Investigation Reports

PUBLIC PROTECTOR
REPUBLIC OF SOUTH AFRICA


REPORT IN TERMS OF SECTION 8(2) OF THE PUBLIC PROTECTOR ACT, 1994

REPORT NO 6
(SPECIAL REPORT)

REPORT ON THE PROPRIETY OF THE CONDUCT OF MEMBERS OF THE MINISTRY AND DEPARTMENT OF HEALTH RELATING TO STATEMENTS IN CONNECTION WITH THE PRICES OF MEDICINES AND UTILISATION OF GENERIC MEDICINES IN SOUTH AFRICA

1. INTRODUCTION

The Pharmaceutical Manufacturers' Association of South Africa (PMA),through its Chief Executive Officer, Ms Mirryena Thereza Deeb, submitted a complaint to me on 27 June 1997 requesting an investigation into the conduct of certain officials of the Department of Health from whom certain allegedly "offending statements" against the Pharmaceutical Manufacturers' Association emanated.

Each of the "offending statements" is an excerpt from newspaper articles published in several different newspapers.

The PMA maintains that the making of these statements have been improper in "that it failed to comply with accepted standards for public administration, more particularly, but not exclusively, in that it failed to meet the basic values and principles governing public administration as set out in Section 195(1) of the Constitution which, inter alla, provides that:

'Public administration must be governed by the democratic values and principles enshrined in the Constitution, including the following principles:

(a) A high standard of professional ethics must be promoted and maintained.

(b) Transparency must be fostered by providing the public with timely, accessible and accurate information. "'

2. THE COMPLAINT:

2.1 The "offending statements',

2.2.1 Offending statement l:

"South Africa (is) rated in the top five most expensive countries in the world for medicine. "

2.2.2 Offending statement II:

"Some medicines sell in South Africa for up to 4000% above the world average. "

2.2.3 Offending statement III:

"South Africa pays, for example, 2500% more for anti-tapeworm preparationsthan the international norm. "

2.2.4 Offending statement IV:

"Medicine cost have increased at double the inflation rate over the past 10years. '

2.2.5 Offending statement V:

"Prescription of generic medicine in South Africa, at 16 percent, lagged behind that in countries like the United States at 48 percent, and Britain, at 54 percent.

The PMA is of the opinion that the making of these offending statements has created a perception in the minds of the general public that medicines in South Africa are unreasonably expensive and moreover that the blame for such expensive medicines lies with the manufacturing and primary importing companies. This they feel has resulted in impropriety or prejudice to members of the PMA, and they also maintain that they are further threatened to be prejudiced or to be subject to impropriety in that certain legislative measures are proposed to be introduced by the Minister of Health which, if implemented, would materially detrimentally affect the business of members of the PMA, and as a result also the livelihoods of thousands of their employees. The PMA suggests that the proposed legislative measures (Medicines and Related Substances Control Amendment Bill [B72/97]) were introduced by the Minister on the premise that medicine prices are unreasonably high compared to world prices. It was further submitted by the PMA that some of the proposed measures by the Minister of Health are likely to result in potential prejudice to the public at large.

2.2 Request:

I was then requested by the PMA to investigate the conduct of the responsible officials involved in the compilation, formulation, dissemination and/or making of the offending statements and to establish whether such conduct was indeed improper or likely to result in any impropriety or prejudice to members of the PMA or others and to report thereon.

3. THE INVESTIGATION:

3.1 Background:

After studying the extensive complaint documentation submitted by the PMA, I decided to investigate the complaint and on 11 July 1997, I wrote to the Minister of Health, Dr NCD Zuma, informing her of the complaint received and requesting her to comment on the allegations made.

I received the Ministry of Health's formal response on the complaint on 18 August 1997.

