HPA/CAMS HISTORY AND BACKGROUND

HISTORY AND BACKGROUND TO HPA/CAMS IN SOUTH AFRICA
There has been a long process of setting up a world class control system for Complementary and Traditional Medicines in South Africa – this now needs to be implemented.

1985  
•    The Minister of Health declares homeopathic medicine to be both ineffective and dangerous. (All in 1 year) and wants to remove them from the market
•    Homeopathic Industry needed a valid response which resulted in the 1986 visit to Europe and USA re : control on homeopathic medicines
•    Result – it was noted that;
–    No system is consistent
–    No system is rational
1987
•    Constitution of the first MCC Homeopathic committee was put in place
–    To appropriately address regulation of Homeopathic medicines in SA
–    It consisted of a Homeopathic Practitioner, Medical Doctor, a Lawyer and a Person from Industry.
•    It was realized that appropriate Safety, Quality and Efficacy controls were relevant and needed to be implemented.
•    All of this ended in a rational proposal in the so called “pink list” with the  acceptable;
–    List of substances
–    List of indications

Early 1990s
•    The MCC Homeopathic Committee was then converted into a Complementary Medicines Committee as the same principles could be applied to all the other “paradigms” of Complementary Medicines

1996
•    Several Broad Stakeholder Meeting were held with the then Director General of the DOH which resulted in:
–    Appointment of a new “wider” CMC that addressed ALL “paradigms” of CAM’s.
–    The beginnings of wide stakeholder involvement through the formation of the “Broad based reference groups” (BBRG’s) representing and giving input for each of CAM’s paradigms.
•    It was recognized that CAM’s were different to Orthodox medicines and:
–    That access to and wide availability of was needed for CAM’s in South Africa
–    The beginnings of an electronic lodgment system was developed which was based on the then TGA system (this was known as the “Listing Procedure”).
*  This system made assessment according to pre-determined lists of substances and indications.
*   It also provided for a quick and easy system to follow.
*   It was accepted by both MCC and Industry at large
1997                                                                                                                                                                           .
•    In February of 1997, the then Registrar of Medicines, Prof Johann Schlebusch, after extensive engagement with the HPA, was ready to implement regulations which incorporated the listing system, a schedule of approved and safe ingredients, appropriate levels, indications and permissible claims.
•    Transformational changes within the DOH saw a review of management and most of the people involved in this process were replaced. The system was shelved.
1998
•    The SAAMDRA ACT was published
–    4 Boards were provided for, one of which was for CAM’s
–    The full lists of substances and indications were approved by the MCC for all CAM’s paradigms
–    A grading system was developed in place of scheduling (G0, G1, G2 and G3)
–    Provision was made for the first a quick “listing procedure” and a “longer application procedure” as well.
•    Prior to it’s implementation the CAM’s listing system was presented to and accepted by wide interest groups including:
–    MCC
–    ANC Health Study Group
–    Parliamentary Portfolio Committee
•    The SAMMDRA ACT, which was signed into law by president Nelson Mandela, was repealed as there were no accompanying regulations, and did not go into operation
•    There were many new persons in the MCC secretariat as well as new MCC members
•    This resulted in the “Total System” having to be re-worked and all the new persons having to be convinced of its merits.

1998-2002
•    Work was “re-hashed”
•    CMC was disbanded and the MCC working group was formed
•    Various draft versions for the Act and regulations were written to include CAM’s

2002 – 2003
•    Peter Kreft was engaged as a consultant to the Registrar
*  Comprehensive document was completed which included all assumptions and past work.
*  Proposed changes to Act 101 and Regulations
*  Reproducible and rational methods for handling of grading, all other technical aspects and ADR’s
*  Guidelines were drawn up.  They included appropriate guidelines for each class of CAM’s.
* “Listing Software” with a web interface was written
•    On the 22nd of February 2002 a call-up was published which resulted in Industry adopting an informal approach to the listing system taking into consideration of the acceptable lists of substances and indications with associated wording.
•    The Registrar was informed that the Parliamentary load for 2003 & 2004 was too heavy and that changes to Act 101 would not be possible.
•    Industry was given a 6 month window in which to submit applications “as a first step to Registration”.

2004
•    The Registrar immediately explored implementing control for CAM’s via the Regulations to Act 101
•    The Minister of Health was under pressure from many groups to control the “irresponsible” aspects of CAM’s
•    Regulations were published for comment without much discussion
•    These regulations were totally different to those that had been agreed upon in principle since 1987
•    These regulations were never promulgated
•    Industry continued with the 2002 call-up process including the use of the accepted claims and substances with associated wording as per the listing system
•    Lists were further developed and updated by Industry, the HPA and MCC
•    The MCC continues to accept the 2002 call-up submissions
•    Many meeting took place between DOH and Industry

2005 – 2007
•    Industry continued with the 2002 call-up process including the use of the accepted claims and substances with associated wording as per the listing system
•    The MCC continues to accept the 2002 call-up submissions
•    Several meetings took place between the DOH and Industry

2008
•    Regulations were published again that incorporated a separate Category D for CAMS with a proposed fast track registration system
•    These regulations were commented on by Industry by were never promulgated
•    Industry continued with the 2002 call-up process including the use of the accepted claims and substances with associated wording as per the listing system
•    Lists were further developed and updated by Industry
•    The HPA starts their own self-monitoring committee to ensure compliance
•    Many meetings took place between DOH and Industry

