Medicines and Related Substances Amendment Bill: hearings

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Health

16 September 2002
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Meeting Summary

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Meeting report

PORTFOLIO COMMITTEE HEALTH
17September 2002
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL: HEARINGS

Chairperson: Lincoln Ngculu

Documents handed out
Submissions from:
Health Professions Council
National Association of Pharmaceutical Manufacturers
Aidslaw
National Convention on Dispensing
Afrox Healthcare Ltd
Society of General & Family Practitioners
South African Medical Association
Pharmaceutical Society
Board of Healthcare Funders
South African Pharmacy Council
COSATU
PMA Comment on Draft Medicines and Related Substances

Summary:
Representatives of various interest groups presented their comments on the Medicines and Related Substances Amendment Bill to the Portfolio Committee on Health. Submissions were presented by the Health Professions Council, the National Association of Pharmaceutical Manufacturers, Aidslaw, the National Convention on Dispensing, Afrox Healthcare Ltd., the Family Practitioners Association, the Pharmaceutical Manufacturers Association, the Society of General and Family Practitioners, the South African Medical Association, the Pharmaceutical Society, the Board of Healthcare Funders, and the South African Pharmacy Council. In addition to members of the Committee, individuals present at the hearings included the Director-General of Health and officials from the Department of Health (DOH) and Medicines Control Council (MCC).

Presentation by HPCSA
The comments of the Health Professions Council of South Africa were presented by Dr C.M. Kruger, Dr. M Dlomo, and Adv. B.M. Mkhize.

The HPCSA provided comments on several aspects of the principal Act, including:

1. Definitions of the terms "medical Act," "medical devices," "medical practitioner" and "practitioner";

2. Sections 3 and 6 specifying the composition of the Medicines Control Council, which the HPCSA believes should be constituted by experts in different professions and fields of practice relevant to the issues regulated by the envisaged amendments, in order for such experts to consider vital matters and issues which have or may have a profound impact on healthcare in South Africa;

3. Section 22C, regarding the licensing of practitioners to dispense medicines;

4. Section 22E, which the HPCSA suggests should be revised in order to eliminate any possible conflict or contradiction between the powers already vested with the Medical and Dental Professions Board in terms of Chapter IV of the Health Professions Act, 1974, and the powers vested in the Director-General in terms of S.22E;

5. Section 22F, concerning professional responsibility and legal liability with respect to substitution of a branded medicine by an interchangeable multi-source medicine, with respect to which the HPCSA recommends that a pharmacist only be permitted to substitute after consultation and agreement with and by the prescriber.

Dr Kruger noted that fruitful discussions had occurred between the HPCSA and Pharmacy Council, at which the two bodies agreed more cooperation was necessary. As technology advances, the gray areas between the medical and pharmaceutical professions will expand. For example, some compounding and dispensing of medicines has been evolved to registered doctors. The HPCSA foresees a problem if different statutory bodies exert authority over individuals regulated by other boards. Issuing of licenses for dispensing should be retained by the HPCSA for medical and dental practitioners. Through the CPD points system, the HPCSA can ensure that practitioners are evaluated and ethical standards maintained.

Questions and Discussion
Ms Rabinovitch (IFP) noted that the bill had originally been passed in haste, and that the IFP had opposed it. She stated her hope that she would be able to support it this time. Ms Rabinovitch posed three questions to the HPCSA:

1. Since it is easier to hold practitioners accountable when they have been licensed on the basis of objective qualifications, should licensing take account of need?

2. As loopholes tend to arise in situations of legislative duplication and overlap, should alternative medicines (acupuncture, Chinese medicine, etc.) be brought under the HPCSA?

3. What is the distinction between "practitioners" and "therapists?"

Adv. Mkhize (HPCSA) responded the HPCSA deals with standards, training, and knowledge, and cannot be involved in any determination of licensing need.

He encouraged the DOH to respond to question regarding alternative practitioners, noting that this was not an area in the purview of the HPCSA.

Adv. Mkhize also explained that there is no particular criteria confining the terms "practitioner" and "therapist." It is the HPCSA's position that the term "practitioner" should be universalized.

Ms Mnumzana (ANC) was pleased with the requirement that dispensers consult with prescribers before substituting a drug, but asked whose responsibility it would be to monitor this obligation.

Dr Dlomo (HPCSA) explained that only a phone call was necessary, enabling the prescriber to endorse a substitution, for reasons of professional responsibility and legal liability. The Pharmacy Council might play a role in monitoring.

Mr Cachalia (ANC) asked whether a drug substituted by a pharmacist should not be an exact replica, and if so, is consultation really necessary? If a drug has gone through the MCC process and been placed on shelves, where to problems arise?

Dr Kruger (HPCSA) noted that his organization is not against generic substitution, and that the drugs used as substitutes should be as good. HPCSA is merely asking for a clause requiring consultation for the simple reason that patients often return to prescribing doctors for a renewal, and the prescriber must be aware of any substitutions made. It is simply good practice to have better consultation.

Mr Jassat (ANC) asked whether, with respect the redefinition of medical devices, the term "related substances" might not be sufficient. He also inquired as to whether some tightening of the definition of "generic substitution" might not be possible, particularly in relation to bioequivalence or bioavailability.