3.2 Designations:

After submitting the complaint to the Minister of Health, I decided to appoint, in terms of section 7(3)(b) of the Public Protector Act, 1994, certain experts in the field of medicine and more particularly pharmacology, to assist me in this investigation with their specialist knowledge and experience. Although we seem to have a wealth of authorities in this field in South Africa, it was extremely difficult to find anyone who is not directly or indirectly connected to either the Department of Health or the Manufacturing Industry. Ultimately, I utilised the expertise of four authorities in this field, three of whom I would describe as largely independent. They are:

Prof J V Van der Merwe; emeritus-dean of the University of Pretoria, currently Director: Professional Affairs, Healthcare Management Services (HMS);

Dr L Walters; Clinical Director, Pharmaceutical Benefit Management and professor of Pharmacology, University of Cape Town;

Dr J R Cowlin; Managing Director, Pharmaceutical Benefit Management; and

Prof K P Mokhobo; Head of Medicine. MEDUNSA.

3.3 Assessing the complaint:

3.3.1 HISTORICAL BACKGROUND:

In assessing the complaint, it is important to understand the role of both the Pharmaceutical Industry and the Department of Health in the health industry in South Africa today. Cognisance also has to be taken of the difference in the private and public healthcare markets.

3.3.1.a The Department of Health:

Section 27(1) of the Constitution reads: "Everyone has the right to have access to -(a) health care services, including reproductive health care;.. ".

In 1994 the Minister of Health established a National Drug Policy Committee and on the basis of the Committee's report, workshops and discussions held with key role players, a National Drug Policy (NDP) was developed. The goal of the NDP is to "...ensure an adequate and reliable supply of safe, cost-effective drugs of acceptable quality to all citizens of South Africa and the rational use of drugs by prescribers, dispensers and consumers." More specifically, the objectives of the NDP are as follows:

"(A) Health objectives:

  • to ensure the availability and accessibility of essential drugs to all citizens
  • to ensure the safety, efficacy and quality of drugs
  • to ensure good dispensing and prescribing practices
  • to promote the rational use of drugs by prescribers, dispensers and patients through provision of the necessary training, education and information
  • to promote the concept of individual responsibility for health, preventive care and informed decision making.

(B) Economic objectives:

  • to lower the cost of drugs in both the private and public sectors
  • to promote the cost-effective and rational use of drugs
  • to establish a complementary partnership between Government bodies and private providers in the pharmaceutical sector
  • to optimise the use of scarce resources through co-operation with international and regional agencies

(C) National development objectives

  • to improve the knowledge, efficiency and management skills of pharmaceutical personnel to re-orientate medical, paramedical and pharmaceutical education towards. the principles underlying the National Drug Policy
  • to support the development of the local pharmaceutical industry and the local production of essential drugs
  • to promote the acquisition, documentation and sharing of knowledge and experience through the establishment of advisory groups in rational drug use, pharmacoeconomics and other areas of the pharmaceutical sector."

Measures introduced by the Minister of Health should thus be seen against this background.

3.3.1.b The Pharmaceutical Manufacturers' Association

The PMA is an Association incorporated under Section 21 of the Companies Act, 1973, whose membership comprise mainly bodies corporate carrying on business in the Republic of South Africa as manufacturers or primary importers of medicines which are promoted mainly to the medical, dental, nursing and pharmaceutical professions.

According to the PMA, they are responsible for about 90Yo of the value of sales of pharmaceutical products by manufacturers and primary importers of medicines in South Africa. The pharmaceutical industry has played a significant role in combating and preventing disease and ailments. It can even be said that breakthroughs by the pharmaceutical industry, for instance, anti-infective agents, anti-hypertensive drugs etc... made a significant difference to the well-being and survival of millions of people, nationally and internationally. Furthermore, research and breakthroughs are still at the order of the day, occurring at regular intervals with beneficial effects to the health of the population. The pharmaceutical industry also makes a significant contribution to stimulate and financially support research, not only at Universities and Academic Hospitals but also in the private sector.

3.3.1.c Price Discrimination

In South Africa, two distinctly separate markets for Pharmaceuticals exist, namely the private health care market and the public market.

In the public market, pharmaceuticals are purchased in the COMED (the public sector co-ordinating body for procurement) system in bulk.

