IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) Case No: 4183/98 In the matter between: PHARMACEUTICAL MANUFACTURERS’ ASOCIATION OF SOUTH AFRICA AND OTHERS Applicants and THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA AND OTHERS Respondents and TREATMENT ACTION CAMPAIGN (TAC) Amicus Curiae AFFIDAVIT I, the undersigned ALEXANDER MARIUS VAN DEN HEEVER do hereby make oath and say: 1. I am a director at the Centre for Actuarial Research, a research unit within the Department of Actuarial Science at the Faculty of Commerce, University of Cape Town. I am currently on contract co-ordinating the Committee of Inquiry into a Comprehensive System of Social Security and Special Advisor to the Chief Executive Officer of the Office of the Council for Medical Schemes. Over the past five years I have worked on a range of health financing processes and projects while attached to the Centre for Health Policy, University of the Witwatersrand. My curriculum vitae is annexed hereto as annex “AvdH 1”. 2. The facts deposed to in this affidavit are within my personal knowledge except where I indicate otherwise. To the extent that I rely on the information received from others, I believe that such information is true and correct. I respectfully submit that I am by my training and experience duly qualified to express the views and opinions that I express in this affidavit and to access the repute, opinions and reliability of other persons to whom I refer. Overview of Health Markets 3. In order to understand the overall thrust of the health policy of the South African government, a cursory review of various issues relating to specific characteristics of health markets is set out below. 4. In dealing with international trends in health care finance and provision, it is important to note that a high degree of consensus has been achieved regarding the core problems. Although measures to deal with these problems vary across countries, what remains constant is the understanding that government intervention is crucial in achieving key social objectives. 5. Internationally, governments intervene heavily in the financing and provision of health care. The reason for this is well established: because of asymmetric information between buyers (patients) and sellers (such as doctors and hospitals), buyers are vulnerable to over-servicing and over-charging in the absence of government regulation. 6. The standard and almost universal response to this asymmetry of information is to accredit schools in health professions and hospitals, to license health facilities, to introduce codes of ethics, and to place bans on advertising. Instead of relying on markets, the standard response has been to rely on professional norms and self-regulation by healthcare professionals and institutions such as hospitals. 7. Further problems arise as a result of the monopoly power of service providers, such as the raising of prices and the lowering of output and product quality. As a result of (a) services being purchased infrequently, (b) much medical care being of a very technical nature, (c) the emotional state of many patients, and (d) the urgency often required at point of service, information is costly to consumers. The lack of information over the form, amount, and cost of future health care requirements leads to a derived demand for good health, the demand for insurance. This leads to further problems affecting health care costs, services and quality of care. 8. The traditional theory of market failure in health is based on the effect of insurance on incentives. (K. J. Arrow, "Uncertainty and the welfare economics of medical care", American Economic Review, December 1963, pp 941-973). As the incidence of illness and the cost of treatment are uncertain, a risk-averse population takes out insurance. However, once insured people exceed any annual deductible, they face zero costs for any further health care purchases. Consequently insured people will choose to buy more care than they would have if they were paying out-of-pocket. 9. Further, physiciansacting as agents for their patientsrecommend and provide more care. When physicians are reimbursed on a fee-for-service basis, they are given powerful incentives to provide more services than necessary. Increases in per capita expenditure are easily explained by the combination of cost-unconscious demand, more specialists, new technology and new tests. (A. C. Enthoven, "Why managed care has failed to contain healthy costs", Health Affairs, Fall 1993 at 1993, pp 21-43 at 28) 10. Incentives in the health care market are so skewed that the ordinary rules of competition do not work. Prices remain high even when volumes are high. Technology remains expensive even when it is widely used. Hospitals and physicians remain in business even when they charge excessive prices for equal quality or fail to provide high-quality services. Until recently, incentives existed only for innovations that raised costs or increased quality regardless of cost. (E. O. Teisberg, M. E. Porter, G. E. Brown, "Making Competition in Health Care Work", Harvard Business Review, July/August 1994) 11. Publicly financed health care systems remain the backbone of health care financing in most countries. There are basically two approaches to the public financing of health care: the public health service approach (including national health services, which are universal in cover as in the United Kingdom, and public service health systems, which only cover the poorer populations, as in South Africa) and the national/social health insurance approach (which are contributory in nature with the former providing universal cover and the latter providing cover to only the contributors). In the former, the public sector is both the financing agent and the provider of health services. In the latter, the government is the financier but may not be the provider. 