E-Drug: An "enforceable code of marketing practice" for South Africa?
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[Warning, long post. This gives details of some of the South African regulations to regulate marketing of medicines but points out the problems or self-regulatons and of regulating marketing of complementary medicines. This is specific to the South African situation but may be of interest to those addressing similar issues in their country. You may need to fix long URLs to access links to websites. DB - moderator]
Hi all
South Africa's National Drug Policy, published in 1996 but never updated, contained this policy prescription: "Ethical criteria and guidelines for the promotion and advertising of drugs will be established, widely disseminated and strictly enforced."
In 1997, amendments to the Medicines and Related Substances Act (Act 101 of 1965) introduced this section:
"18C. Marketing of medicines
The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice."
Although draft regulations were published in 2004, these were never finalised.
Now, it has been announced (see BDay story below, copied as "fair use") that the Advertising Standards Authority of South Africa will recognise a largely self-regulatory system as meeting the requirements of the Act. The agreement of the Medicines Control Council - the medicines regulatory authority for SA - is also implied. The details of the new "enforceable" code can be seen in Appendix A ("Medicinal") at http://www.asasa.org.za/Default.aspx?mnu_id=44
However, confusingly, there is also Appendix H ("Over-the-counter medicines"), at http://www.asasa.org.za/Default.aspx?mnu_id=51 - a very basic code adhered to by the Self-medication Manufacturers' Association of SA (SMASA), which is also a signatory to the new code.
The new code is supported by the following industry groupings and their member companies, as well as the individual pharmaceutical distributors:
* Innovative Medicines SA (IMSA)
* National Association of Pharmaceutical Manufacturers (NAPM)
* Pharmaceuticals made in SA (PHARMISA)
* Pharmaceutical Industry Association of SA (PIASA)
* Self-medication Manufacturers' Association of SA (SMASA)
* National Association of Pharmaceutical Wholesalers (NAPW)
* The South African Animal Health Association (SAAHA)
* South African Medical Device Industry Association (SAMED)
* Southern African Laboratory Diagnostics Association (SALDA)
This is the claimed legal backing for the new code:
"SA Code of Practice for the Marketing of Health Products Department of Health: Medicines Control Council (MCC)
1.Preamble
Whereas
1.1 Section 18C of the Medicines Act 101 of 1965 (“the Act”) empowers the Minister, after consultation with the pharmaceutical industry and other stake holders, to make regulations relating to the marketing of health products, including an enforceable Code of Practice;
1.2 the companies in the healthcare industry have agreed to subscribe to a code of practice for the marketing of health products in South Africa based on the principle of self regulation as set out in this Code;
1.3 the enforcement of the Code will be entrusted to a Marketing Code Authority (“MCA”) as herein provided."
Then, in the Introduction"
"This Code is issued in terms of section 18C of the Medicines and Related Substances Act No 101 of 1965, as amended, and is adopted by health products trade associations to signify the industry’s commitment to ensure that the marketing of health products to healthcare professionals and the public is carried out in a responsible, ethical and professional manner, based on practical and scientifically validated information.
The health products industry is committed to educational and promotional efforts that benefit patients and promotional programs and collaborations that enhance the rational use of health products and fair competition in the marketing thereof. The industry seeks to preserve the independence of the decisions taken by healthcare professionals. The industry has an obligation and responsibility to provide accurate information and education about its products to healthcare professionals in order to establish a clear understanding of the appropriate use of health products. Industry relationships with healthcare professionals must support, and be consistent with the professional responsibilities healthcare professionals have towards their patients.
This Code takes cognisance of other professional and industry codes applicable to the health products sector and professions with which the sector interacts."
However, the greatest weakness, as alluded to in the BDay story below, is the lack of commitment from the complementary medicines industry:
"2.2 Application of the Code
2.2.1 The Code is applicable to the following organisations and situations:
2.2.1.1 All registered health products licence holders, their agents, contractors, third party distributors/ marketers and/or contracted events organisers. Companies that circumvent the Code by engaging or using other companies, agents, contractors or dispensing system software vendors or ordering systems will be infringing the Code.
2.2.1.2 All advertising and/or promotion and promotional activities and communication directed at influencing any member of the medical, dental, pharmaceutical, nursing or allied health professions or any seller of health products who in the course of his or her professional or other activities may prescribe, purchase, supply, administer, loan or lease a health product or recommend the use thereof.