2009 – 2010
•    Industry continued with the 2002 call-up process including the use of the accepted claims and substances with associated wording
•    The MCC passes a resolution to rescind the 2002 call-up.
•    The HPA lodges an appeal against this decision.
•    The appeal is never heard and a negotiated settlement reached.
•    The MCC continues to accept the 2002 call-up submissions, but adopts a more intense review of each application during 2010, this was welcomed by Industry
•    Several meetings took place between the DOH and Industry

2011
•    Regulations were published again, these incorporated a separate Category D for CAMS but did not incorporate the listing system
•    These regulations were commented on by Industry by were never promulgated
•    The MCC continued with a more intense review process as per the 2002 call-up
•    Several meetings took place between DOH and Industry
•    Cabinet approved the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a schedule 3A public entity. This body will regulate all medicines (including separate pillars for complementary medicines and African traditional medicines) and medical devices as well as foodstuffs and cosmetics with medical components and will replace the Medicines Control Council.

2012
•    The announcement of the South African Health Products Regulatory Agency (SAHPRA) target date of implementation delayed again to 01 April 2013.
•    The MCC / DOH continues with their intense review process of 2002 call-up but towards the middle of 2012 the “rules” seem to change with submitted dossiers being rejected based on previous allopathic medicine call up notices
•    Several meetings took place between DOH and Industry

2013
•    South African Health Products Regulatory Agency (SAHPRA) target date of implementation delayed yet again – no dates given.
•    Up to and including October 2013, the MCC / DOH continues with their intense review process of 2002 call-up
•    Several meetings took place between DOH and Industry
•    November 15th  – Regulations and Guidelines are published. Guidelines published
•    Panic sets in. Meetings with lawyers and consultants abound. Serious concerns raised about the survival of the CAMS industry and the impact on the economy.

2014
•    Panic escalates. More and more meetings are held with consultants and senior council.
•    February: MCC/DOH workshops are held causing more confusion and concern
•    March 10th; Meeting planned between the HPA & Registrar becomes a meeting with the CMC and some delegates from the DOH/MCC. Constructive and all in agreement that we have a mess on our hands and have to find a mutually acceptable way forward.
•    The CMC undertakes to address our unanswered questions in writing and the HPA undertakes to submit some proposals. The HPA has done so. And awaits a response from the CMC/DOH.
•    Having exhausted all avenues of attempts to engage with the regulators, papers are served on the Minister on 14th May (before our window of opportunity to challenge the regulations expires on the 15th May)
•    May 15th: The registrar meets with HPA delegates. Suggests the formation of an ITG to address problems.
•    June 11th: Still no answers to the questions posed to the CMC after the meeting of 10th March. No minutes of the meeting received to date.
•    No responses from the Minister or Registrar to our requests to meet urgently.
•    Radio silence.
•    Amended regulations published on the 14th of September for comment along with Guidelines and a Roadmap.
•    The HPA suspends litigation to facilitate engagement.

2015
•    Comprehensive comments submitted. No feedback received.
•    Formation of the CWF [CAMs Working Forum] to engage with the Registrar.
•    Constructive meetings held. Registrar advises that the Roadmap is not working.
•    Registrar requests industry to use the existing ITG as the interface of engagement.
•    Specialist CAMS Committee formed [not fully representative of stakeholders – DSA and TNHA excluded]
•    CWF disbanded.
•    Internal and external ITG meetings held (0ne attended by Prof Helen Rees MCC Chair)
•    Industry advised that regulations are to be published (probably in October)
•    The Roadmap is to be unchanged.
•    Workshops on CTD for CAMs hosted by the NDoH and welcomed.
•    GMP and Licensing workshop for CAMs scheduled for September.
•    Confusion and uncertainty still prevails.
•    Increasing evidence that the industry is going underground.

2016
•    Internal and External ITG meetings continue with the regulators and other associations gaining a better insight into the CAMS industry and the problems. Progress is made.
•    CTD format, RP, stability and licensing issues still on the table and unresolved. The costs of compliance a major obstacle to smaller companies unable to afford these costs and survive.
•    Workshops are held by the HPA and other associations in the above regard.
•    It becomes increasingly apparent that CAMS do not fit well into an allopathic paradigm.
•    Further draft regulations published in mid-2016. Comments are submitted.
•    Some registration applications are made. Six products achieve “right of Sale”.
•    No CAMS products are registered.
•    Importers face problems at Port Health. Only MB 20.8 documents are accepted for product entry. No new products allowed without prior registration.
•    Similarly, local marketers cannot legally launch new products without full registration. The industry in stifled. More CAMS companies go underground.
•    The promised amended regulations prior to year-end are not forthcoming.

2017
•    Amended Regulations are published for comment (3 month period) in January 2017.
•    The Call-up/in of 2002 is rescinded causing further confusion (e.g. the status of the MB 20,8 document)
•    Workshops on GMP and stability are hosted by the HPA in Johannesburg and Cape Town – well attended.
•    Deadline for comments on the January 2017 draft regulations – April 27th 2017.

Updated April 2017

HOW TO BECOME A MEMBER

To experience the many advantages of being an HPA member, simply click on the button below.

DOWNLOAD FORMS

SIGN-UP FOR UPDATES

Get all the latest news and our exclusive content straight to your email inbox.

0b9f88853b3eb24a594d173a266d8de8{{{{{{{{{{{