Dr Kruger stated that he had full confidence in the MCC, and expressed his opinion that it is the prerogative of pharmacists to suggest to prescribers a generic substitute. It should be required that liaison occurs.

Referring to the term "related substances" and its usefulness with respect to medical devices, Dr Kruger said that the two terms are not necessarily mutually reinforcing. Devices are objects, while "related substances" tends to encompass drugs and medications only.

Ms Luthuli (ANC) expressed her support for the requirement of consultation by dispensers when substituting a generic medicine.

With regards to generic medicines, Ms Malumise (ANC) asked how pricing would be controlled. Are there ways to make the public aware that generics are just as good as name-brand medicines?

Dr Kruger replied that price control is not within the ambit of the HPCSA, though he noted that ethical practices in with respect were important.

Mr Ngculu (ANC) observed that the prescriber should generate options prior to dispensation. He also noted that collusion between dispensers and prescribers might produce perverse incentives.

Presentation by NAPM

The comments of the National Association of Pharmaceutical Manufacturers (NAPM) were presented by Dr M. Mabenge and Mr M. Bodhania.

In his preamble, Mr Bodhania noted that the NAPM represents the generics industry and local manufacturers, not multinational corporations (MNCs). For the NAPM, the central issues of concern with respect to the Bill are: the pricing committee, the single exit-price, and the marketing code of practice.

The pharmaceutical value chain is immense, and the pharmaceutical industry occupies its back end. In the last five years, there has been intense competition and the proportion of generics in the market has nearly doubled, but prices have not changed more than 1%, meaning that volume has been lost along the value chain. The reality of the industry is high costs and perverse incentives, but the problem is not merely at the back end. Doctors are also responsible for the proliferation of practices such as sampling and bonusing. For this reason, the NAPM welcomes the salient aspects of the Bill. Generic substitution and professional fees will help bring prices down, and the marketing code of practice will impose control and sanity on the industry. Some aspects of the Bill, however, may prove counterproductive.

Volume discounts must be permitted, since this is a legitimate practice distinct from perverse incentives (sampling, bonusing). The Bill's prohibition is too broad.

As constituted, the pricing committee is in conflict with free trade principles. Price controls will be anti-competitive and drive up costs to end-users. It is important to clarify the extent and modus operandi of the committee, and its membership must include all stakeholders.

The single exit-price should be changed to a net price, allowing for volume discounts. Perverse incentives can be easily detected on accurate invoices. This will allow for transparency without a ban on volume discounts, which will lower prices. A single exit-price also limits access to lower schedule drugs, which at the very least should be excluded.

NAPM opposes the omnibus clauses that invest the Minister and Director-General with enormous power. Their discretion must be more carefully regulated.

NAPM proposes a pricing model that is transparent, a mixture of government and industry regulation that will leverage existing infrastructure, such as the MCC and Pharmacy Council inspectors.

NAPM opposes international tendering without the requirement that MNCs partner with local companies. Any international tendering must take place within a context of free trade principles, WTO compliance, and no fast-tracking of registration for MNCs.

Questions and Discussion
Ms Gxowa (ANC) asked how price control might be established.

Mr Bodhania (NAPM) replied that there is currently not national control of medicines costs. While he acknowledged that there are perverse incentives in the marketplace, he stated that he was uncertain whether price differences are the result of commercial issues or perverse incentives.

Mr Cachalia (ANC) asked if the Pharmacy Council would be represented on the pricing committee.

According to Mr Bodhania, the NAPM, PMA, provider and funder bodies should all be represented on the pricing committee.

Mr Cachalia noted the difference between exit-price and base price. Is the NAPM prepared to give a breakdown on exit-price vs. base price? If you give a volume discount, is the saving certain to trickle down to the end-user?

Mr Bodhania explained that many factors impact the final exit-price, and that it would be difficult to accept one single price.

The benefits of volume discounting do not always trickle down to consumers because of margins and perverse incentives. Sales to big chain stores will ultimately make drugs more accessible, and this legislation interferes with that process.

Ms Rabinovitch (IFP) commented on the contradictory aspects of the legislation. She also remarked that the industry has had five years to "get its act together," and asked why it has not been able to move generics forward and reduce the cost of medicines? Why has the industry not regulated itself? She requested details regarding its proposed transparent pricing system. She also noted that, with respect to HIV/AIDS, businesses are now buying anti-retroviral (ARV) drugs for employees, and should be able to buy in bulk. How are they sourcing?

The industry has not regulated itself because suppliers are subject to market forces, and NAPM welcomes many aspects of the legislation that eliminate perverse incentives flowing throughout the value chain.

With respect to HIV/AIDS drugs, local manufacturers can help through voluntary licensing with MNCs, and in some situations, compulsory licensing. If the domestic generics industry was able to manufacture generic ARVs, it could lower prices.

Ms Luthuli (ANC) asked what is the reason for the escalation of generic drug prices? The lack of transparency in the industry must be addressed.

Mr Bodhania responded that the value of the market has remained static, even though prices have been rising. This is a result of the falling ran, which affects direct input prices (since 70% of the industry's costs is raw materials), and generics are still not used sufficiently (accounting for 18-22% of the market).

Ms Malumise (ANC) noted that sampling of medicines has benefited doctors most.