12. Indirect financing interventions include two categories of public sector action: financial interventions that affect the cost and availability of various inputs (such as medical personnel, drugs and equipment) in the provision of health care services, and financial interventions that encourage or discourage the provision of certain health care services. 13. The World Health Organisation’s 2000 report provides an important consensus overview of directions in health system values and systems. In particular, the report deals with the benefits that should be targeted by all health systems, the role of governments, the principles to be followed regarding access and equity, and public/private options and opportunities. These issues are reflected in excerpts from the 2000 report, annexed hereto as annex “AvdH2”. Role of Government Intervention in Healthcare Broad Policy Objectives 14. Private markets for health care suffer from inherent destabilising factors which result in: 14.1. systematic cost increases; 14.2. adverse selection (in the case of health insurance); 14.3. provider induced moral hazard (where providers and suppliers of service have a profit motive to supply more services than are actually needed by the patient); and 14.4. consumer related moral hazard (where insured patients face zero cost at point of service they have an incentive to consume services in excess of their actual needs). 15. Many perverse relationships exist within the health care market that result in the provision of services substantially beyond their value to the individual and to society. The resulting cost spiral destabilises the viability of private health care markets. This excessive shift of financial resources into the private environment results in an artificial shift of staff from public to the private sector – and of people in need of health care from the private to the public sector. 16. Private markets for health care traditionally invert normal market behaviour. Whereas demand leads supply in other sectors, the supply of services within the health sector creates demand. It is for this reason that most countries reserve the right to constrain growth in the supply of services in the public interest. In many countries, for example, controls are placed on the creation and deployment of new services and equipment. Although this needs to be done with care, it is by no means unusual within an international context within market driven economies. 17. Where the demand for pharmaceutical products is induced this represents a substantial overhead cost for the economy as a whole, as well as affecting the competitiveness of all companies that provide private health cover for their employees. Bringing down medical costs should thus improve the competitiveness of South African businesses. It will also improve access to necessary and essential pharmaceutical products as in the case of HIV/AIDS. 18. Many countries seek a degree of discretionary power over drug prices and the range of products available on the market. Although direct controls are not always desirable, it should nevertheless remain as one of a range of important instruments that can be used to ensure that drugs remain affordable and that market power is not used unfairly. 19. Government intervention in healthcare is never restricted to one or two instruments, ranging from demand- to supply-side measures in private and public environments. Health policy is never restricted to interventions exclusively within the public sector. This is acknowledged by the World Health organisation's 2000 report (Annexure AvdH 2). 20. Demand-side interventions include the regulation of the funding side of health systems, either through tax-funded systems or through regulated private insurance markets. South Africa has adopted a mixed approach to demandside regulation whereby it intervenes in both environments to remove unfair discrimination, to regulate the perverse incentives of agents (brokers and related intermediaries) and to generate incentives for cost-containment. This is a substantive policy intervention that was introduced through the Medical Schemes Act (No. 131 of 1998), and must be seen together with all other areas of reform. 21. Supply-side market interventions regulate the supply of new technology, increases in the number of beds, the registration and distribution of drugs, increases in the number of new professionals (such as doctors and nurses), price controls and ceilings, marketing practices, pricing practices, dispensing and irregular incentives granted to doctors, pharmacists and hospitals. Such interventions can be used both for specific situations (such as an epidemic) and for controlling perverse practices and the abuse of monopoly power (such as the ability to use unfair market power or collusion to drive prices up). Given that the health market is especially prone to supply-side problems, the regulatory power of government here is regarded as essential, especially where large private health sectors are involved. Large private sectors often lack the balancing (monopsony) effect of a large single purchaser to counter the monopoly/oligopoly power of pharmaceutical vendors. 