TNHA REFUSES TO JOIN PHARMACEUTICAL INDUSTRY SECTOR BARGAINING GROUP
Just over a month ago the CAMS Working Forum (CWF), of which the TNHA has been a member since its inception, met with Ms Joey Gouws, the Registrar of Medicines of the Medicines Control Council (MCC). This was the second meeting which she has afforded the CAMS industry since the Health Products Association (HPA) launched its Gauteng High Court action in May 2014. After the HPA suspended its court case, and after sustained pressure brought to bear on the MCC by the TNHA and HPA, it appeared that the MCC were at last prepared to engage stakeholders. In February this year members of Parliament’s Portfolio Committee on Health chastised the MCC and Department of Health for their lack of engagement with stakeholders after the TNHA’s oral and written submission made to the Committee, complaining of their lack of transparency and just administrative action.
We had hoped that the meeting between the CWF and Gouws have would opened up sincere communication channels between the largest stakeholder group (CWF) and the regulator, after almost a year of being stone-walled. We had hoped that these engagements would have afforded us the opportunity to air our concerns about the current regulatory framework for natural health products, which has practically failed.
At this meeting Gouws admitted that the MCC had only received 15 applications for natural health products since the first call-up for registration of certain indicated products in May 2014, more than a year ago. This group of products included antiviral agents, oral hypoglycaemics (for diabetes), cardiac medicines (for heart conditions) and cytostatic (for cancer) agents. According to Gouws the assessment of these products has not yet been completed.
The TNHA believes it will be impossible for the MCC to register more than 14 000 natural health products in the next three and half years which companies have been given to submit their products for registration, when they have been unable to complete just 15 submissions. Is this just incapacity, or is it a strategy to prevent the required registration of natural medicines? It is common knowledge that there are already serious backlogs of pharmaceutical medicines awaiting registration of between three and five years, despite the MCC piloting expedited e-CTD applications (electronically) for the last four years.
Between 2002 and 2013, the MCC conducted an audit on the natural health product industry after it published an official call-up notice in February 2002. For eleven years since, it received applications for over 14 000 natural health products manufactured and/or sold in the country. Just how the MCC will find the capacity to evaluate and register this volume of products before the 2019 deadline defies logic, considering their dismal performance thus far.
TNHA RESIGNS FROM THE CAMs WORKING FORUM (CWF)
At the above mentioned CWF meeting, Gouws refused to grant the CWF official recognition as an industry task group which could officially represent the natural health product sector to the MCC, despite it being the largest broad-based natural health stakeholder group ever to have been formed. She insisted that the CWF motivate for inclusion as a sub-committee of the existing Industry Task Group (ITG) for the pharmaceutical sector.
The TNHA rejected this proposal, as the natural health product sector requires its own official bargaining body with a Memorandum of Understanding with the MCC, just as has been afforded to Big Pharma. The MCC errs in permitting special standing to Big Pharma, while natural medicine is reduced to sub-ordinate, orphan status.
The natural health product sector represents over 14 000 products and is estimated to be an R8-billion per annum industry. It is also a sustainable and significant source of job creation and local wealth creation. It has a value chain which is unique and separate from that of the pharmaceutical sector, and its products are not pharmaceutical drugs. In creating a separate medicines category for natural health products, termed ‘Category D’, the MCC has already differentiated them from pharmaceutical products, ‘Category A’.
We believe that Gouws’s attempt to subjugate the natural health products sector under an existing pharmaceutical domain may be a ploy to stifle the growing voice of dissent in the natural health products industry, which is galvanising its members and alliance partners to challenge to the unconstitutional, irrational and inappropriate MCC medicines regulatory system.
Gouws, by not allowing CAMS rolepalyers to have a voice and their their own Directorate within the MCC, gives undue power, influence and control to the ITG, a body largely made up of pharmaceutical regulatory consultants and Big Pharma employees. This in effect gives the drug companies carte blanche to expropriate and subordinate the natural health sector under its control.
This oppression has been a deliberate strategy by Big Pharma globally over the past 15 years, with the goal of crushing or diluting natural health options available in sovereign nations.
The TNHA has lodged objections to this proposal, apparently crafted by Gouws, and has demanded that she provide our organization with official minutes of her full Council’s meetings where the decision was made to have the CWF fall under the pharmaceutical ITG. Gouws is an administrative functionary of the Council, not an authorised policy maker, and it is not clear on what grounds she assumes the authority to which alienate our rights and access to participation on equal terms to other stakeholders. We eagerly await her response in this regard.
The TNHA took the decision last week to resign as members of the CAMS Working Forum, so as not to fall into the MCC / Big Pharma regulatory trap, and will not be participating in this forum any longer.
We will continue to lobby for a fair and appropriate regulatory framework for natural health products, and the repeal of the draconian regulations published in 2013 (as amended).
The TNHA has grown into a robust organisation over the past year, and represents a broad array of stakeholders across the traditional & natural health value chain. We remain committed to the survival of the Natural Healthcare industry.
Our alliance partner, the Health Products Association (HPA) has joined the pharmaceutical ITG, with reservations, under the banner of what remains of the existing CWF Technical Committee. Is there any chance whatsoever that small and medium sized natural health product companies (not Big Pharma companies which also sell CAMS) will have their voice heard and their interests protected within the ITG? Only time will tell.
THE TNHA WILL CONTINUE TO SERVE THE INTERESTS OF NATURAL HEALTH PRODUCT PRACTITIONERS AND MANUFACTURERS
It is clear that the divide between the interests of pharmaceutical and natural health product sectors is widening, and that our local natural health practitioners and companies will at some point have to decide whether they wish to be associated with the CAMS sector envisaged by Big Pharma interests (high volume, low potency, essentially ineffectual products, stocked in every superstore, or available by prescription only and still controlled by the drug companies), or the original natural health product industry which has been growing for decades (innovative, accessible, correct potency, high valued products which preserve health and vitality).
The TNHA represents the latter, and will continue to strengthen its rapidly growing alliance by lobby the legislature, exposing the current regulatory system manipulations and its architects, challenging the Medicines Control Council and as a last resort, challenge the laws through a strong Constitutional Court application, which has already been drafted and paid for.
We welcome all stakeholders to join the TNHA, whether they are raw ingredient suppliers, manufactures, importers, retailers, individual allied health practitioners, integrative medical doctors and therapists and concerned citizens who use natural health products. We call upon all interested and affected parties to join with us to restore the rightful place of natural health systems in our country.