Tag Archive | food labelling

Medicines Bill : focus on foodstuffs

DOH responds on new Medicines Bill……

patientDr Anban Pillay, DDG of the department of health (DoH), has made it quite clear in answering public comments on the proposed amendments to  the Medicines and Related Substances Act  that their concerns regarding foodstuffs are not just confined to the labelling of food and providing a list of the contents of any food products but also the actual food content itself contained in the product and any harmful effect it might have on the consumer.

In this regard, Dr Pillay has said there was to be much closer contact between DoH and the department of Agriculture, Forestry and Fisheries (DAFF), the lack of co-ordination becoming apparent during the recent scandal when horse meat and donkey meat had been discovered in the contents of named foodstuffs brands without any public awareness to this effect.

This and many other comments were made on submissions recently put before the parliamentary portfolio committee on health during the debate on the Medicines and Related Substances Amendment Bill.

No separation from cosmetics

Dr Pillay also made it quite clear that comments in submissions suggesting that food stuffs and cosmetics be isolated into separate legislation parallel with medicines and related substances was a non-starter.  DoH, he said, had already recruited 25 new permanent staff members that would be working for the South African Heath Products Authority (SAHPRA) who were in the process of considering a food agency, food being very much within the ambit of the one Act.

A good number of the changes in the Bill before Parliament arose in the area of vitro diagnostics (IVD), or tests with equipment which assisted medical diagnosis by sampling body tissue and fluids.    In this regard, the wording of international medical regulatory bodies had been used whereby such equipment had to meet certain performance requirements. This was in contrast to medicines and related substances issues which dealt primarily with matters of efficacy.

Big retailers excluded

On the question of the issue of licences to trade issued by the new Medical Control Council (MCC), it had been conceded that retailers dealing exclusively with bulk products classified as unscheduled medicines did not have to comply with all SA Pharmacy Association requirements or obtain a licence from the MCC.

Comments in submissions had been made and by the opposition that the regulating body would find it difficult to exercise its authority with regard to product advertising in all forms of electronic media, particularly if it extended to social media.  Dr Pillay said that this was acknowledged but he asked for his detractors to note that advertising and marketing world was an ever-evolving subject and attempts had to be made to deal with false claims and failure to meet requirements in all forms of advertising media whatever the problems of doing so.

Debate on medical devices

Regarding criticism on the descriptions and definitions in the amending Bill with regard in the approval of medical devices and the ambits of inclusion and exclusion, Dr Pillay said DoH had fallen back on an updated version agreed upon by the International Medical Device Regulatory Forum, which was more appropriate, he said.

Considerable debate took place upon the issue of controls on pricing, raised in a number of written submissions. DoH had agreed that the amendments would clearly state that the agreed pricing committee would be the final body to make recommendations on such matters to the minister of health. Meanwhile, the MCC would confine its activities to quality, safety and efficacy, not pricing.

Furthermore, Dr Pillay confirmed it was the pricing committee alone who were to “pronounce on marketing, bonusing and pricing matters”, bonusing usually being related the incentives to doctors to recommend certain medicines in relation to price.

Traditional medicines

As expected, the EFF and the ANC raised the question of traditional medicines and asked why there was no reference to such in the “description of medicines and products”.  On this, Ms Malebona Matsoso, DG of DoH, replied that department was fully aware of the need to incorporate traditional medicines.

She said that DoH was now distributing a booklet on the process they intended to use to regulate for traditional medicines and how DoH planned to carry out any regulations. The booklet was not available at the time but would be sent to parliamentarians, she said.

The DG, DoH, said that eventually SAHPRA would regulate all products that were processed in laboratories as well as the plants that were used during the process of making medicines. She explained that one of the main drivers for the establishment of SAHPRA was that MCC appointed members were contributors from different industries and not only public servants.

The establishment of SAHPRA therefore would be on a permanent DoH staff member basis and would deal with this as well as foodstuffs and cosmetics in terms of “products” under the Bill. Ms Matsoso confirmed again that traditional medicines and products had not been excluded under the Bill since the Bill included all products. How the regulations were to be extended to include traditional medicines was now being established, she said, and university research particularly from the University of the Western Cape and UN World findings would be used.

Animal world

Despite some objections in written submissions, DoH was insistent that veterinarians had to ensure that they were issued with licences wherever medicines were either compounded or dispensed. Also, Dr Pillay pointed out that the new Bill would not regulate for electronic-medical and radiation devices, the worry of one submission, and hence the question of the Hazardous Substances Act did not arise, he said.

In an earlier meeting with the DoH, also led by Dr Anban Pillay, the portfolio committee debated the section of the Medicines and Related Substances Amendment Bill that covered the formation and running of SAHPRA. What SAHPRA would do and the manner it would operate in the industry, he said, would be dealt with by the regulatory process to be devised.

Other articles in this category or as background
http://parlyreportsa.co.za/health/medical-food-intellectual-property-tackled/
http://parlyreportsa.co.za/health/sa-allow-avoidance-medical-patents/
http://parlyreportsa.co.za/health/medicines-and-related-substances-bill-now-tabled/

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