22. No single measure or instrument on its own is sufficient to deal with the multidimensional nature of a health system. The regulation of the health system involves interventions on publicly and privately provided health services, on both the demand and supply side. Without this approach, major distortions will emerge in one sector that will have a negative impact on the other sector. The Role of Pharmaceutical Regulation 23. In pharmaceuticals, the instruments used to regulate the private sector (for example, manufacturers, distributors and pharmacies) include controls on drug quality (through mandatory inspection programmes), controls on imports (restricting imports of dangerous products or permitting the import of only essential drugs), and registration and licensure of pharmacists. Restrictions on the prices at which pharmaceuticals can be sold have also been widely imposed. 24. In evaluating the impact of regulation, a number of issues need to be considered, including the extent of coverage, the capacity of government to monitor compliance with regulation, the extent of enforcement and exemptions, and the extent to which the private sector can circumvent or evade regulation. 25. The Assessment Guide for Pharmaceutical Policy, annexed hereto as annex “AvdH 3”, indicates that discretion in licensing, marketing and generic substitution are standard instruments for a domestic pharmaceutical policy. (Management Sciences for Health, Managing Drug Supply, Second Edition, Kumarian Press, Boston 1997) Unfair Market Power 26. As already noted, the health market is prone to a number of market distortions that can severely hamper the performance of a health system. One that is fairly typical in the private side of the system is that of unfair market power. 27. Unfair market power can take the form of a single supplier of a good, as in the case of a product under patent or a single government monopoly. This .can be very problematic in the case of essential life-saving/prolonging goods and services. 28. In these instances suppliers of the good are able to charge prices that are in excess of what would be charged in a competitive market. This results in the market distortion termed “super-normal” profits. Such a price is regarded as a market distortion because it is in excess of the socially optimal price -- society as a whole is left worse off. In such circumstances, governments usually regulate prices so that they sit at the socially optimal level. Consumer Protection 29. Consumers are often placed at a disadvantage in situations where there are significant information asymmetries, requiring them to rely on the advice and recommendations of third parties. Consumers cannot inspect every commodity that comes on the market or personally test every product for safety. Great reliance is therefore placed on government authorities and paid intermediaries to assist the ordinary consumer in making certain decisions. 30. Intermediaries, however, are influenced by financial incentives and may be given specific incentives to advise consumers to use preferred goods and services. The central concern here is that the consumer is under the mistaken assumption that they are receiving independent objective advice. The advice given and resulting consumption patterns are not only market distorting, but result in a deviation from the preferences individuals would have expressed if they had full knowledge of all the options. South African Experience of Cost Increases in the Private Sector Overview 31. The year-on-year changes in cost, as opposed to price changes and price levels, is the primary problem facing purchasers of health care. Price is however very important in all countries where a public sector health priority may be involved. HIV/AIDS, malaria and tuberculosis all involve public health servicesin such cases, very high prices could effectively reduce the viability of critical social interventions. Pharmaceutical Cost Increases in the Private Sector 32. Systematic cost increases above general inflation and economic growth are a universal phenomenon in voluntary health insurance environments where services are reimbursed retrospectively on a fee-for-service approach. Although some cost containment is possible through bill reviews and the creation of all-inclusive fees (per diems, global fees or diagnostic related groupers), these have been shown over time to be of limited value. 33. Tables 1 and 2 (attached hereto as annexures “AvdH 4” & “AvdH 5”) show the real changes in total spending on drugs, hospital services and other benefits by South African medical schemes over the period 1974-1999. Overall, drugs have increased in cost by 273% in real terms, while hospital costs have increased by 512.5%. In 1974, per capita drug costs for medical scheme members was R 305. By 1999 this had increased to R 1,137. (Annex “AvdH 5”). The figures for 1997 onward should in fact be higher than they are, but reduce relative to hospital benefits due to a definitional change in the medical scheme statutory return from that year. This results in some medicine expenditure now falling under hospital benefits. There is consequently a discontinuity from previous years. However, after note is taken of the adjustment in 1997 the trend continues as before. In future it will prove more