2.2.1.3 All advertising and/or promotional material, which is directed to members of the public to inform the general public about the health products available for self medication.
2.2.1.4 All advertising and/or promotion and all activities directly or indirectly related to marketing which may reflect on the marketing practices of the industry, including but not limited to sponsorships, patient information-sharing, meetings and entertainment.
2.2.1.5 Interactions between the industry and healthcare professionals (Part A) and the l industry and the general public (Part B).
2.2.2 The Code does not apply to the following situations:
2.2.2.1 Factual, accurate, informative announcements and reference material concerning registered health products and relating, for example, to adverse reactions and warnings.
2.2.2.2 The following documents are not covered by the Code:
2.2.2.2.1 Trade catalogues to suppliers including price lists.
2.2.2.2.2 Product labels, packaging materials and in-pack leaflets. These are subject to the labelling and package insert requirements in terms of the Regulations to the Medicines Act and the Guidelines pertaining thereto.
2.2.2.3 The marketing or promotion of complementary medicines and Stock Remedies as defined under Act 36 of 1947."
Without a workable definition for "complementary medicines", the loophole is a mile wide.
The BDay story also mentions the exclusion of the perversities that have arisen as reactions to the ban on bonusing and other forms of incentives - this is a rather hopeful statement: "2.2.2.4 Issues relating to pricing, bonusing and perverse incentives governed elsewhere in legislation and in codes issued in terms of the Medicines Act, National Health Act No 61 of 2003, etc."
A key requirement of the National Drug Policy and the Medicines Act is that the code should be enforceable. Here is the enabling provision in the code", liberally peppered with contingencies ("may include" ....)
‘2.6 Part D’ “ Provision for enforcement
2.6.1 The Code is based on the principle of self regulation of the industry through a procedure for handling complaints which is in line with international standards and practice, but made binding through the legislative recognition of the self-regulatory and subsequent processes which may include the medicines regulatory authority.
2.6.2 The process of enforcement and the relevant bodies responsible for such enforcement are set out in Part D of this Code.
2.6.3 The MCA has the power to refer issues not within the scope and ambit of this Code to the appropriate authorities, councils or bodies with the authority to deal with such issues.
2.6.4 The MCA has the power to outsource any of its enforcement functions
in terms of the provisions set out in Part D of this Code and/or to align its administration with that of other Codes in force in the healthcare sector at any point in time."
A great deal will depend on the status of the MCA, and on its ability to react in a timeous fashion and with meaningful penalties, so that these are not merely factored in as a business expense, to be met AFTER the marketing opportunity has been exploited:
‘Part D’ “ Provision for enforcement of the code
48. Self-regulatory enforcement of the code of marketing practice
48.1 The MCA is hereby recognised as the self-regulatory authority for health products, which authority is properly constituted by means of a Constitution as a juristic body.
48.2 The MCA shall have the power to create the required enforcement mechanisms in line with the provisions of this Code and in line with its Constitution and shall have all the powers necessary to ensure an efficient and effective self-regulatory mechanism.
48.3 The MCA processes constitute the first steps in any dispute or complaint relating to the provisions of this Code, and any aggrieved party may, after exhausting all the internal remedies provided in this Code, approach the relevant regulatory authority for resolution of a matter which it deems not to have been resolved satisfactorily and the MCA has the power to refer any matter prior to its final internal resolution to any relevant Authority should it deem the matter to warrant such a referral.
48.4 All signatories to the Code shall apply to be members of the MCA and shall have the rights and responsibilities as set out in the MCA Constitution."