Pharmaceutical manufacturers, like sellers of any product to two different market segments with differing price sensitivities, accordingly price more highly in the less price sensitive sector (private market), and at a lower level in the more price sensitive sector (public market). This is sometimes referred to as spontaneous price discrimination.

The state purchases nearly 80% of all prescription medicines (volume) although in terms of value (rend and cent) this is approximately 34% of the national pharmaceutical market.

3.3.2 DEFINITIONS:

The term generic is used in a number of different ways by the pharmaceutical industry and its commentators. Indeed, the World Health Organisation (WHO) prefers not to use the term generic if it can be avoided. The preferred name for the WHO, is a multi-source pharmaceutical.

Where generic must be used, it usually means a pharmaceutical product, intended to be interchangeable with an innovator product, which is commonly manufactured without license from the innovating company, and marketed after expiry of patent or other exclusivity rights. Generic products may be marketed either under the nonproprietary approved name or under a new brand (proprietary) name. They may sometimes be marketed in dosage forms and/or strengths which differ from those of the innovator product.

Life stages of a Pharmaceutical Product.

Single source pharmaceutical:

This stage only applies to innovative new pharmaceutical products that have been approved for marketing. These products will usually have regulatory or patent derived exclusivity for marketing, lasting for a period of anything up to 20 years, (15 in the US). There can be only one version of the drug on the market in any particular country, as regulators will refuse to approve further versions for marketing until the period of exclusivity expires. The manufacturer can set any price it likes, and is only open to competition from alternative treatments for the same disease. If the product is unique, it has a guaranteed monopoly for the period of its patent or regulatory exclusivity.

These products are often called brand-name products, as they are marketed under a particular name. Similarly, the manufacturer of such products is called a brand-name manufacturer.

Multi source pharmaceutical:

There are two parts to the definition of a multi-source pharmaceutical, which depend on the product history.

a) Multi-source branded product. When a single source product loses its patent protection it becomes open to competition, in that any other manufacturer can make the drug without infringing on its patent or regulatory exclusivity. What will usually happen is that the branded drug will continue to be sold as a branded product, with other drugs coming on the market as competition (as mentioned in par. 3.3.2, the competition may sometimes be marketed in dosage forms and/or strengths which differ from those of the innovator product.) Where these other drugs are sold as brand names, with the implicit marketing push it requires, they are known as multi-source branded drugs as well. That a drug loses its patent and becomes multi-source does not require that there is real generic competition, merely that the possibility is there.

b) Generic drugs. The true generic drug is a copy of a once-patented product that has now lost protection. The generic drug will not have the same marketing effort applied to it as will the branded products, whether single- or multi-source. It is this side of the definition of multi-source pharmaceuticals that is used when talking about generic competition or generic substitution. It is common to use the term generic pharmaceutical to refer to multi-source products as a whole.

3.3.3 EVALUATION OF THE OFFENDING STATEMENTS:

3.3.3.(i) Offending Statement 1:

"South Africa (is) rated in the top five most expensive countries in the world for medicine. "

This statement was quoted from an article which appeared in the Cape Argus of 21 March 1997 (as well as other newspapers) under the heading: "Zuma ready for battle to end drug profiteering". The PMA submitted the articles which appeared in the Newspapers to a Mr Marius Fourie of the Department of Health for comment and substantiation of the allegation made in the press. Mr Fourie then responded in a letter signed on behalf of the Director-General of Health (copies of which he sent to the Saturday Star and Sowetan Newspapers). In his response Mr Fourie explained that the Department made use of the so-called IDA-Price Indicator (i.e. the IDA is a non-profit organisation which distributes essential drugs at reduced prices to the public sector of many developing countries), the Multi-National Pharmaceuticals updated price lists as well as the MIMS Generic/Trade Name Index (November/January 1996 -1997). The sample of drugs compared involved drugs appearing on the Essential Drug List (1996). According to Mr Fourie's calculations several examples of multi-national prices exceeding the IDA prices by more than 4000%, were found.