difficult to track pharmaceutical cost increases using medical scheme data due to reductions in the coverage of certain medicines through the use of deductibles and co-payments. This trend has been increasingly evident during the 1990s. 34. Figure 1 (attached hereto as annexure “AvdH 6”) shows real changes in total expenditure by medical schemes on medicines, hospitals and other benefits for the period 1974-1999, with figure 2 (attached hereto as “AvdH 7”) showing real changes in per capita expenditure by medical schemes on medicines and hospitals for the same period. South African Pharmaceutical Policy 35. Figure 3 (attached as “AvdH 8”) provides a representation of the importance to the pharmaceutical industry of uncritical purchasers. The essence of the problem faced by the country at present is a cost problem related to both high prices and the volume of drugs prescribed. 36. Pharmaceutical companies influence the principal decision-maker in the process of selling drugs -- the physician -- through both general and specific incentives to sell. The former occurs because of the percentage mark-up, while the latter occurs when bonuses, discounts and other inducements are used to get doctors to favour particular brand-name products. 37. Virtually all the incentives in the private market induce doctors to prescribe high cost drugs as often as possible. This behaviour permits the pharmaceutical industry to charge higher prices than they would when compared with a normally functioning market. 38. The proposed reforms in the Medicines and Related Substances Control Act focus on addressing various incentives given to doctors to over-prescribe, or to prescribe the drugs from which they receive the greatest profit. Generic substitution, transparent pricing and the outlawing of specific inducements to doctors, if they work, should increase price sensitivity in the market. Response to Arguments Made By the First Applicant in the Answering Affidavit to the Amicus Curiae 39. I have read the Answering Affidavit of the First Applicant. The following are my responses to specific allegations made in that affidavit. 40. In paragraph 5.3 the Applicant asserts that “no saving whatsoever will be brought about in the public sector by the process catered for in section 22F i.e. by generic substitution.” This is mistaken. The situation of the public sector can be greatly enhanced by general cost reductions in the private sector. Generic substitution by its nature is targeted at perverse behaviour and incentives in private fee-for-service markets for healthcare, where doctors dispense. As such any move to remove these perverse incentives should improve access to health services generally through preventing any reductions in medical scheme cover in the private sector. 41. In paragraph 5.4 the Applicants states that there is “no prospect that any saving in the public sector will be brought about by the provisions of section 22G.” This is incorrect. Any removal of perverse incentives in the private sector will impact on funds available in the public sector. Lower costs in the private sector protect medical scheme cover, which indirectly assists the public sector. 42. In paragraph 5.8 the Applicant states that no cost saving will result from generic substitution at the levels of the dispensing doctor, private hospital or clinic. However, it is my belief that the Act would result in a situation where medical schemes, via the retrospective review of bills, would be in a position to ensure compliance with generic substitution in hospital settings. They would also be in a position to set reimbursement rates for drugs consistent with the now transparently priced lowest cost drug on the market. 43. In my view the relevant sections of the Act greatly empower medical schemes to negotiate appropriate prices for drugs – which will result in lower costs. Furthermore, the establishment of the single exit price and the handling fee would in conjunction with mandatory generic substitution substantially improve the ability of the final purchaser to obtain fair prices for drugs in the case of ward stock and hospital dispensaries. 44. In paragraph 5.9 the Applicant asserts that the savings from the measures in the Act will be “small, if any.” This not accepted. They should, if used correctly, have a dramatic impact on prices by moving the system closer to a fair market. 45. In paragraph 6.1 the Applicant asserts that a less restrictive means of permitting generic substitution would require “no more than a law giving an option to the patient to direct the pharmacist to dispense a cheaper generic version of the prescribed medicine; …” . Such a recommendation is unrealistic. It would rely on the unlikely scenario of the typically disempowered and uninformed patient to opt for a generic. This would allow current abuses to continue. 46. In paragraph 6.2 the Applicant again argues that a less restrictive way of preventing perverse incentives would be to target the specific practice, e.g. by prohibiting the doctors and pharmacist from not passing on a discount etc to the patients. However, the suggestion places too much reliance on measures that can be bypassed by indirect means. As argued earlier in this affidavit, the instruments available in the Act must be combined to achieve their maximum effect. 