CAM REGULATIONS DERAILED

CAMS REGULATIONS DERAILED

camsregulationsderailed

Anthony Rees
(Secretary-General: TNHA)

Are natural health product suppliers still compelled to register their products as ‘Complementary Medicines’?

Many companies in the natural health product industry scrambled recently to meet the November 15 deadline to apply for registration of certain of their products deemed ‘Complementary Medicines.

These products included weight-loss products and sexual enhancement products. Many retailers have become nervous about acquiring or retaining stock of these kinds of products, fearing many may end up being illegal.

THE ROAD MAP TO NOWHERE

Section 14 of the Medicines and Related Substances Act of 1965 (Act 101 of 1965), lays out the procedures for lawful call-ups in the registration of medicines. Medicine call-ups are, without exception, published in the government gazette, and in a prescribed form.

The cover page of the ‘Road Map’ circular¹ states:

The Road Map represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive approach.

A document detailing the ‘thinking’ or opinions of a regulator is NOT a legal document, which anyone is compelled to comply with. Laws and regulations have clearly stated rules and procedures for compliance, and cannot be vague.

The ‘Road Map’ circular was NOT published as a call-up notice as prescribed by law (in the Government Gazette), and has NO force and effect, as the Medicines Control Council would have the industry believe.

BILL 6 OF 2014 NO LONGER DEFINES COMPLEMENTARY MEDICINES

Parliament has assented to the Medicines & Related Substances Amendment Bill (Bill 6 of 2014). All that is left now is for President Zuma to sign it into law, and to provide a date for its commencement.

Since their publication the TNHA and various legal experts have held the opinion that the ‘Complementary Medicines’ regulations are ultra-vires*, meaning they have no proper authority in law.

ULTRA VIRES: – beyond the scope or in excess of legal power or authority – Black’s Legal Dictionary

Without an enabling clause in the principal Act expressly defining ‘Complementary Medicines’, they are simply not covered by the Act or its subordinate regulations.

When the ‘Complementary Medicines’ regulations² were gazetted there was no explicit enabling clause in the principal Act (Act 101 of 1965) which defined ‘Complementary Medicines’ separately from pharmaceutical drugs, therefore they are not included.

Timeline Summary:

22 February 2002: Medicines Control Council published Regulatory Notice R204 in the Government Gazette to understand the number and variety of ‘Complementary Medicines,’ sold on the market at that time. Although it was valid for only 6 months, companies submitted more than 20,000 products’ information up until 2012.

15 November 2013: Complementary Medicines Regulations 2 gazetted. Contained no Road Map. Includes a definition of Complementary Medicines.

February 2014: Johannesburg and Cape Town: Road Map 1 circular issued by Medicines Control Council (MCC) and ‘Calling for medicines’ deadlines set and presented during workshops by Dr. Kaizer Thembo of the Complementary Medicines Unit of the MCC.

15 September 2014: Regulatory Amendments³ published. No Road Map. No definition of Complementary Medicines.

THE ORIGINS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT

The 50-year-old Medicines and Related Substances Control Act⁴ was originally intended to control pharmaceutical drugs after a proliferation of high risk new-to-man drugs were sold in the Republic, without safeguards to protect the public from their potential harm (eg. Thalidomide and phenacetin).

The Act was originally fit for purpose when it came into being. Yet it, and the regulator it created, are now ineffective in preventing adverse drug reactions from pharmaceutical drugs becoming a leading cause of death.

The Act and its regulations are wholly inappropriate for the regulation of safe, low risk natural health products, which are not ‘medicines’ (pharmaceutical drugs) as originally defined. On a scale of risk and mode of action, natural health products are more food-like than drug-like. In fact, they pose a statistically lower societal and individual risk than common foodstuffs.

In 1994, the Food and Drug Administration in the United States passed the Dietary Supplement Health and Education Act for all natural health products, regulating them as a special category of foods in view of their GRAS (Generally Regarded As Safe) status. Our regulator views natural health products as quasi drugs, which are deemed unsafe until proven safe.

This places a costly and unnecessary burden on manufacturers to prove the contrary, and threatens the survival of small and medium sized companies and retailers. The real losers will be the public, who will lose access to many safe, effective and affordable natural health products.

In late 2013, the National Department of Health appeared to have recognised their lack of explicit jurisdiction over ‘Complementary Medicines’ under Act 101, so they proceeded to insert a new definition for ‘Complementary Medicine’ in Section 1 of Bill 6. To patch up their mistake, so to speak.

From the beginning the TNHA vigorously opposed the inclusion of the definition of ‘Complementary Medicines’ in Bill 6, in the absence of a definition for African Traditional Medicines, when appearing before the Parliamentary Portfolio Committee for Health. The TNHA contends that separate development legislation, which discriminates on ethnic, cultural and traditional grounds, is discriminatory in terms Section 9 of the Bill of Rights in our Constitution.

At the hearings the TNHA : –

demanded that Bill 6 regulate ALL forms of traditional medicine (indigenous and non-indigenous) on a level playing field, and in an appropriate risk-based manner, or both be excluded in their entirety.

called for an independent regulator, separate from the Medicines Control Council, to assess and regulate traditional and natural health products.

The ‘Complementary Medicine’ definition in Section 1 of Bill 6 was subsequently removed from Bill 6 by Parliament during the law-making process. The final version of Bill 6 [B6D-2014]⁶ confirms this deletion.

