BOILING THE FROG SLOWLY WITH CAM REGULATORY CREEP

BOILING THE FROG SLOWLY WITH CAM REGULATORY CREEP

Complementary Medicines Regulations:  Unacceptable Regulatory Creep

Anthony Rees
(Secretary-General: TNHA)

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The ‘boiling the frog’ story is a widely-known anecdote describing a frog slowly being boiled alive. The premise is that if a frog is placed in boiling water, it will immediately react and jump out, but if it is placed in cold water that is slowly heated, it will not perceive the danger and will be slowly cooked to death.

True or not, the metaphor could not be more fitting for the regulatory regime for the natural health product sector in South Africa.  Instead of the Medicines Control Council (MCC) playing open cards in a democratic manner, and revealing the full extent of the regulations for natural health products they are aiming for, thus facing major resistance from the industry and public, they have embarked on a non-transparent process which incrementally suffocates the natural health industry and strips away the public’s constitutional right to choose the health products of their choice.

From the MCC’s phased-in approach to regulating natural health products, which began back in 2002 with what was deemed an innocuous audit under Regulatory Notice R.204, through to the latest regulations for the Safe Upper Limits for Vitamins and Minerals as ‘Health Supplements’ under Regulatory Notice R.873, we have witnessed the regulator slowly turning up the heat.  We have reached the point where manufacturers are starting to panic and the public are seeing their favorite products disappearing off the shelves.

Here is a list of bills, regulations and guidelines which have been gazetted by the Department of Health which relate to natural health products in just the last 14 months:

• Roadmap for Registration of Complementary Medicines [13 November 2013]

• Fees for the Registration of Complementary Medicines [13 November 2013]

• Quality, Safety and Efficacy Guidelines for Complementary Medicines [14 November 2013]

• Complementary Medicines Regulations (Regulatory Notice R870) [15 November 2013]

• Medicines & Related Substances Amendment Bill (Bill 6 of 2014) [26 February 2014]

• Draft Regulations Relating to the Labelling and Advertising of Foods (Regulatory Notice R.429) [29 May 2014]

• General Regulations Related to Bonusing and Sampling (Regulatory Notice R642) [22 August 2014]

• Amendment Regulations for Complementary Medicines (Regulatory Notice R.591) [15 September 2014]

• Regulations for the ‘Safe’ Upper Limits of Nutrients (Regulatory Notice R.837) [28 October 2014]

• Quality, Safety and Efficacy Guidelines for Health Supplements [14 November 2014]

From the above raft of regulatory amendments and incremental restrictions, there is no wonder the natural health sector and public have become confused, frustrated and increasingly weary.   Keeping track of all the changes in policy, and attempting to co-ordinate appropriate responses, has become the domain of a handful of experts who are either hired regulatory consultants, ex-regulators or lawyers who specialize in health policy and contracted to large drug companies.

Over the past year we have spoken to many company owners across the value chain, including raw ingredient suppliers, manufacturers, wholesalers, manufacturers and retailers, and the majority are clueless about the new regulatory environment and where they stand in it.  Many are scaling back and/or looking for new opportunities outside the natural health product sector. Some are voluntarily withdrawing well-known brands from the market, or reformulating them to the point they are no longer as effective (substituting ingredients or lowering potencies) in order to stay afloat.

A few key players have sold out to pharmaceutical companies, cashing in their chips before any enforcement begins.  All of this is BAD NEWS for the consumer, and will negatively impact public health.

As a result of this protracted regulatory roll-out scheme, there has been very little resistance to the arbitrary and capricious regulatory fervor of the regulators, and as a result the MCC keeps turning up the heat with impunity.

We are aware that in the coming months there will be further amendments to the complementary medicines regulations, accompanied by more restrictive guidelines related to controlling their safety, quality and efficacy. We have heard through regulatory insiders that new regulations are in the pipeline are for things like amino acids, essential fatty acids, probiotics and more.

The TNHA has recently raised strong objections to this regulatory creep, asking that the MCC openly declare their full regulatory plan and intended outcomes for the natural health sector.

All regulations are laws which are supposed to be a binding contract between the government and its citizens, whether corporate or individuals.  In all contracts between parties, there is supposed to be negotiation, good faith and full disclosure.

In the medicines regulatory environment in South Africa, our regulator (the MCC) sidesteps the normal legislative process through vested powers to create sub-legislation (regulations) without prior stakeholder and public engagement, or parliamentary oversight.  Section 35 of the Medicines and Related Substances Act (101 of 1965), allows the MCC to unilaterally create classes and categories of medicines, as well as regulations for their control, with only a final rubber stamp from the Minister of Health.  It does not have to engage stakeholders or elicit public response before gazetting regulations.  Since 1996, and after the promulgation of the Constitution, there has been radical law reform which curtails these autocratic tendencies by regulators. We believe it is high time to repeal of section 35 of the Medicines and Related Substances Act. Wee are currently lobbying for a more democratic, transparent and accountable regulator at the  Parliamentary Portfolio Committee on Health, as they debate the SAHPRA Bill (Bill 6 of 2014)

The TNHA is an organization that actively monitors, evaluates and timeously responds to all regulatory issues affecting Complementary Medicines, African Traditional Medicines, Functional Foods, Natural Skin Care Products and their consequences for Allied and Integrative Practitioners. More importantly we are fast becoming a consumer lobby group, standing up for consumers and patients who are the largest affected stakeholder group.

The TNHA hopes to wake up the sleepy and unsuspecting frogs which are beginning to simmer before it is too late, and lead them out of this crisis. Whether you are a consumer, practitioner or industry stakeholder, you are invited to join the TNHA so that you can get up to speed on what happening on the regulatory front and find out how you can support ours and our alliance partners’ efforts to dismantle the current regulatory system.

We call for an appropriate regulatory alternative, which is fair, transparent and based on good law and good science.