47. At paragraph 9.1.8 the Applicant complains that the single exit price will leave no room for competitive pricing, for discounts or for prompt payment incentives. If a discount were permitted, as argued earlier, this would permit special incentives to be given to doctors or hospitals. The maximum price or ceiling that is preferred by the Applicant would, if set high, merely reproduce the current environment whereby a special volume-related discount off a published price are provided to service providers. For the single exit price to have any meaning, it would clearly have to be the only price. If the PMA recommendation were accepted, it would result in a high ceiling price with discounts. In the case of a single exit price, a lower competitive price would result as manufacturers would have to avoid being over-priced. The market dynamics would be very different to that of a ceiling price. Price factors in the private market 48. The third-party purchaser in the private sector is the medical scheme and is a crucial element in the overall strategic policy picture. The revisions to the Medical Schemes Act (No. 131 of 1998) address many of the perverse elements on the final demand side for pharmaceuticals and other medical goods and services. This element serves to enhance the supply-side reforms. 49. There are essentially two elements driving up volume in the private market for drugs. 50. The first relates to a general incentive given to prescribe higher-priced drugs often, the percentage mark-up. Until now the mark-up has been provided to doctors, pharmacists and hospitals as a dispensing fee, i.e. to cover the cost associated with procuring, storing and dispensing a drug. The mark-up has been reflected as a percentage on a published price (e.g. the “Blue-book” price, namely the price listed in the Ethical Pricing List, published by Pharmaceutical Publishers and Printers). The final purchaser, the patient, pays a price which includes this mark-up. As the medical scheme is reimbursing or directly paying for the drug in the private sector, the patient is not very price sensitive. Even if they were concerned about the price, they are not in a position to question the decision of the doctor. The general mark-up therefore creates a powerful incentive to increase the volume of drugs prescribed and to prefer the higher-priced drugs. 51. The second element involves specific incentives targeted at doctors responsible for both prescribing and dispensing. These specific incentives are additional to the general incentive and are used to create preferences for specific companies or brand names. Incentives take the form of: 51.1. Bonusing: this is essentially a direct financial kick-back in exchange for proof of volumes prescribed and dispensed – the extent of the bonus is linked to target volumes; 51.2. Discounts of the published price (this substantially increases the impact of any percentage mark-up); 51.3. Formularies: doctor groupings such as Independent Practitioner Associations (IPAs) create limited drug lists. Pharmaceutical companies essentially have to pay a “fee” to get on the formulary. Limited lists used by the final purchaser are usually quite beneficial for cost management. However, when used by the agent (i.e. the doctor) they are used to “pressurise” pharmaceutical companies for additional compensation. 52. When these elements are combined with a price insensitive final purchaser, the market will be faced with general price and volume increases beyond what is actually needed and high prices (due to the preference created for high price drugs). 53. As the mechanisms causing the eventual cost increases (price x volume) result from a combination of perverse elements, market corrections are required through a combination of instruments. No single measure is sufficient on its own. Policy instruments: 54. The various measures described below, which are in my opinion rational and reasonable, are part of the overall policy package introduced by the Medicines and Related Substances Control Amendment Act Although I am aware that the amicus curiae has sought permission only to defend Sections 15C, 22F and 22G of the Act, it is important to see these measures in their context. 55. The general mark-up: The appropriate response here is to move to a flat-rate dispensing fee rather than a percentage mark-up. However, without addressing the specific incentives given by pharmaceutical companies to agents, very little will be achieved by this measure on its own. 56. Specific incentives: These are dealt with through: 56.1. Outlawing of bonusing and discounting: On its own however, these measures are not sufficient, as there are too many ways that kick-backs of one form or another can be given, both directly and indirectly. 56.2. Transparent pricing from manufacturer to final purchaser: This measure can assist in making all market participants aware of the prices and mark-ups being paid from the manufacturer to the final purchaser. However, although this measure is useful, it will achieve little when the purchasing decisions are controlled by agents receiving kick-backs. 56.3. Mandatory generic prescribing: This breaks the crucial link between the act of prescribing and dispensing – greatly disrupting the ability of the pharmaceutical manufacturer to incentivise a chosen agent. This is one of the central measures that begin to address the core problem of specific incentives to agents. 56.4. Single exit price: This eliminates specific discount-related incentives being provided to agents. It therefore removes an important perverse incentive. 