PMA COMMENT ON DRAFT MEDICINES AND RELATED SUBSTANCES
AMENDMENT BILL 23438 as published on 22 May 2002 and finalized in August
2002
General Principles
The PMA supports government objectives of ensuring universal access to sustainable, quality and affordable health care particularly by improving the availability of safe, effective and affordable medicines.
The research based pharmaceutical industry is ideally placed to assist government in achieving these objectives through its unique role in the discovery and development of new vaccines, medicines and treatments for diseases and disorders. To this end, around 300 compounds are presently under investigation in the laboratories of our parent companies.
Industry would like to ensure that the people of South Africa continue to benefit from existing and new therapies particularly in relation to the treatment of TB, Malaria, HIV/AIDS, STDs, diabetes and all endemic illnesses. Industry would like to renew and enhance its multi-billion rand investment in South Africa.
Government and industry's objectives are best achieved by simultaneously ensuring an operational environment of business and legal certainty coupled to secure administrative fairness. Clearly defined legislation and regulations ensure-these ideals and guarantee patient safety particularly by avoiding practices where product integrity becomes questionable.
In a nutshell, legislation and regulations should facilitate:
- Access and affordability of medicines;
- Patient safety through standards ensuring the safety, efficacy and integrity of all medicine;
- An operational environment of business and legal certainty;
- An environment conducive to the sustainability of the research based companies operating in South Africa;
- Uniform legal, regulatory and administrative requirements in order to ensure level playing fields.
Introduction
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 by numerous parties as having the potential to derail government's sound objectives of ensuring access to quality and affordable medicines.
The return to Parliament, for amendment, of Act 90 of 1997 represents an ideal opportunity to alter or remove all deficiencies
Extensive comment on the Act (in its various stages) and on its regulations as published last June, have been submitted by PMA detailing industry's key concerns. Alternative language has also been supplied where requested. Particular attention has been given to ensure that PMA's recommendations - throughout - in no way challenge the stated policy underpinning the various provisions.
We reiterate our belief that certain provisions in the Act and published regulations need to be amended to conform to various South African Statutes and international agreements.
We believe these changes are also necessary to ensure the viability of the pharmaceutical industry - research-based and generic - in South Africa thereby ensuring the sustainability of a supply of quality and affordable medicine to the people of South Africa.
The Bill
General Comment
1. Members of Parliament are urged to assess the correctness of the procedure used to introduce this Bill before Parliament.
While the Bill is introduced as a "Section 75 Bill" as reflected on its front-page and as motivated in paragraph 8 of the accompanying Explanatory Memorandum, this stands in contrast to the so-called Section 76 procedure used to introduce Act 90 of 1997, the Act which this Bill seeks to amend.
In brief, we are advised that they cannot both be right. The wrong parliamentary procedure renders the resulting Act of Parliament incurably unconstitutional. If the State Law Advisors and the Department of Health are now correct in their opinion that the 2002 Bill is to be dealt with as a section 75 Bill then they must have been wrong in respect of Amendment Act 90 of 1997
We are advised that the present Bill should also have been introduced as a Section 76 Bill.
2. In order to offer the most constructive comment possible, PMA has sought to comment on key provisions and omissions in both the Bill and Act 90 - sought to be amended by the Bill - along with related draft regulations as published last June - where appropriate. To do otherwise, would be to omit or misrepresent the effect that this draft legislation might have on the public at large.
KEY ISSUES FOR PMA
The following key issues are of major importance to PMA.
1. Definitions Section 1
Definitions related to "interchangeable multi-source medicines" and "therapeutic equivalence
PMA recommends that additional definitions of "pharmaceutical equivalence", "bioequivalence" and "bioavailability" should be incorporated to ensure that the definition of "therapeutic equivalence" in the Act, which permits generic substitution, is in line with international definitions. [WHO, FDA].
For ease of reference these are included;
Generic medicines are those which contain exactly the same active ingredient [the same salt of the same molecule] in the same strength, and are in the same dosage form.
The term preferred by WHO and other international bodies is
"Interchangable multisource medicines" which are generic medicines, intended for the same use ie. are approved by medicine regulatory authorities for the same therapeutic purpose [and can therefore be substituted].
International definitions of interchangeable multisource medicines are:
WHO definitions:
"Pharmaceutical equivalence"
"Products are pharmaceutical equivalents if they contain the same amount of the same active substance(s) in the same dosage form; if they meet the same or comparable standards; and if they are intended to be administered by the same route. However pharmaceutical equivalence does not necessarily imply therapeutic equivalence as differences in the excipients and/or the manufacturing process can lead to differences in product performance".
"Bioavailability"
The rate and extent of availability of an active drug ingredient from a dosage form as determined by its concentration4ime curve in the systemic circulation or by its excretion in urine."
"B loequivalence"
Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities [rate and extent of availability] after administration in the same molar dose, are similar to such a degree, that their effects can be expected to be essentially the same."
"Therapeutic equivalence"
Two pharmaceutical products are therapeutically equivalent if they are pharmaceutically equivalent and after administration in the same molar dose, their effects, with respect to both efficacy and safety, will be essentially the same, as determined from appropriate studies (bioequivalence, pharmacodynamic, clinical or in-vitro studies."