Mr Bodhania acknowledged that sampling has been abused. Sampling should be written into the law and banned, some sampling should be allowed if claimed on invoices. Practitioners who violate standards should be disciplined.

Mr Jassat (ANC) noted that volume discounting could benefit the end-user, but asked if it would also benefit the prescriber and dispenser.

Ms Rabinovitch stated that, if it would be helpful to have transparency between suppliers, this should be implemented.

Mr Bodhania suggested that the objectives of the NAPM and the government are shared, and a solution should be sought which is sensitive to industry concerns about information-sharing and independence. He reiterated his question regarding what the pricing committee will do? If it sets a single exit-price, the industry will object. There should be mechanisms to check perverse incentives, but not fix prices. He noted the example of India, where price controls have proven counter-productive.

Presentation by Aidslaw Project
The comments of Aidslaw were presented by Mr Jonathan Berger.

Mr Berger expressed Aidslaw's serious difficulty with the failure of the government of implement Act 90 of 1997. The provisions could have been implemented long ago. Five years since Act 90 was passed. Written submissions find unreasonable delays unconstitutional. Focus is not generics; this issue is non-negotiable. Rather, issue of independence of the MCC.

Act 90 and the amendments weaken the independence of the MCC. The fact that the provision referring appeals to the Minister has been dropped is pleasing. Aidslaw has seen with Act 90 and now with the bill before the Committee that all references to qualifications for MCC appointees have been dropped. In the Bill, if someone has been appointed on the basis of particular qualifications, someone with similar qualifications must not necessarily replace them. The fact that the Bill enables the Minister to decide who sits on the MCC is out of synch with other recent legislation (concerning broadcasting and the Council for Medical Schemes, to cite just two examples), which has set out qualifications for members and an open selection process. Furthermore, qualifications must be in the Act, not the regulations.

Aidslaw does not believe that the Minister of Health should be powerless. However, Parliament must guide and circumscribe the executive's exercise of public power. The authority of the Constitutional Court is on the side of this argument.

Parliament must also decide the terms of reference of the pricing committee, not the Minister.

Aidslaw has provided a redrafted Section 3 of the Act.

Mr Berger acknowledged that Aidslaw had not included much in its written submission on the topic of generics. He stated that Aidslaw and TAC welcome the medicine-specific licensing provision. Compulsory licensing elements in the Patents Act are in excess of TRIPS and not in line with the Doha agreement. Aidslaw would like to see medicine-specific compulsory licensing in all legislation for emergency situations. Medicines are not like other commodities and cannot be treated as such. The state has an obligation to consider human rights concerns above commercial interests.

The pricing committee must distinguish between patented and un-patented medicines.

Mr Ngculu (ANC) interrupted the presentation to warn Mr Berger that he could not diverge from the written submission.

Mr Berger concluded by noting that, in Act 90 of 1997, the legislation is not specific enough. Qualifications and the process of appointment for MCC members should be delineated.

Questions and Discussion
Mr Ngculu (ANC) stated that, contrary to Aidslaw's assertion, legislation cannot be selectively implemented.

Mr Jassat (ANC) noted that the stumbling block with respect to prices is not the price of generics as such, but the costs associated with laboratories, counseling, monitoring, etc.

Mr Berger (Aidslaw) agreed that the cost of generics was not the only issue. TAC has costed a comprehensive package and it is affordable. TAC is working with labs to bring some of their costs down.

Ms Rabinovitch (IFP) observed that most of the day's submissions were heard five years ago. She expressed her support for accountability and transparency in the industry. She asked whether compulsory licensing might not run the risk of introducing fraudulent products into the marketplace. Ms Rabinovitch also stated her belief that, had the government put out a tender for HIV/AIDS drugs in the five years since the introduction of Act 90, it could have taken overpricing MNCs to the Labour Department and demanded compulsory licensing under existing legislation.

With respect to compulsory licensing, Mr Berger agreed that the government has the power under the Patents Act to issue compulsory licenses. He also reiterated Aidslaw's position that provisions in the Patents Act are TRIPS+.

With respect to fraudulent medicines, he stated that the ordinary MCC regulation process would have to be followed and that fraudulence should not be an issue.

Mr Cachalia (ANC) asked how might the cost of ARVs be brought down in the private sector.

Mr Berger stated that TAC's position is that MNCs should be issuing voluntary licenses with 45% royalty rates and no export limitations.

Ms Malumise (ANC) asked whether Mr Berger could present examples of committees appointed in the past without necessarily qualified members?

Mr Berger responded that he was not aware of any examples, but that Aidslaw's position was based on principle and the possibility that abuses could occur.

Ms Kalyan (DP) asked whether homeopaths and other alternative practitioners might be included on the MCC.

Mr Berger responded that Aidslaw had no opposition to the presence of alternative practitioners on the MCC.

Referring to Aidslaw's request for distinctions to be made between patented and un-patented medicines, Ms Kalyan asked how this would benefit the consumer.

Mr Berger claimed that generic competition is a self-regulatory process that will reduce prices, especially of non-substitutable ARVS.

Mr Ngculu asserted that the legislation as it exists is necessarily less restrictive with respect to appointments to the MCC. He accused Aidslaw and TAC of impugning the government. TAC should be an ally of the government.

