Chairman’s Report – July 2017
It is with great sadness that we heard of the recent death of Greg Anderson who served on our Executive Council for many years. He made a significant contribution to the HPA; particularly in working with Howard Snoyman in having our CAMS marketing code incorporated into the MCA Code. Greg was killed while cycling, a sport which he loved and at which he excelled. Our condolences to his family and friends. The HPA will be contributing to his family’s charity of choice.
An overview of Technical and Regulatory Developments:
This AGM is a milestone for me as it will mark the last day of my tenure as Chairman of the HPA. Having served on the Executive Council for 32 years, (as Treasurer and Vice Chairman) and as Chairman for 4 years, a great deal of turbulent water has passed under the HPA bridge. It’s been a bumpy ride. I have decided that it’s a good time to hang up my gloves, step down and make way for new, younger leadership. The HPA has a very strong Exco, President and Secretary. I have total confidence that they will actively pursue our stated objectives of promoting and protecting our industry and our members. Based on current evidence, it may well be that the quest for an appropriate and workable legislative and regulatory regime is not yet over.
My position as Chairman started with the publication of the November 2013 CAMs Regulations which, as you are acutely aware, were inappropriate, unacceptable and unnecessarily destructive to the CAMS industry and the economy. New products could neither be launched or imported without prior registration. The CAMS industry was stifled and innovation blocked.
Then followed a concatenation of events:
• The HPA had a 6-month window of opportunity to legally challenge the regulations
• Despite our every effort, the regulators were not willing to engage – Papers were served on the Minister and DoH in May 2014 after extensive consultation with our legal advisors.
• The DoH breaks off all communication with the HPA
• Ethicore is appointed to advise on political strategy.
• The HPA agrees to suspend litigation provided that meaningful engagement takes place.
• A CAMS Working Forum is established comprising all major CAMS stakeholders.
• Good progress is made.
• The Registrar then decides that the interface of engagement should be via the established Industry Task Group [ITG]
• The CWF is abandoned and a CAMS Working Group ITG sub-committee is formed.
• Wayne Robinson is appointed as HPA Director of Technical and Regulatory Affairs.
• Progress is made but, to date, no CAMS products have been registered as per the stipulated Road Map in the 2013 Regulations
• Draft Regulations and Guidelines are published in September 2014 and July 2015 to which the HPA makes comprehensive comment.
• In July 2016, amendments to the consolidated General Regulations supporting the Medicines Act as amended by Act 72 of 2008 were published. The concept of a Health Supplement was also introduced and a definition was included. A comment period was allowed and 40 submissions were received.
• Final publication was to have been in September 2016, then December 2016, then April 2017, then June 2017 and then 21 July 2017. Regulation are still awaited.
• In February 2017, the call-up of 2002 was rescinded thereby causing confusion and nullifying the status of the MB20.8 document which only the Port Health authorities continues to recognise; albeit inconsistently and to the detriment, in particular, of CAMS importers.
• Bill 6 (the Medicines Act 14 of 2015) was finally signed into law on the 1st of June 2017 enabling the MCC to be replaced by SAHPRA (the South African Health Products Regulatory Authority). However, in order for SAHPRA to become functional, the SAHPRA Board has to be constituted and a CEO appointed – an event which is yet to take place.
The HPA has been consistent, over the past 30 years, in requesting that CAMS should have its own Directorate and Registrar with separate and appropriate regulations (as was contemplated in the SAMDRA Act of 1998). Sadly, this Act was repealed early in 2002. It now appears that CAMS are to be subsumed into an allopathic paradigm – this despite our interaction with the ITG, other Government Departments and a presentation to the Parliamentary Portfolio Committee on Health [PPC]. The consequence of this is an onerous and expensive registration procedure with prohibitively high costs of compliance. Licensing and GMP requirements remain problematic. Hopefully amended regulations, when published, will recognise that these constraints are to the detriment of the regulators, the industry, the economy and the consumer.
Sadly, I would have to acknowledge that after over 30 years of actively seeking appropriate CAMS regulations and taking legal action, the HPA has not yet achieved a workable outcome. What was achieved was an acceptance by the regulators that the 2013 regulations which, at this point in time remain law, had to be revisited. I guess our legal action bought a reprieve which allowed us to continue trading for 4 years. The law has not been actively enforced. All is not lost and we remain open for business.
We also succeeded in resurrecting an ongoing engagement across a broad front which has yielded some positive results and a recognition by the DOH/MCC and PPC that the HPA is a responsible organisation which does indeed seek regulation which is risk related and appropriate. They have a better understanding of our position and appear to be taking cognizance of our comments. I believe that the perception that the HPA is averse to being regulated has been dispelled.
Publicity and Promotion:
The stated mandate of the HPA and its Executive Council is to protect and promote our industry. Of necessity, we have been largely preoccupied in the protection aspects of legislation and appropriate regulations. However, promotion has not been neglected and the HPA has undergone a complete “face lift”. A new logo has been created and a comprehensive website launched. This contributes to enhanced membership benefits. Our Public Relations agents have given the HPA extensive exposure.
Our relationships with the media, other associations and stakeholders has been greatly enhanced.
We continue to interact with IADSA who assist us and provide valuable input in terms of global best practice. Our president, Bruce Dennison, attends the AGM and maintains close liaison with IADSA. Simon Pettman and Cynthia Rousselot have visited us and met with the Registrar and Chairman of the CMC. Cynthia will be making a presentation at the forthcoming workshop in Gauteng. Neil Gower has undertaken to address the content of the imminent General Regulations at both the Johannesburg and the Cape Town HPA workshops.
ASA and MCA:
Having severed links with the ASA, the HPA has entered into an agreement with the Marketing Code Authority which binds our members to joining the MCA and to compliance with their code which now incorporates CAMS. The MCA confines its jurisdiction to health products and medicines and has wellestablished mechanisms in dealing with advertising/marketing complaints. A commitment to the MCA is a good credential for the HPA and is an undertaking by our members that they will advertise and market their products in a responsible and honest manner; i.e. synonymous with our HPA code of conduct. In addition, our internal Self-monitoring and Advisory Committee [SMAC] continues to serve and assist our members.
The HPA’s financial position remains strong. The Annual Financial Statements for the year ending in December 2016 will be tabled for adoption.
Whilst we cannot anticipate the content of the forthcoming General Regulations, our quest for a degree of independence may well be ongoing.
Having achieved recognition and established our credentials as the major association representing the CAMS industry, we have the ear of the Regulators who have acknowledged that the Regulations of 2013 are unworkable. I believe that they now have a better understanding of the complexity and diversity of our industry and will take cognisance of our position going forward.
I have no doubt that the HPA will grow in stature and will continue to work in a spirit of cooperation with the regulators in the pursuit of a mutually acceptable legislative and regulatory environment for CAMS.
The HPA has a strong membership base and a capable Exco, well equipped to deal with any future challenges.
My tenure as Chairman of the HPA has been an interesting time. It has been a pleasure and a privilege to work with a dedicated and competent Executive Council. I could not possibly have managed to lead the HPA without the fantastic support of our members, the Exco, our President, Bruce Dennison, Janet Welham, Wayne Robinson, IADSA and Deirdre Allen who has been a pillar of strength, help and encouragement.
Words cannot adequately express my thanks and appreciation to all of you.
I have been persuaded that, if re-elected to the Exco at our AGM, I should continue in the role of Treasurer. I would be honoured to further serve the HPA and its objectives.
Best wishes for the forthcoming year.