The PMA argues that it is inappropriate to use the IDA price indicator as a comparison base, since the IDA is a non-profit charity which distributes essential drugs at reduced prices to the public sector in developing countries. Furthermore, it is argued that the IDA price indicators would appear to have been used to construct a price index for 46 essential drugs consumed in developing countries and should not be validly used for any statement which relates to all countries of the world and to all pharmaceutical products. It was also claimed by the PMA that Mr Fourie not only made incorrect calculations in his letter but that that his comparisons were misleading since he simply multiplied the small pack size price, by the multiple by which the IDA packs exceed the local packs, and presented that as the South African price -whilst the PMA maintains that larger packs sell at substantial discounts. It was also stated that he compared prices applicable to the South Africanpnvate market to IDA price indicators which relate topublic sector prices in developing countries.

The Department responded by admitting that this statement was made on behalf of the Department. The Minister furthermore acceded that a comparison between the SA private sector prices and IDA prices is inappropriate. She also said that it was unfortunate that the letter which was sent to the PMA (and 2 news papers) by an official of the Department, Mr Fourie, on behalf of the Director General, contained inaccurate information and an improper comparison. Apparently the letter was sent to the PMA without the necessary authorisation.

The Minister then states that she stands by the statement that South Africa is rated in the top 5 most expensive countries in the world for medicine, as "we believe it is true."

In support of this statement the Minister referred me to a presentation by D G Boyce made at a Pharmaceutical Forum Conference entitled "Curtailing the Cost of Medicines in the Private Sector", wherein he claimed that South Africa is number 4 behind the Netherlands, USA and Germany in terms of drug prices.

The Minister also referred me to the Competition Board report 52, 1996, p7 wherein it is stated that "medicine's costs in the private sector are proportionately very high by world standards".

Thirdly, I was referred to a letter of the Representative Association of Medical Schemes (RAMS), dated 18 February 1997, where it is stated that drug expenditure as a percentage of total health expenditure in South Africa's medical aid industry has been reported to have risen in recent years from 26% and is expected to reach 33% in 1997. This is substantially higher than the figures for most developed countries such as the USA and the UK, which range from 8 to 12%.

Fourthly, the Minister referred to the UK based pharmaceutical journal SCRIP to support the "offending" statement. This journal reported on 20 December 1994 that "For most multi-national companies, the South African market is one of the more profitable - drug prices in the private sector are among the highest in the world."

The Minister furthermore stated that the quoted press articles referred to the cost of medicine (which she says is price x utilisation) whereas the PMA based its complaint on pure price comparisons.

Finding:

A "factual" statement like South Africa being in the top 5 most expensive countries in the world, certainly needs convincing data as back up.

  • The IDA is a non-profit organisation which distributes essential drugs at reduced prices to the public sector of many developing countries, and as such might be an inappropriate source of information regarding foreign drug prices to compare with South African prices. This may be the case given the fact of South Africa having a partly first-world and partly third world component. Although the Department repudiated the letter sent by the official Mr Marius Fourie, he did sent the letter to the two news papers on behalf of the Director General whilst failing to ensure the veracity and accuracy of his statements.
  • The Conference Paper by DG Boyce was presented at a local "pharmaceutical forum" which took place in 1992, and therefor could possibly reflect dated data. No sources or references substantiate the claims in Boyce's paper. Boyce's statistics only cover 13 countries and is silent on the number of pharmaceuticals included. He also only considered the private market.
  • The quoted press articles did not clearly refer to cost or total expenditure, but toprice.
  • T he various documents presented by the Minister in order to substantiate the offending statement failed to do so.