56.5. Elimination of the dispensing doctor: This measure, in conjunction with mandatory generic prescribing by pharmacists, breaks a number of critical collusive arrangements, making it far more difficult to co-ordinate the allocation of specific incentives as easily as before. 57. The measures described above achieve a number of rational objectives in relation to overall health policy: 57.1. The general trend in the cost of drugs can be addressed, reducing the cost of private medical scheme cover and preventing a drop out of membership on to health services provided by the state. 57.2. Basic consumer protection is enhanced through removing incentives to prescribe drugs that are either not needed or may even be harmful to members of the public. Mandatory Generic Substitution 58. Mandatory generic substitution is criticised by the first applicant on a range of grounds. Some responses to questions raised by the PMA and its consultants are provided below. 59. Why are pharmaceuticals treated differently from other commodities where it would be regarded as abnormal behaviour for a substitution to occur? 60. The purchase of pharmaceuticals has an agent interposed between the product and the final purchaser, unlike in the case where clothing or a television set is purchased. In the former instance the product that is being purchased is “good health care”, which includes the pharmaceuticals purchased. Here the patient is concerned about the outcome only and the brand name of a product attracts no loyalty. A problem exists for the patient, however, in that the health care is purchased in a time of need and with a limited opportunity to shop around. 61. In the case of an ordinary commodity, taste and personal preference play an important role in the choice of whether and what to buy. This ceases to be the case in all situations where an agent with substantial influence over the final demand for goods and services is interposed. In ordinary markets the purchase is not driven by an acute need and an opportunity to shop around and to review alternative products can occur. If the consumer wishes to trade- off a higher price against a specific preference for a product with a particular characteristic, e.g. colour or quality, then this can occur through delaying the purchase of other products or by dipping into savings, by saving or by taking a loan. 62. Health care is often purchased through some form of insurance in the private market. However, health insurance also reduces the incentive of the consumer to review the purchase. Many health care providers take advantage of this fact, within a fee-for-service environment, to provide services or prescribe in excess of the needs of patients for personal gain. Over time this creates a market driven by what is termed “supplier induced demand”. Ultimately this results in systematic cost increases which are difficult for individual purchasers of health care to adequately contain. 63. Within private markets the following considerations over-and-above price need to be taken into account: 63.1. The drug bill of any medical scheme is based on both the price and the volume of drugs dispensed or used. Volumes may accelerate if prices are contained. 63.2. Year-on-year changes in price are often more important than the price level in any one year. The freedom to increase prices substantially above the general inflation rate is often an indication that the market is not adequately responding to price signals. The implication is that some form of collusive arrangement (or other market imperfection) is occurring such that the consumer is not adequately empowered, through normal market forces, to force prices down to competitive levels. 63.3. Year-on-year changes in the overall cost of medicines are a clear indication that the primary agent determining the drug purchase of the patient is profiting from additional sales. The doctor is able to control the volume of sales, as well as the final price of the drug. The doctor profits from both. Clearly a collusive arrangement between the manufacturer and the doctor will cause a problem here, and often does. 64. Within properly functioning markets, pharmaceutical manufacturers will have to price their products more competitively. They will also face a market in which incentives to induce additional volume may be reduced. Both these influences will probably force uncompetitive products off the market. Consequently, manufacturers with limited justification for survival will drop out of the picture – as is the situation within normal markets. Parallel Importation 65. It is generally accepted as normal market behaviour to attempt to purchase the lowest cost equivalent drug on the market. If the public sector remains restricted to domestic suppliers, this fundamental principle of normal market behaviour cannot be observed. Aside from the issue of quality control (which is addressed through other measures), there is no market-related reason to prevent the introduction of parallel importation. As a measure for eliminating the effects of market segmentation (price discrimination) in the purchasing of essential drugs it is clearly an essential measure. Single-Exit Price 66. Provided here are some responses to comments that have been made by the PMA and one of their consultants, Prof. Duncan Reekie. The responses to these arguments are important in illustrating why the reforms are important instruments of public policy. 