Mr Ngculu also asked what interests should be excluded from the pricing committee.

Mr Berger responded that the written submission did not constitute an attack on the government, and that he is not questioning the MCC's integrity.

He also noted that TAC had supported many aspects of the Bill. TAC views itself as an ally of the government that wants to strengthen this important legislation.

With respect to exclusion of specific interests from the pricing committee, Mr Berger stated that this would depend on the committee's terms of reference. If it sets prices, the presence of manufacturers is problematic. This returns to the problem of how much is set out in the legislation and how much will be contained in the regulations.

Presentation by NCD
The comments of the National Convention of Dispensing were presented by Dr M.N. Mabasa.

The NCD represents all dispensing doctors in South Africa. There are 8000 dispensing doctors in the country, each seeing approximately 30 patients per day, thus representing millions of patients per month.

NCD has consistently submitted that the requirement that medical practitioners obtain a license to dispense medicines:

1) is unnecessary having regard to the existing legislative provisions and powers of the state,
2) will adversely limit the access to health care by persons who have limited financial means rather than enhance the delivery of health care services,
3) will lead to an infringement on the constitutional rights of medical practitioners,
4) will place an unwanted and excessive burden on the already strained global health budget,
5) may well serve to increase the prices of medicines as a result of the elimination of competition currently provided by dispensing medical practitioners.

The NCD proposes that:

There should be no requirement for medical practitioners to obtain a license in order to continue dispensing medicine, as they are at present entitled to do so in terms of existing legislation.

The existing legislation effectively implemented is adequate to regulate dispensing doctors.

Medical practitioners who are registered in terms of S.52 of the Health Professions Act 56 of 1974 be required to successfully complete a relevant course prescribed by the HPCSA in consultation with the Pharmacy Council. This can easily be incorporated as an addition to the existing CPD requirements for dispensing doctors.

Dispensing doctors undergo updates of this course at stipulated intervals (every five years) in order to maintain their registration. These updates should be part of the CPD programme.

Dispensing doctors should be required to comply with a code of good dispensing practice. The NCD commits itself to take part in drawing up such code in consultation with other stakeholders under the auspices of the HPCSA.

The NCD submits that the Bill, in its present form, should not be proceeded with for the reasons set out herein. In the event of a decision being taken to proceed with the Bill, the NCD requests that an amended draft of the Bill be issued, taking into account the submissions expressed to the Committee, and that this be published together with an amended draft of the regulations to be read with the Bill. Interested parties, including the NCD, should then be allowed a further period of time within which to make submissions in regard to the amended Bill and amended regulations.

Questions and Discussion
Ms Gxowa (ANC) asked, when the NCD speaks of dispensation, how can those who have abused the prerogative be removed?

Mr Mabasa (NCD) replied that the government should be able to oversee and investigate, and monitoring should be part of the bill.

Mr Jassat (ANC) asked if the NCD was suggesting that dispensing should be universal for all GPs?

He also noted that composite fees mean people in poor areas will be subsidizing those in richer communities.

Mr Mabasa responded that the poor may not necessarily pay.

Mr Ngulu (ANC) noted that appeals to the DG and Minister do not preclude appeals to the judicial system. Nor does the legislation prohibit dispensing by doctors, it merely requires that they be licensed. Not all doctors are currently qualified to dispense all medicines (especially ARVs). What is the NCD's proposal—should doctors be licensed or not?

Mr Mabasa said that he does not want to see the courts deciding simple license applications. Confrontation in the courts should be a final resort.

He restated the NCD's position that, even without the new legislation, there is no need for licensing. He also noted that doctors must be trained in the treatment of HIV/AIDS, and want a role in treatment.

Mr Ngculu asked for the NCD's position on consultation between dispensers and prescribers.

Mr Mabasa stated his conviction that collusion would not be a threat, and the NCD's support for the legislation's provisions on consultation.

Presentation by Afrox Healthcare Ltd.
The comments of Afrox Healthcare Ltd. were presented by Ms Ansuyiah Padayachee.

Afrox Healthcare is a private healthcare group, and commented primarily on S.18A1 and S.22G.

Questions and Discussion
Ms Kalyan (DP) asked who should be on the pricing committee.

Ms Padayachee (Afrox) responded that Afrox supports the composition of the committee as reflected in the legislation, so long as all stakeholders are engaged.

Ms Rabinovitch (IFP) asked why the price of medicines has not come down. Has the overall cost of drugs for Afrox's patients come down?

Ms Padayachee responded that the cost of drugs has come down, and that she would be happy to share Afrox data with Ms Rabinovitch at a later time.

Mr Jassat (ANC) asked if in-patients pay the same as out-patients at Afrox's private hospital pharmacies. There is a perception that private hospitals overcharge for medicines.

Ms Padayachee responded that the legislation allows Afrox pharmacists to supply medicines only to its own patients. She expressed her hope that this would change. With respect to perceptions of private hospitals overcharging, Ms Padayachee averred that she could only speak on behalf of Afrox.

Mr Ngculu (ANC) asked whether bonuses and rebates represent a hidden cost to consumers.

Ms Padayachee replied that the single exit-price will be manipulated by manufacturers. A maximum price, as recommended by Afrox, will encourage competition under a specific price ceiling.