The BDay story mentions fines of up to ZAR300 000 - is that meaningful? Would it pay for a single TV spot or a full page spread in a national newspaper? Here's the enabling provision:
"53.3 An Adjudicating Committee shall, in cases of a breach or contravention of the Code, have the power to impose on a Party any one or more of the following penalties:
53.3.1 a reprimand; caution or warning;
53.3.2 a fine, within limits set from time to time by the MCA in terms of its Constitution;
53.3.3 issue a directive that the Respondent’s internal procedures be audited by a representative of the MCA and that a report be furnished to the Executive Officer after the conclusion of such audit;
53.3.4 issue a directive that any offending promotional activity or material or advertisement be ceased and/or withdrawn forthwith and that satisfactory proof be provided, within a stipulated time period, to the Executive Officer that this has been done;
53.3.5 that the Respondent, as represented by himself, or in the case of a company by its Chief Executive Officer, Country Manager, Company Code Compliance Officer or other senior member of management, furnish a written undertaking within a stipulated time period that the Respondent will avoid similar breaches of the Code in the future;
53.3.6 that such action be taken by the Respondent to publicly undo the damage or potential damage caused by or as a result of the breach of the Code;
53.3.7 that the Respondent pay such costs and expenses as the Adjudicating Committee considers just and equitable in the circumstances including an order that the Respondent refund the Complainant the amount of the complaint fee;
53.3.8 that the finding of the Adjudicating Committee be published to the Members;
53.3.9 such other order as may be considered appropriate to the Adjudicating Committee in the circumstances."
Nonetheless, the code does include some interesting ideas. Here's a selection:
* "The promotion of a medicine must be in accordance with the terms of its registration, and must not be inconsistent with the particulars listed in its package insert."
* "Promotion material must encourage the rational use of health product by presenting it objectively and without exaggerating its properties. Exaggerated or all-embracing claims must not be made and superlatives must not be used except for
those limited circumstances where they relate to a clear fact about a health product. Claims should not imply that a medicine, active ingredient or health product has some special merit, quality or property unless this can be substantiated."
* "When promotional material refers to (unpublished) data on file, the relevant part of this data must be provided without delay at the request of members of the health professions or appropriate administrative staff.
If confidential information, such as information relating to trade secrets, sensitive commercial information or information of a competitive nature is involved, the material may be given to an independent arbitrator acceptable to both parties or a person appointed by the MCA from its Adjudication Panel for assessment, in the case of a dispute. The arbitrator or person appointed by the MCA will make an assessment as to whether the unpublished data in fact support the statement(s) made in the promotional material."
* "The word “safe” or words containing references to safety must not be stated in such a way as to imply that a product has no side effects, toxic hazards or risk of addiction. The word “safe” must not be used without scientific qualification and substantiation."
* "Clinical trials should not be undertaken for the purpose of promotion of health products intended for administration to human beings."
* "Promotional material and activities must not be approved nor issued unless its final form, to which no subsequent amendments will be made, has been certified by an individual on behalf of the company i.e. the Company Code Compliance Officer. Company Marketing Personnel and Medical Sales Representatives must ensure they obtain the necessary approval from the Company Code Compliance Officer prior to placing adverts in any publications and/or forums."
* "Speakers should use the INN names of products during CPD events. Companies must make it known to speakers that the use of trade names is not permitted."
* "No stand-alone entertainment or other leisure, social or sporting activities may be planned, arranged or funded by companies as these are unrelated to the promotion of scientific or educational objectives."
* "An inexpensive gift not related to the practice of medicine, the value of which will determined by the MCA, may be given as a maximum of one gift per year to healthcare professionals, in recognition of significant national, cultural or religious days. The maximum value of the gift must be in line with the value of general gifts.
Note:
The Medical Device and IVD industry may not give gifts pertaining to cultural, religious or national events."
* "Access to promotional material directed at the South African public provided on the Internet in relation to Schedule 02 to Schedule 06 should be limited through a password protection scheme to healthcare professional."
[Schedule 2 substances are supplied by a pharmacist, without a prescription, but cannot be advertised to the public, whereas Schedule 3-6 substances are prescription-only; DTCA is not allowed in SA; Schedule 1 substances are sold in pharmacies only, but can be advertised to the public, whereas S0 are available from all retail outlets]
* "Advertising and/or promotion shall not suggest that a product is herbal, unless all the active ingredients are plants or extracts of plants. “Herbal” can only be used to describe those elements that are of plant origin e.g. “herbal ingredient”."
* "Testimonials should be less than three years old and be the genuine views of the user."
* "An advertisement must not offer any personal incentive to a pharmacy assistant, or other non-healthcare professional sales person at retail level, to recommend or supply medical devices."
The exact role of the Advertising Standards Authority of SA in this new system is as yet somewhat unclear. Is this really an "enforceable code of marketing practice" for South Africa?
regards
Andy