THE COMPLEMENTARY MEDICINE
REGULATIONS MUST FALL!
Anthony Rees (TNHA Chairman)
In last month’s newsletter we announced that the long awaited draft regulatory amendments for natural health products had been gazetted on the 25th of July, and that we would provide you with our official comments on them.
After reading them closely we have concluded that the Medicines Control Council (MCC) have not listened to any of the comments raised by stakeholders over the past two and a half years, and that they have again attempted to widen their net to capture the CAM sector.
Despite many warnings from the TNHA and other organizations to the MCC about their unconstitutional, unlawful and irrational conduct to date, they have forged ahead with their pharmaceutical expropriation of the natural health product sector and continue to threaten the public’s access to the majority of safe, affordable and efficacious natural health products.
LITTLE OR NO PROGRESS
In November 2013, the MCC set an ambitious five-year Road Map for the registration of natural health products. They expect applications for registration for all natural heath products to be lodged by November 2019.
We are now almost three years into this five-year registration window period and the MCC have only considered 6 (six) out of the 120 000 natural health products audited by them prior to the regulations coming into effect.
It is clear to us that the drug evaluation regime imposed on these products is incompatible with natural health products, and cannot continue without a scrapping of the current regulations.
What is needed is going back to the drawing board with an open mind and evaluating them with the health supporting paradigm with which they are formulated and used.
MCC INSIDERS SAY CAM REGULATIONS ARE IRRATIONAL AND UNLAWFUL
Over the past month the TNHA consulted with a former senior official of the MCC and a current medicines evaluator dealing with CAM applications before Council (whistle blowers names withheld). Both have serious doubts about whether the MCC has the capacity or legal jurisdiction over this sector.
Both have indicated their willingness to testify in any legal application to have the regulations repealed.
NO REGULATORY IMPACT ASSESSMENTS CONDUCTED BEFORE THE CAM REGULATIONS
On the July 20 we wrote to the MCC and requested copies of the Regulatory Impact Assessments (RIAs) which the MCC and the National Department of Health should have commissioned and published prior to the November 2013 CAM regulations.
A week later we received a response from the Registrar of Medicines, Joey Gouws, stating that the MCC had not conducted any Regulatory Impact Assessments. All of the serious legal, procedural and implementation issues we currently face can be attributed to the MCC and DoH not doing their homework prior to the drafting and passing of the regulations.
Since 2006 all National Departments and organs of state (including the MCC) have been required to conduct comprehensive RIAs for new legislation or regulations based on the input from broad-based consultation and risk assessment to identify potential stumbling blocks in their implementation and enforcement.
In May 2013, the Presidency issued a Proclamation Notice to all government departments specifying the framework in which the RIAs must be conducted. The National Department of Health and MCC have failed to adhere to this administrative imperative prior to passing the CAM regulations.
ILLEGAL IMPORTATION BLOCKADE
We have known for a while now that the Port Health Authorities, which fall under the National Department of Health, have been instructed by the Medicines Control Council not to allow any natural health products into the country without importers producing MBR 20.8 Registry Letters for them issued pursuant to the 22 February 2002 regulatory call-up notice (R.204).
The notice described complementary medicine disciplines which are not the same as those currently listed in the regulations for CAM products.
Furthermore, the MCC were only legally entitled to issue MBR 20.8 Registry Letters for six months after it was gazetted. The MCC ignored the provisions of their own notice and continued to illegally issue MBR 20.8 Registry Letters prior to the 2013 regulations. In this time period approximately 120 000 MBR 20.8 Registry Letters were issued.
Therefore, the withholding of natural health product imports by Port Health Authorities in South Africa without supportive MBR 20.8 Registry Letters is illegal.
The TNHA have called for the immediate withdrawal of this unlawful instruction to Port Health Authorities and for them to release products being held back.
On the August 30 the TNHA raised these issues with the MCC and await their official response.
ALL CAM REGULATIONS GAZETTED SINCE FEB 2002 MUST BE REPEALED
On the August 24 the TNHA officially demanded that the Feb 2002 call-up notice (R.204) be rescinded, and that all regulations for CAM products gazetted after 15 November 2013 (R. 870, R.716 and R.837) be repealed without delay. The MCC and Department of Health have been placed on notice that if they continue to unconstitutionally and unlawfully proceed in the manner they have been for the last fourteen years, they will be challenged.
Read our official call for the repeal of the CAM regulations HERE.