Ms Luthuli (ANC) observed that a maximum price might include all markups and defeat the price control objective.

Ms Padayachee stated that large entities should be able to provide drugs cheaper through their efficiencies.

Presentation by FPA
The comments of the Family Practitioners Association were presented by Dr B. Seetharan.

The FPA concedes that licenses for dispensing doctors can be removed, and is pursuing a process to facilitate this with the MCC. Dispensing doctors do not typically compound, but they administer injections, so the definition of compounding should be clarified. A code of good dispensing practice is crucial. There should be a positive obligation on dispensing doctors, with non-compliance a cause for the revocation of licenses.

The right to dispense should be based on competency alone, and the criteria incorporated into the Act. Requirements contained in the latest draft of regulations for license applications include geographic and demographic considerations and an opportunity for the submission of objections. Geographic and demographic data is not presently available, and furthermore, there is no commensurate requirement in the Pharmacy Act. This will deprive dispensing doctors of a longstanding right, and patients of affordable one-stop healthcare.

The FPA noted that generic substitution has not greatly reduced the price of certain medicines. Statistics from some countries indicate that generics have only slowed the growth in costs, not halted them.

Questions and Discussion
Mr Cachalia (ANC) asked why doctors should be licensed to dispense.

Mr Seetharan (FPA) stated that the licensing provisions in the current legislation are unnecessary, because the HPC has registered all dispensing doctors, representing a de facto licensing system.

Ms Kalyan (DP) observed that, in medical school, students are trained to dispense. Who is the licensing clause aimed at?

Mr Seetharan responded that the proposed licensing scheme includes psychologists, nurses, and other practitioners who dispense. HPC is a statutory body required to enforce competence and investigate professional misconduct.

Ms Rabinovitch (IFP) asked what impact the legislation would have on practitioners such as homeopaths and traditional Chinese doctors. Is it a good idea to have all practitioners registered by the same body?

Mr Seetharan replied that the intended proposal is a Pharmacy Council licensing system. His position was that this is unnecessary.

Ms Malumise (ANC) expressed her conviction that if the price of generic medicines is going up, the situation requires serious government intervention.

Presentation by PMA
The comments of the Pharmaceutical Manufacturers Association of South Africa (PMA) were presented by Ms M.T. Deeb and Ms M.W. Kirkman.

PMA represents research-based MNCs with substantial generic representation. PMA members represent 75% of the total market value in South Africa. PMA's objective is absolute clarity and certainty, and the clearing up of ambiguities in Act 90 of 1997.

Since its introduction as a Bill and later passage as an Act, several technical and legal flaws have been identified in Act 90 of 1997. These flaws have been widely regarded as having the potential to derail the government's sound objectives of ensuring access to quality and affordable medicines.

The following key issues are of major importance to PMA:

1. definitions in S.1, related to "interchangeable multi-source medicines" and "therapeutic equivalence";
2. parallel importation, as described in S.15C;
3. the Code of Ethics embodied in S.18C;
4. the Pricing Committee in S.22G;
5. generic substitution, as in S.22F;
6. the Appeal Committee, as described in S.24; and
7. the powers of inspectors around search and seizure, as in S.28.

PMA is also concerned with the constitution of the Medicines Control Council (S.3), disqualification for appointment to the MCC (S.6), reversion to the use of "The Minister of Health or Director-General as opposed to Department (S.22C, 22D, 22E, 22H, 24, 35), deputy registrar position (S.12), schedules of medicines (S.22A), licensing (S.22C, 22D, 22E).

PMA also observed that the introduction of the Bill as a Section 75 bill may be problematic. Act 90 was originally introduced as a Section 76 bill, and the Constitution is clear that legislation pertaining to health should be introduced via the Section 76 procedure. The ramifications of this confusion could undo the legislation.

Questions and Discussion
Ms Kalyan (DP) noted that the State Law Advisor has already alerted the DP to the Section 76 issue.

Ms Rabinovitch (IFP) inquired as to whether S.15C is necessary if the Minister vowed not to abrogate patents? It could take five years to override patents, so maybe S.15C is needed.

Ms Deeb (PMA) replied that S.15C will be used for parallel importation, not compulsory licensing. According to legal advisors, S.15C could take six weeks to override a patent; in a national emergency, this timeframe could be reduced to as little as two days.

Ms Deeb stated that the industry is prepared to public exit prices; concerns about the pricing committee revolve around implementation without disruption.

Ms Rabinovitch observed that prices have been going up, and asked whether transparency along the entire supply chain is the alternative to a fixed price.

Ms Deeb replied that no manufacturer will expose itself voluntarily. If it is imposed on all manufacturers, transparency will not be a problem. Discounts must benefit the end-user, but the introduction of a professional fee may not change the system for the better. The distribution chain must come down to international norms.

Presentation by SGFP
The comments of the Society of General and Family Practitioners (SGFP) were presented by Dr T. Terblanche.

The SGFP represents some 6000 general and family practitioners nationally, most of whom are also SAMA members.