The debate around the prices of Medicine in South Africa has been robust and it is not easy to draw in black and white terms or in a point scoring method, the accuracy of the numerous sources and statistics that are referred to. The statistics that may have been drawn a few years back depending on accuracy and integrity of the process in terms of which they were produced, may still have relevance. On the other hand, circumstances may have changed and they may be totally dated and irrelevant. It is accordingly not possible to say that the Minister of Health was able or unable to prove or substantiate the statement that South Africa could be rated in the top five most expensive countries in the world for medicine. It could be argued, as the PMA does, that the contrary is true. Nevertheless, it can be deducted that pharmaceutical profits are substantial in this country; that the cost and price of pharmaceuticals in South Africa is high; and of the premium rend available for healthcare the amount spent on medicine, is nearly double to triple that of other major countries.

3.3.3.(ii) Offending Statement 2:

"Some medicines sell in South Africa for up to 4000% above the world average "

The alleged offending statement appeared in an article in the Cape Argus News paper of 21 March 1997, and was repeated in other news papers. Following the enquiry which the PMA made with Mr Marius Fourie of the Department of Health and his response thereto that the IDA index was used to make the comparisons, the CEO of PMA, Ms Deeb met with the Minister of Health during a public function and told the Minister that she believed that the allegations that some South African pharmaceuticals are 4000% more expensive than the world average was based on unscientific comparisons. The Minister's response was that the price differences were irrelevant since she believed South Africa's prices were among the five highest in the world. The exchange between the Minister and Ms Deeb was reported in the Star News paper of 15 April 1997.

The PMA is of the opinion that the Department of Health will not be able to substantiate the Offending statement 2 as being accurate and furthermore that the PMA is being slated because of the wrong perceptions created by the Department of Health. In a media release by the Department of Health (dated 26 June 1997) it was said that the "PMA is only interested in maximising profits for it's members with little regard for peoples' lives."

The Department responded to me by admitting that the statement was made on behalf of the Department. "The Department did a recalculation and found out that the correct figure was in fact 2515%". The Department however now stated that the comparison was not based on IDA as against SA private sector prices, but was based on COMED tender prices as against IDA/UNICEF prices, as they were in November 1 996.

Finding:

The 4000% by which South African medicines was allegedly more expensive than the world average, was by the Minister's own admission based on an erroneous calculation. The Department concede that on re-calculation it was 2515%.

From what the Minister submitted to me, this figure is apparently based on comparing the price of one pharmaceutical, (anti-tapeworm drug), through COMED tender prices as against UNICEF (UNICEF is a charity, focusing on the youth, women and children) prices.

Thus, it seems, the offending statement 2 that "some medicines sell in SA for up to 4000% above the world average", is based on the price difference of one drug.

Furthermore, upon investigation, it came to my attention that UNICEF is (like the IDA) a charity, focusing on the youth, women and children. Whilst both UNICEF and IDA are both organisations which operate within certain specified parameters with particular groups in the world community as their targets. In that context it would be inaccurate to use them to calculate a world average price. In any event, with regard to offending statement 2, the Minister of Health by her own admission concedes that the correct figure was far less than the 4000% quoted and closer to 2515%. It becomes quite clear therefor that the information disseminated was grossly exaggerated.

3.3.3.(iii) Offending statement 3:

South Africa pays, for example, 2500% more for anti-tapeworm preparations ...than the international norm. "

The quoted statement is a translation of a statement published in Afrikaans in the Beeld Newspaper of 20 June 1997 and attributed to Dr Jones of the Department of Health. The PMA is of the opinion that this offending statement is particularly inexcusable for the fact that it was made after the Minister and the Department had taken time to study the PMA submissions to the parliamentary Portfolio Committee on Health. It is argued by the PMA that the making of the offending statement by Dr Jones constituted improper conduct if indeed his statement was based on the IDA prices or indices.

The Department responded to me by saying that the statement was indeed made by Mr Jones in the presence of officials of the Department. "The Department agrees with the statement made. In fact the Department contends that the correct figure is 2515%, i.e. 15% more than the figure quoted by the complainant." It is once again stated by the Department that COMED and UNICEF prices were used. "COMED buys 100 niclosamide tablets (used for tapeworm) from Bayer SA for R349,51. An equivalent quantity of tablets can be bought from UNICEF for USD 2.13. With 6% costs, 20% transport and 14% VAT added, the resulting landed price in SA would be R13,90. This means that COMED buys at 25 times the UNICEF cost."