67. According to material filed by the Applicant: “Uniform price legislation would make it illegal to negotiate discounts on prescription medicine (other than for volume) with retailers who can offer services to manufacturers that justify discounts. Uniform prices should be opposed as a form of price control. They are inconsistent with the goal of strengthening competition in the private health sector and would curtail company pricing flexibility - a flexibility which has been important in causing reductions in ex-factory price levels in recent years, and which, in turn, despite many artificial rigidities in the distribution chain, has resulted in lower prices paid by patients to many previously unavailable forms of medicine distribution (for example mail order pharmacies, dispensing doctors and preferred provider pharmacies nominated by medical schemes). Conventional retail pharmacies, leading proponents of uniform pricing, consequently now find it essential to offer discounts to their customers.” (Reekie) (PMA, 1997) 68. Reekie fails to note that the final consumer of medical services has faced no real reduction in cost. Consequently, the value of price flexibility in reducing the final cost of drugs must be questioned as ex-manufacturer price flexibility has existed over all the years in which costs have been rising. 69. Furthermore, discounts within the market for medicines rarely result in lower costs for the final purchaser. In fact none of the discounts on offer have that as a final objective. In those instances where a pharmacist offers a discount to a patient, this is frequently at the expense of a medical scheme. For instance, the pharmacist offers the patient a discount on a drug which is fully covered by a medical scheme. However, the patient is allowed to claim from the medical scheme at the full price, with the assistance of the pharmacist, and keep the difference. This discount is used by the pharmacist to provide an incentive for the patient not to use a dispensing doctor, or to create a preference for a particular pharmacy. The discount is not genuine and is fraud, i.e. the claim from the medical scheme is more than the actual charge. Discounts have however primarily been used as incentives for increased prescribing of particular drugs. 70. “Secret rebates do not remain secret for long and any rebate is soon matched. This is how competition avoids prices congealing at high levels. (Reekie) (PMA, 1997) 71. Rebates within the health market are common and very confidential. These rebates do not result in lower prices for the final purchaser, irrespective of whether or not they remain secret. 72. “The price difference between the two sectors, in effect, if not in intent, results in a redistribution of income.” (Joan Robinson, 1933) (Quoted by Reekie) (PMA, 1997) 73. Price discrimination allows the supplier to capture a greater portion of the consumer surplus than would be the case with a single price. Rather than being a “redistribution of income”, the measure if introduced prevents these socially sub-optimal transfers to producers. 74. The creation of a transparent single exit price reduces the ability of the supplier to use price as a form of market manipulation. 75. Individual price comparisons between particular medicines today, versus the same a few years on, will not reflect the above behaviour. This is because the medicines upon which providers were maximising profits a few years ago, may not be the same now. These would change depending upon the specific incentives applied to specific medicines provided at any one point in time. Some medicine prices may even go down. However, costs will increase as the focus remains on the highest priced medicines and keeping the number of items per script high. 76. “... the fact that distribution costs in South Africa are among the world’s highest. Or to put it another way, South African manufacturers receive among the world’s lowest percentage of the final selling price of medicine.” (PMA, 1997). 77. Reekie places strong emphasis on the price impact of inefficient distribution chains within the pharmaceutical market. However, one of the primary reasons for the high prices of medicines involves the manipulation of the final purchaser, and the incentives given to do so. The high cost distribution chain could explain why medicines are generally expensive, but it cannot explain the annual real cost increases that are evident in the market. Consequently the distribution chain cannot be seen as the primary cause of high medicine prices. Savings from improving efficiencies in the distribution chain will only result in a one-off reduction in the cost to the retailer or dispensing doctor. This one-off saving need not be passed on to the patient and historical cost increases could remain unaffected. Conclusion 78. On the basis of all the above I submit that sections 15c, 22F and 22G are rational measures, anticipated by national and international health policy, that have the legitimate and likely objective of reducing the price of essential medicines in the South African private and public health care sectors. ________________________ DEPONENT SIGNED AND SWORN TO BEFORE ME AT JOHANNESBURG ON THIS THE 10TH DAY OF APRIL 2001, THE DEPONENT HAVING ACKNOWLEDGED THAT HE KNOWS AND UNDERSTANDS THE CONTENTS OF THIS AFFIDAVIT, THAT HE HAS NO OBJECTION TO TAKING THE PRESCRIBED OATH AND THAT HE CONSIDERS THE SAME AS BINDING ON HIS CONSCIENCE. ________________________ COMMISSIONER OF OATHS