Many doctors deliver a medicine dispensing service to bona fide patients: no "open-shop" or "off-the-street" dispensing, as per HPCSA rules. This has the full support of the SGFP which views dispensing as an integral component of the trust relationship between doctor and patient, with the latter having a choice as to where he or she wishes to obtain required medication, given the paucity of qualified pharmacists in South Africa and their skewed distribution. Any onerous additional dispensing licensing requirements may well limit access by these groups to readily available and regulated sources of quality, affordable medicines.

SGFP further emphasizes its strong commitment to encourage the use of quality generic medicines through peer and other forms of persuasion in the marketplace. In the same vein, SGFP supports the government's exploration of alternative-sourcing mechanisms for crucial medication and medical devices, while engaging the acknowledged MNCs positively.

SGFP strongly supports the implementation of well-structured compulsory dispensing education and training modules, in the case of its members, under the auspices of the HPCSA, as well as for the dispensing person to submit and commit to a legal and ethically-binding code of good dispensing conduct/practice, again under the primary jurisdiction of the relevant statutory professional body.

SGGP supports positive partnerships between government, professional associations, labour and consumer groups, and manufacturing and supply-chain actors to achieve a shared common vision of affordable and accessible medicines.

Questions and Discussion
Mr Ngculu (ANC) asked if the SGFP supported licensing.

Dr Terblanche (SGFP) expressed his support for the principle of licensing, but urged the strengthening of existing mechanisms. There should also be a reasonable, realistic lead time, probably two to three years.

Mr Cachalia (ANC) asked Mr Terblanche's opinion on the issue of primary health care clinics staffed by nurse-practitioners.

Dr Terblanche replied that primary health care clinics should be focused on family health.

Presentation by SAMA
The comments of the South African Medical Association (SAMA) were presented by Dr J. Terblanche.

Dr Terblanche expressed SAMA's strong support for the state's efforts. There are 8000 dispensing doctors already registered with the HPC, and it is the position of SAMA that it is not sensible to create a new licensing system. At the dispensing level, more teeth are needed in the legislation to deal with doctors. If a licensing system is introduced, it should be the HPC, not the DG and the Minister, that administers it. HPC can already sanction professional misconduct. Furthermore, SAMA insists that licensing should be based on competence, not other criteria (such as geography).

SAMA supports Continue Professional Development (CPD) points to ensure testing and upgrading, do not need a mechanism.

Codes of good dispensing conduct are useful to HPC to keep doctors to highest standards.

Questions and Discussion
Ms Luthuli (ANC) acknowledged that CPD points are important. She suggested that the system was cumbersome as it is, and that doctors are stretched for time and money to acquire points.

Dr Terblanche (SAMA) noted that, for those doctors in academic or surgical practice, obtaining CPD points is relatively simple. SAMA is working hard to facilitate the acquisition of points by all doctors. Costs must be reduced to accomplish this objective. Universities should be extending assistance to rural areas.

Mr Cachalia (ANC) noted that some practitioners have opted out of medical aid. This impacts negatively on the quality of care. Is there some way to bring home to practitioners the need to deliver affordable services?

Dr Terblanche stated that escalating costs in hospitals and in the pharmaceutical industry can be controlled. The cause of runaway costs is not GPs and specialists. SAMA bodies are working on the development of mechanisms to eliminate perverse incentives.

Ms Rabinovitch (IFP) asked why South Africa has failed to use existing legislation to regulate medical professionals? CPD is cumbersome, especially for doctors who have separate points with both conventional and alternative regulatory bodies.

Dr Terblanche acknowledged that a mechanism must be created to facilitate those practitioners regulated in both conventional and alternative therapies.

Mr Jassat (ANC) stated that doctors must acquire 50 CPD points annually, would points for dispensing competency be included in that 50?

Dr Terblanche replied that SAMA was assessing how the CPD system might be utilized.

Presentation by SAPC
The comments of the South African Pharmacy Council were presented by Prof J.S. Du Toit.

The South African Pharmacy Council is the governing body for all pharmacists, pharmacist's assistants, and pharmacies.

Comment is provided as deemed necessary for purposes of inter alia the execution of the activities of the SAPC:

Section 1

It is proposed that the term "pharmaceutical industry" also be defined as this term (concept) is used often in the contents of the Bill and could have different meaning(s) to different stakeholders. For example, does "pharmaceutical industry" refer to pharmaceutical manufacturers only or does it include pharmaceutical wholesalers/distributors and/or other categories of pharmacies?

It is proposed further that the terms "manufacturer," "wholesale dealer," and "distributor" be defined. One way of doing this is to, for example, define a "manufacturer" as a manufacturing pharmacy registered as such under the Pharmacy Act, 1974. The same could apply to "wholesale dealer" and "distributor." This approach would prevent ambiguities in the future.

The terms "compounding" and "dispensing" must also be defined. Draft definitions can be provided, if required. Definitions should, however, be in line with the provisions of the Pharmacy Act 53 of 1974, as amended.

Section 5(i)

A pharmacist must retain a prescription after the dispensing of any Schedule 3, Schedule 4, Schedule 5, or Schedule 6 substance. The patient will be in possession of the medicines concerned but not the prescription. This subsection thus needs to be redrafted to make provision for medicines that are in the possession of patients, after such medicines have been dispensed by pharmacists or other authorized persons in accordance with a prescription issued to the patient.

