves. 

Sadly, some of these products have been either scheduled and reclassified as pharmaceutical drugs (requiring a doctors prescription), or have been withdrawn from the market by nervous suppliers who await clarity on the regulatory process.

On the 15th of November 2013, and without notice, the National Department of Health (DOH) published regulations for natural health products which are now defined as ‘Complementary Medicines’.  These regulations were gazetted in terms of section 35 of the Medicines and Related Substances Act of 1965.  Section 35 delegates power to the Medicines Control Council (statutory regulator of medicines), in consultation with the Minister of Health, to publish subordinate legislation, or regulations, without the prior engagement of affected stakeholders, and without notice.

Section 35 (1)(iii) allows for new classifications of medicines into classes or categories.  As a result a new category, Category D, for Complementary Medicines was unilaterally created.

The Department of Health claims that they had consulted with the sector when they published draft Guidelines for the industry in 2011, however the TNHA and many in the industry find it spurious that after a two year hiatus, and without any dialogue, the Department of Health saw fit to go ahead and publish regulations in the gazette.

The Health Products Association of South Africa (HPA), which had a 30 year, cordial relationship with the Medicines Control Council (MCC) attempted to engage with the Department of Health since 2011, with limited success and are now engaged in a High Court action to challenge certain aspects of the regulatory process.

The TNHA are of the opinion that Act 101 of 1965 was never intended to regulate natural health products in the format they are sold today.  The natural health products market has mushroomed in the last 10 years into a R8 billion industry.

The MCCs mandate was intended to regulate the safety, quality and efficacy of novel, synthetic pharmaceutical drugs in urgent response to the potentially fatal, long term damaging and lesser side effects resulting from man-made molecules not having an established affinity with man’s physiology.  The deforming effects of Thalidomide in the late 1950’s and early 60’s was the catalyst to many countries formally regulating their medicines or drugs.

The TNHA strongly believe that the principal Act (Act 101) should have been amended first to make provision for ‘Complementary Medicines’ in a separate, appropriate regulatory framework which accounts for the philosophical paradigm in which they are intended for use and evaluated by experts in the disciplines represented.  For such a large category of products (+/- 14,000 products according to an audit process conducted by the MCC over the last decade) to be subsumed by the Act, this legislation should have been passed through the legislature (Parliament), where the public, experts in the fields of natural health and stakeholders could draw up a framework for regulation which was equitable, transparent, procedurally fair and appropriate.  Many of the abuses of power by the state we see today are the result of sidestepping the democratic process of law making, by invoking regulations.  Legislation by regulation is hugely problematic in our democratic dispensation, because the people have little or no say on how laws are written or passed.

The TNHA have concerns that pharmaceutically trained bureaucrats within the regulator have copy and pasted restrictive pieces of legislation from aboard into our regulations, which according our international alliance partners, has resulted in one of the most restrictive regulatory regimes for natural health products in the world.  We believe the regulations, once fully realised (after the four year rollout period published) will be as harmful to industry and consumers as the plethora of anti natural health Directives in the EU and Canadian regulations which have eradicated between 65% and 80% of the health products which were once available freely in those regions.

We have spoken to owners of a segment of local companies which who either actively withdrawing long established products from the market, reformulating products out of existing efficacy, or preparing to shut down or sell.  Some foreign companies who do business in south Africa have indicated their unwillingness to adapt their products to the new local regulatory requirements, and are not prepared to subject their products to the excessive research and development required to register their combination and integrative products to the level of pharmaceutical drugs. Compliance comes at a huge cost to companies, not only in terms of collating data for product registration, but also gearing up to comply with Good Manufacturing Practice (GMP) required under the regulations and guidelines.  For the majority of companies, there is no difference in setting up a lab and production facility to meet the requirements for the manufacture of dangerous toxic drugs, and natural health products. One company (name withheld) which produces probiotics is faced with a R50 million bill just to manufacture his products.

Private regulatory consultants, who assist companies to fill in their paperwork to apply for the registration of medicines are exploiting the confusion in the natural health product manufacturing sector, with many jacking up their consulting fees by as much as 1,000% since the regulations were published.  One importer of integrative products, supplied to practitioners was recently quoted R40 million to regularise their paperwork in terms of the regulations.

Natural health Products are not patentable like pharmaceutical drugs, and are financial orphans in the grand scheme of regulatory medicine. New patented drugs enjoy a twenty-five year protection from generic copies being made, allowing them to offset the tens and hundreds of millions or Rand spent on their research and development. This also allows them to make a significant profit without competition during that time.  Because natural health products are not afforded that same privilege, and are relatively inexpensive, companies are obviously reluctant to spend inordinate amounts of money on research and development, only for someone else to come along and use their research to market clone products at a fraction of the price. The regulations for natural health products do not safeguard the intellectual property of manufacturers. Theoretically anyone can access proprietary information about registered natural health products with a simple Promotion of Access to Information request.

In this introductory summary we have just scratched the surface by highlighted few issues we have identified with the regulations and the process thus far.  The regulatory process is ongoing and presents many challenges as we proceed.  Transcribing all the issues into this newsletter would require pages and pages of technical details and excessive focus from our readers.  In future newsletters we will map out the problems we have identified as the TNHA thus far and will inform you on the action we are taking in an attempt to remedy this crisis.

We will brief you on our ongoing parliamentary engagements, dialogue with regulators, intended legal action and provide feedback for industry. We encourage to to keep abreast with developments on our website or our facebook page at www.facebook.com/naturalhealthaliance.  More importantly, spread the word and forward this newsletter far and wide, or share our facebook page among your friends. If you are adversely affected by these regulations or seek advice, we would like to hear from you.

In summary these regulations are bad law and are not based on good science.  They undermine the public’s constitutional right to access natural health products, which they have freely enjoyed in their quest for health and wellness for thousands of years.  Only YOU, the manufacturers, importers, wholesalers, dispensing practitioners retailers and consumers of natural health products can stop the systematic shut down of natural medicine in South Africa.  YOU can do this by becoming a member of the TNHA and / or by sponsoring our ongoing efforts.  Even if you donate R10 towards our collective cause, it goes a long way in empowering us to help you.

If you are a consumer of natural health products, please consider buying from companies who support your health freedom by sponsoring the TNHA in the form of company exposure contained in this newsletter.  These companies have put their money where their conscience lays, and should be supported by like-minded folk.

Here is a peek into what I will be sharing in our upcoming newsletters.

• Boiling the Frig Slowly – Regulatory creep in the natural health regulations.

• Are Natural Health Products Safe? – A closer look into the ‘risks’ associated with the use of ‘complementary Medicines’.

• The Role of the Allied Health Professions Council – Are the AHPCSA pro patient or pro doctor? You decide.

• Regulations for the ‘Upper Limits’ for Vitamins and Minerals – Are the new limits capricious and unscientific, or are they a step in the right direction?