Finding:

Supposing, one could argue that UNICEF could be "an international norm" for these type of preparations, then it appears as if the statement by Mr Jones, in the presence of other officials of the Department, has not been improper, although it is misleading.

In conclusion, offending statement 3 made on behalf of the Department is found not to be improper.

3.3.3.(iv) Offending statement 4:

"Medicine costs have increased at double the inflation rate over the past IO years."

This statement is a quotation from the editor's column which appeared in the Business Day on 27 May 1997 where it is stated to be an estimation "by some" and in which pharmaceutical manufacturers are blamed for offering no solution for the spiralling costs. The PMA submitted that the offending statement 4 is wrong insofar as it relates to manufacturers' prices. The complainant then gives percentage increases in prices of schedule 3 and higher scheduled medicines sold in the private sector by the top 75 manufacturers and primary importers over the last 10 years. This has been measured by the so-called Laspeyres and Paasche Indices, which are based on different models for assessing the increases of costs of medicines at manufacturer's or product originator level.

The complainant also compares the percentage increases to the Consumer Price Index over the same decade and there seems to be no statistical difference. The complainant rejects the statement that "medicine costs have increased at double the inflation rate over the past 10 years."

The Department responded to me by saying that the offending statement cannot be attributed to anyone in the Department. "The media independently express its views on topical issues in editorials, based on their own research and investigations."

Finding:

The evidence as offered by the PMA refers to manufacturer's prices. The editorial states: " they offer no solution to spiralling medicine costs which, some estimate, have increased at double the inflation rate over the past 10 years."

In conclusion, no evidence has been submitted to implicate any official of the Department and therefore the Minister's statement to the effect that offending statement 4 has nothing to do with the Department is correct.

3.3.3.(v) Offending statement 5:

"Prescription of generic medicine in South Africa, at 16 percent lagged behind that it countries like the United States, at 48 percent, and Britain at 54 percent. "

The quoted statement is again from the Cape Argus article dated 21 March 1997. In a statement which is more or less to the same effect as that quoted above was made by Dr Roberts, Advisor to the Minister of Health in an article published in SCRIP magazine of June 1997. In this article Dr Roberts alleged that " In the private market, generics account for 35~o of the market in terms of units, (15% by value) whereas in the UK almost 60% of prescribed drugs are generics." Furthermore the Minister in her address to Parliament on 11 June 1997 placed generics use in the USA at 40% (on this occasion), a figure that was repeated by Mr Hlongwane of the Department in his media release dated 26 June 1997.

The PMA also quotes statistics that the rend value of generic usage in the private sector at end December 1996 was 18,6% and the volume share was 26,4%. It then reconciles the state sectors contribution with that of the private sector and comes to the conclusion the SA's generic usage is 40% or higher by volume and at 19% by value, based on (according to the complainant) a very conservative estimate.

The PMA also referred me to the Financial Times report by A Southwood entitled "Generic pharmaceuticals - 1996 edition" This article estimates the value share of generic products in the USA and UK in 1995, were ll'%o and 15% respectively and in volume terms, generic products were estimated to enjoy 40% in both the US and the UK.

The PMA furthermore points out an inconsistency in data, whereby Dr Roberts in his article incorrectly compares the proportionate sizes (volume/value) of the SA generics markets share, relative to that of the UK. The UK figure however relates to prescribed drugs and since generic prescribing is not equivalent to generic dispensing, the comparison is invalid.

The Department responded by admitting that the statement was made on behalf of the Department. The Department states that the figures in respect of the UK are correct, but that the correct figure with regard to the USA is in fact 40%. The Department however now states that "The correct prescribing figure for South Africa is not known; the closest comparison would be the 'volume into' which is estimated at 22 - 27C7o, depending on the source. The conclusion of the Department that South Africa lags behind UK and USA remains, however, valid."