It is thus proposed that the new Section 5(i) should rather read: "any person may possess a Schedule 3, Schedule 4, Schedule 5 [,] or Schedule 6 [or Schedule 7] substance if supplied to him or her upon a prescription issued by an authorized prescriber."

Section 6

Section 6(b): Dispensing course

The two acts of "compounding" and "dispensing" which both specially pertain to the profession of a pharmacist are very different in nature, requiring different skills and knowledge, as well as supplementary courses. In terms of the amended Section 22C(2), a supplementary course must be determined by the SAPC. This section fails, however, to say what "supplementary course" should be determined, and leaves it to the reader to assume that it should be supplementary course in "compounding" and/or "dispensing." In a worse case scenario, it could be any supplementary course, as long as it was "determined" by the SAPC.

The section in question also fails to describe how compliance with minimum standards will be ensured. Once the SAPC has determined a supplementary course, who will provide such a course(s) and who will assure quality of the contents of the course?

The following amendment to remedy the situation could thus be proposed, viz:

"(2) A license referred to in subsection (1)(a) shall not be issued unless the applicant has successfully completed a supplementary course [prescribed under the Pharmacy Act, 1974, by the Interim Pharmacy Council of South Africa] in compounding or dispensing based on unit standards as determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa, the Allied Health Professions Council of South Africa and the South African Nursing Council, and such supplementary course complies with the minimum criteria for the approval of providers and courses as determined and published by the South African Pharmacy Council."

The above-mentioned amendment will bring the section in line with SAQA requirements and provide for quality assurance of the courses in question.

Section 6(e): Commencement of section

Act 90/1997 does not make provision for different sections of the Act to come into operation on different dates.

Section 8

The matter of a pricing committee determining a fixed appropriate (what is appropriate?) dispensing fee for pharmacists and/or wholesalers, needs to be reconsidered. The SAPC is authorized in terms of Section 35A of the Pharmacy Act 53 or 1974, as amended, to make rules as to the services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees. There could thus be a conflict between the two pieces of legislation. Furthermore, the Competition Commission has thus far been adamant that dispensing/professional fees may not be determined by way of regulations, but should be a negotiated fee. Is S.22G thus in line with the provisions of the Competition Act?

Section 9(f)

It is unclear and no advisable that the Director-General and the Minister as the persons responsible for policy and the ensuing drafting and publication of the appropriate legislation should also sit in sole judgment of an appeal against a decision taken in terms of the same legislation. Will such a situation promote administrative justice? There is also no further remedy available to any aggrieved person other than to take the Minister or the Director-General to court.

Questions and Discussion
In reference to S5.1, Ms Kalyan (DP) asked whether it was not normal practice that a pharmacist would hold the scrip.

Prof Du Toit (SAPC) responded that in order to obtain Schedule 3-4 drugs, the prescription should be in the possession of the dispenser.

Noting that minimal compounding is done by medical practitioners, Mr Jassat (ANC) asked whether it should be obligatory for practitioners to have competence in compounding.

Prof Du Toit replied that, in a meeting with the Medical and Dental Practitioners Board, a determination was made that the reference to compounding could be removed.

Mr Gauss (NNP) reminded the Committee that, in theory, pharmacists dispense and doctors "doctor," though this is not the case anymore. The original rationale for doctors being able to dispense has been distorted into a commercial issue. To a certain extent, each profession must "accept each other's bona fides" and move forward.

Prof Du Toit stated that diagnosis is incidental for pharmacists, and dispensing incidental for doctors. Trading in medicine has become central for many doctors, and this was not the original intention of the legislation.

Ms Kalyan asked for the Pharmacy Council's position on the pricing committee.

Prof Du Toit stated that the Pharmacy Council supports the Department of Health's proposal for price regulation. The Pharmacy Act and this bill must be consonant.

Mr Cachalia (ANC) noted that, in a developing country where the majority is without state health coverage, there is a place for dispensing doctors.

Prof Du Toit acknowledged the issue of need, in which case doctors must be allowed to dispense.

Presentation by BHF
The comments of the Board of Healthcare Funders of South Africa (BHF) were presented by Ms Fiona Robertson.

Ms Robertson stated that the BHF was pleased to support the legislation. BHF represents more than one hundred medical schemes in four southern African countries. The industry is in crisis due to excessive growth in medical scheme expenditures, the result of new regulations, an aging population, new technologies, pharmaceutical inflation, etc. The peculiarities of health markets demand government intervention.

As the representative body of medical schemes in southern Africa, BHF is constantly focused on the cost spiral within the private healthcare sector, and efforts to curb it. BHF would therefore like to applaud the government for this Act, as it feels that it will have a positive impact on the private healthcare funding sector, and will go a long way to making this sector accessible to more South Africans.

BHF's submission centres around the following points:

Government should not be excluded from the one exit-price concept. If government is included, it will mean that the playing fields are leveled, which would make for real competition between the private and the public sector when treating patients.

The legislation in terms of regulating dispensing practitioners should be brought in as soon as possible and time lines should be drawn up for the implementation of this.

The legislation in terms of regulating surgicals and consumables should be investigated and implemented as soon as possible.

The pricing committee should contain at least 40% of members from the private sector—perhaps funding sector, hospital sector, and manufacturing sector.