NATURAL HEALTH PRODUCTS MUST BE REGULATED SEPARATELY FROM DRUGS, OR NOT AT ALL

Our legal counsel advises that the removal of the definition of ‘Complementary Medicine’ from the operation of the intended Act is a fundamental shift in policy on behalf of the legislature, demonstrating its intent NOT to include natural health products under the jurisdiction of the South African Health Products Regulatory Authority (SAHPRA).

Given the context of the discussions before the Parliamentary Committee, no other interpretation is possible, except that Parliament agrees with us and not with the Department of Health that Complementary Medicine must be regulated separately from drugs or not at all.

Parliament has decisively rejected the approach of the Department over the last few years and the Department must now change its approach.

The TNHA calls on the Department of Health to repeal its existing ultra vires regulations for ‘Complementary Medicines’, and to halt all further regulatory amendments in light of these instructions from Parliament.

Parliament has decisively rejected the approach of the Department over the last few years and the Department must now change its approach.

TO APPLY FOR REGISTRATION, IS TO VOLUNTARILY DECLARE YOUR PRODUCTS ‘MEDICINES’ UNDER THE ACT.

If your company wishes to comply with the ‘Road Map’ circular, and proceed to apply for registration for any of your natural health products as ‘Complementary Medicines’, you willfully submit to being regulated in the same way as a pharmaceutical manufacturer.

You further concede that you are selling ‘medicines’ as defined in Section 1 of the Medicines and Related Substances Act.

This includes those who submitted applications for products in terms of the 15 May 2013 ‘Road Map’ deadline for the registration of anti-viral agents, oral hypoglycemics (for diabetes), cardiac medicines or cytostatic agents (for cancer). You have the lawful right to withdraw any existing applications, based on your knowledge of the regulations being ultra-vires and the ‘Road Map’ circular being unlawful.

The MCC contends that a medicine … is a medicine … is a medicine, no matter what its origin,

tradition of origin or composition. We believe this interpretation should be declared void for vagueness and for a violation of various constitutional rights. The definition of a medicine is overly broad.

For example, water and oxygen are considered medicines if they are recommended for dehydration or for sustaining life, respectively. Substances which should be declared medicines such as tobacco, caffeine and alcohol are spuriously exempted.

THE REGULATORY TRAP

During April 2014 the then Registrar of the Medicines Control Council, Ms Mandisa Hela made a presentation titled ‘Complementary Medicines Challenge,’ which appears to have been delivered to the American Association of Pharmaceutical Scientists (AAPS).

In her slide presentation she credited Mr Rene Doms, past Head of the Department of Health’s Inspectorate and current co-ordinator of the Regulatory Discussion Group (RDG) citing a document titled “Doms R; 2014: Plan to clean up the complementary medicines industry in South Africa.” In her closing slide she included Doms’ graphic depiction of the fate for which most natural health product companies were destined to endure under the Nov 2013 regulations (below).

trainleft

As the Road Map circular is invalid, the regulations for Complementary Medicines are ultra vires and the definition for Complementary Medicines is gone from Bill 6, the regulatory train has derailed.

DO THE ‘REGISTRY NUMBERS’ RECEIVED FOR PRODUCTS SUBMITTED IN TERMS OF THE FEB 2002 ‘CALL-UP’ NOTICE COMPEL COMPANIES TO REGISTER THESE PRODUCTS?

On 22 February 2002, the Medicines Control Council published Regulatory Notice R204 in the

Government Gazette in order to gain an understanding of the number and variety of ‘Complementary Medicines,’ which were sold on the market at that time.

Although the notice was valid for six months after its publication, companies continued to submit their product information up until 2012. More than 20 000 products were listed. Over these ten years, the files were left strewn in the corridors of the Medicines Control Council to gather dust, with no further action.

Photo: The massive pile of CAM notifications lining the corridors of the MCC in 2009. Taken by Dr Nicholas Crisp – Nov 2009 for his DoH commissioned project titled “A GLIMPSE OF WHAT SAHPRA IS INTENDED TO BECOME”

Since the 2002 notice, importers, manufacturers, wholesalers, retailers and consumers have been unsure about the legal status of these products.

Companies which submitted applications had an expectation that these submissions served as the first steps in gaining registration, rather than simple notifications in an audit exercise.

IT WAS A SIMPLE AUDIT EXERCISE

Ms. Mandisa Hela, the Registrar of Medicines in 2013, who penned the Road Map circular, wrote this in the open remarks of the circular (pg. 3):

On 22 February 2002 the Council published a notice in Government Gazette No. 7282, R.204 solely for the purpose of an audit of products already on or about to enter the market at that time ..

Judge Zondi in his 2008 judgment⁵ on Matthias Rath and others – including the Chairperson and Registrar of the MCC – stated that the 2002 call up notice was ‘inelegantly worded’ and ‘contradictory in terms’.⁵ In essence he declared the 2002 call up notice null and void.

Any stamped letter with a ‘registry number,’ which companies received after submitting their products in terms of the 2002 notice, are now worthless pieces of paper. Companies are therefore not compelled to adhere to the current regulations or ‘Road Map’ circular by virtue of having complied with the 2002 notice.

WHAT HAPPENS IF THE MCC TRIES TO FORCE YOU TO REGISTER YOUR PRODUCTS?

If your company or practice is a TNHA member and is targeted by the Department of Health’s Law Enforcement Unit and/or Inspectorate, please contact the TNHA immediately.

Any unlawful and unconstitutional attempts by the Medicines Control Council of SAHPRA to enforce the Nov 2013 regulations for Complementary Medicines, or attempt to enforce registration deadlines stipulated in the Road Map circular, will be vigorously opposed.

We have a legal team who is up to date on these issues and ready to support our members.

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