Finding:

In the offending statement the percentage figures are not comparable because:

(a) the 16% refers to the market value - since the prescribing figure in South Africa is not known;

(b) the 48% (USA) and 54% (UK) refers to market volume.

The figures used by the Minister however, was not accompanied by any proof. Could it be accepted that although generic prescribing takes place for example in the UK, that generic dispensing does necessarily follow suit?

During this investigation it became clear to me that it is difficult to compare the equivalents in the generics markets internationally. The generics share of the total market by volume percent is 40% for Germany, UK and USA (source: Datamonitor, 1995). The SA counterpart is difficult to establish - Roberts says 35% in his article and the PMA suggests between 26,4% and 41,8% (according to their calculations). The Department indicates between 22 - 27%. Comparing value share could be used as a possible yardstick for accuracy of volume estimates. According to Datamonitor and IMS, the generic share of total market by value is the following:

UK 15%
USA 11%
Germany 30%
South Africa 17%.

Thus, South Africa seems to not lag significantly behind these countries In conclusion, the information contained in offending statement 5 is could be misleading, but is not found to be improper.

4. CONCLUSION:

The Pharmaceutical Manufacturers' Association is correct in expecting from the Minister of Health to provide the public with "...timely, accessible and accurate information" as prescribed by Section 195(1) of the Constitution. It can also be expected that someone appointed in the position of national Minister of Health should ensure that a high standard of professional ethics be promoted and maintained in the administration of her Department. It is evident from my investigation that the information supplied by the Department of Health on the issues relating to the prices of medicines and utilisation of generic medicines in South Africa, has (on the Minister's own admission) sometimes not been as accurate as could be expected.

However, perhaps one should also take cognizance of section 16(1) of the Constitution, which refers to freedom of expression and more specifically:

"Everyone has the right ot freedom of expression, which includes -

(a) freedom of the press and other media;

(b) freedom to receive or impart information or ideas;

...

(d) academic freedom andireedom of scientific research. "

A sizeable "clash" between the Minister of Health and her Department on the one hand and the PMA on the other hand occurred over the past few months. A major portion of this was expressed in public, in the media. It is crucial to appreciate the real necessity for free speech in order to engage in any weighing up process. The right to free speech can be described as the "indispensable condition of nearly every other form of freedom." Voltaire's ubiquitous " I do not believe a word that you say, but will defend with my life your right to say it" reinforces this notion that free speech is basic to human existence.

In the democratic society that we live in today, it is part of the democratic process to express opinions in order to highlight problem areas or aspects that different parties do not agree upon. These ideas might be expressed in the media. As part of discussions leading up to legislation being promulgated by Parliament, issues can also be discussed (as was the case in this specific matter under investigation) at the public hearings of the Portfolio Committee meetings of the Department of Health. The primary purpose of freedom of speech is to guarantee and enhance the democrat;process. It allows the individual to discuss and debate the merits or otherwise of government activities.

This debate about the prices of medicines and utilisation of generic medicines is not new or unique to South Africa. In the 1997 Datamonitor publication Management Briefings: Generics, it is stated "however generic substitution is subject to strong opposition by the Australian Phammaceutical Manufacturers Association" and "it has even been claimed that manufacturers have propagated myths implying that generic brands are less effective and even un-safe". Both of these statements were also part of the debate in South Africa. Similar debates take place all over the world. Such debates do not only fomm an intrinsic part of the democratic process, they also ensure that inaccuracies are eliminated for the benefit of all.

Because healthcare becomes unaffordable, the health industry in this country, be it in the public or private sector needs to be addressed. The Minister and the Department, being responsible for the formulation of health policies has an obligation to fulfil in this regard. The Department should however endeavour to use correct data in making statements pertaining not only to offending statements 1, 2 and 5, but to all public statements given the special role they have to play in a very crucial area, namely, the health of the South African nation.

PRETORIA
1997-11-21

Signed
PUBLIC PROTECTOR

 

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