When devising a fixed fee for distribution, cognizance should be taken of the fact that different pharmaceuticals have different transportation needs, i.e. cold storage etc.

The essential drugs list should be expanded to include the formularies used by all medical schemes.

Lists of medication that the respective statutory councils have in principle approved for the various professionals (other than doctors and dentists) when they become legal dispensers should be made available publicly so that benefit structures can be accurately developed.

Would the fact that medical schemes are required, in terms of the proposed regulations, to develop preferred provider networks that are cost efficient, not perhaps put the dispensing practitioners at an unfair advantage in that they would not receive the professional fee which the pharmacy would receive and therefore be able to offer the entire service for less?

Questions and Discussion
Ms Malumise (ANC) asked what transportation needs beyond cold chains existed in the distribution sector.

Ms Robertson (BHF) responded that transport to outlying areas can also be costly.

Ms Kalyan (DP) asked for the BHF's view of removing medical devices from the ambit of the Act. Where could they be regulated?

Ms Robertson expressed her concern around the definition of "medical devices," and the need for their incorporation into legislation. The growth in medical technologies means these devices will become more common.

Ms Dudley (ACDP) noted that BHF urges implementation of the legislation as soon as possible. Does the BHF propose a timetable?

Ms Robertson stated that is was unclear how licensing will rollout, and stated her understanding that 10 000 practitioners cannot be processed through the system in six months.

Presentation by PSSA
The comments of the Pharmaceutical Society of South Africa (PSSA) were presented by I. Kotze.

The PSSA represents 60% of the pharmacists in South Africa. It supports South Africa's national drug policy, and is frustrated by its slow pace of implementation. We do understand some of the reasons for this delay but we find it becoming more difficult to explain to our members and the public why the promised changes have not been forthcoming.

The most important point we want to emphasize today is in response to the recent opposition and threats by dispensing medical practitioners in their efforts to block this legislation.

The following should therefore be noted:

This matter was extensively debated by this committee in 1996 and a report on this matter was published by this committee in November 1996.

This committee recommended four "non-negotiable criteria," these being: (1) Medical practitioners will be allowed to dispense where there are no pharmaceutical services available. This decision will be taken by provincial authorities. The Committee added that underprivileged communities must retain their access to affordable medicines. (2) The prescribed standards for storage and dispensing facilities, which are determined by the MCC, will have to be met before a license to dispense is granted. (3) Prior to receiving a license to dispense, a practitioner would have to certify that he has completed a course in good dispensing practices. Such a course would not have to include an examination and care should be taken to ensure that it is not unduly inconvenient to applicants. (4) The dispensing of medicines, which includes physically handing them out, must be done by the medical practitioner himself.

The NCD argues that additional controls for dispensing doctors are superfluous as existing legislative powers adequately deal with registration and transgression by dispensing practitioners.

The following should be noted:

Existing legislation does not have any penalty clause and a doctor cannot be charged for not registering as a dispensing practitioner i.e. we have legislation with no teeth.

The PSSA submitted many complaints to the HPC and none of these was satisfactorily addressed or addressed at all. In most of these complaints, the practitioners did not dispense the medicines themselves but used laypersons to do this.

The argument that a "one stop shop" for the public is offered by dispensing practitioners is a valid argument for acute medicines only and this must be attended to by allowing a medical practitioner and a pharmacist to practice for their own account from the same premises. This restriction on group practice, that includes pharmacists, forms part of the Health Professions Act, which states that a medical practitioner can only go into a partnership with those professionals registered in terms of the Health Professions Act.

The PSSA understands the reasoning in extending the provisions for a license before a person can dispense medicines from six months to twelve months and supports this amendment. If however the committee feels that the control over dispensing by medical practitioners should be reconsidered, then the PSSA would strongly object to this and requests an opportunity to make a complete submission dealing again with this matter.

We submit that this committee dealt with this adequately in 1996 and should therefore not revisit this matter.

The second matter that needs urgent action deals with technical amendments to the wording of S.22A, as amended by S.13 of Act 90 of 1997.

In our submission to the Department of Health in June 2002 on the proposed bill, we motivated why the word "and" should be added to some subsections. If this is not done, a loophole would exist as the Act could then be read as follows: "A schedule 2, 3, 4, 5, and 6 substance shall not be sold by any person other than a medical practitioner who may prescribe such substance" S.22A(5)(d)(ii). The loophole must be addressed by adding the word "and" in subsections 22A(4)(a)(iii)(aa), 22A(4)(v)(aa), 22A(5)(d)(i), and 22A(5)(f)(i).

The last point in this verbal submission is the wording of S.22A(16)(d). This section provides for the possession of a scheduled substance for a layperson authorized to own a pharmacy. Pharmacies must be registered in terms of the Pharmacy Act and must always be under the control of a pharmacist. It is the pharmacist and not a possible lay owner who may be in possession of scheduled substances. The words "a person licensed to own a pharmacy" must therefore be deleted.

Questions and Discussion
Ms Luthuli (ANC) commented on the difficulty faced by the Committee as it listens to various sides and seeks to adjudicate between interests.

Ms Malumise (ANC) asked why laypersons were sometimes dispensing medicines.

Mr Kotze noted that numerous cases have seen receptionists, secretaries, and even wives of medical practitioners become dispensers. This practice must be ended.

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