"Medicine"
The definition needs to be expanded to include complementary medicines. As the definition of medicines is stated to include veterinary medicines, greater legal clarity would be achieved by including a statement that the definition includes "complimentary medicines" since these are often perceived to be different to orthodox medicines.
"Scheduled substance"
The terms 'medicine" and "scheduled substance" have been used interchangeably but not always logically throughout the Act. The definition in the Act should be clarified.
2. Parallel importation Section 15C Background
2.1 While government has elected parallel importation as a mechanism to be used in its efforts to obtain broader access to medicines, careful consideration needs to be given to whether this measure will in fact secure savings for the consumer since:
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International experience frequently shows that any potential savings tend to be absorbed by middle - men rather than being passed onto patients. This could well apply to the SA private sector, where traditionally high distribution costs could negate any potential saving to consumers. (Annexure 1)
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Parallel imports are often associated with the potential for an easing into the market of counterfeit and stolen goods. It is interesting to note that the US recently rejected a proposal to allow for re-importation of goods following government's citing of insurmountable problems associated with sampling and testing of products to identity and remove counterfeit, adulterated or misbranded drugs that could enter the country in large commercial quantities. At a time when stolen stock is rife in SA (sometimes up to 50% of State stock is stolen from facilities while police and the Justice Department, this year, failed to convict a pharmacist on fraud having caught him red-handed with several thousand stolen and counterfeits goods) and the trade in counterfeits is rising rapidly, parallel trade would exacerbate these problems.
To assist government obtain world best prices, industry has instead consistently shown a willingness to offer preferential prices through the State tender system - selling medicines at up to a tenth of the price charged to the private sector - and specific donation schemes. Parallel importation undermines this ability to offer differential pricing, ultimately placing an undue burden on industry sustainability.
Issues
1. If parallel importation is to be implemented, we would ask that the Act and/or regulations be amended to limit the scope of the provisions to ensure that parallel imports are resorted to only in exceptional circumstances and only in order to protect the public interest. This is demanded by the wording of Section 1 SC.
2. This would best be achieved by restricting acts of parallel imports, in the first instance, to the State sector as is envisaged in the National Drug Policy.
3. The circumstances and conditions under which parallel trade may take place need to be specified as is required by Section 1 SC of Act 90 of 1997. Minimum guidelines set out in Article 56 of the Patents Act of SA reflect many of the acceptable international norms in this regard and could serve as helpful guidelines.
4. The wording of Section 1 SC itself places this section within the ambit of TRIPS Article 31 provisions which also demand certain due process with regard to provisions and procedures
5. The Minister of Health's public undertaking to apply the concept of parallel importation only to authentic products is appreciated as is her undertaking that compulsory licensing will only be authorised through the Patents Act. This should be enshrined in the regulations;
Draft Regulations
6. Regrettably, the regulations to Section 1 SC, published last June, suggest that parallel trade will be open to all traders - including private sector players with inadequate controls. This disruptive activity could threaten the viability of the private sector.
7. Specifically, in their present form, industry believes that the proposed regulations (as published in June 2001) are inadequate to control the quality, safety, and efficacy of imported medicines [purchased on international tenders and by means of parallel imports]. These omissions could prove deleterious to patient safety.
8. While parallel importation is to be licensed, the criteria for consideration of an application are absent;
9. Regrettably, draft regulation 7(11) seeks to legitimize the unauthorized use of local packaging, trademarks and copyrights for imported products marketed under a different name overseas. This would enhance the entry into the market of counterfeits, substandard or stolen medicine with enormous cost implications for patients. Regulation 7 (11) is also not consistent with local and international trademark law. Moreover, the section has major implications for product liability, particularly in the case of product recalls.
10. Absent in the draft regulations is a provision that says the parallel license will be revoked if the circumstances under which it was granted cease to exist or where no price differential exists;
11. Should Parallel importation occur, no re-exportation of parallel imported products should be permitted.
12. Current criteria for the registration of medicines and approval of post-registration amendments [variations] are fairly stringent. It is untenable and unfair to have different criteria regulating medicines imported by a third party. The application of identical registration standards and the cost of an added bureaucracy needed for the application process of parallel imports must be costed into the overall evaluation of savings to be effected by the imported goods.
3 Code of Ethics Section 18C
The PMA acknowledges improvements in the changes to the wording of Section 1 8C which now seeks to regulate the marketing of medicines by all stakeholders - not only pharmaceutical companies. This is a key amendment given that the marketing of medicines endures throughout the entire distribution chain – long after they exit the manufacturer's gates.
The wording of Section 1 8c now reads: 'The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines"
We recommend the inclusion of the words...: "'providing for a Marketing Code of Practice and die enforcement thereof by a body consisting of/or including representatives of the pharmaceutical industry."
Such an amendment is in line with extensive government/industry collaboration during the past year that culminated with government expressing an intention that a code of ethical marketing practices be self-regulatory with legislative back-up provided only for "maverick" companies seeking to evade good marketing practices.
Without amendment, while the title refers to a "Code of Ethics" this language is absent in the substantive text. (The title should in any event refer to a Code of Practice since ethics are less tangible.)
The present language suggests that the Minister will now regulate the marketing of medicines. This implies that contraventions will be punishable by the criminal sanctions provided for in the Act and through customary court process, which might be lengthy, costly and impractical and inappropriate in delivering redress.
In seeking to create a self-regulatory environment backed up by a statutory and regulatory code of ethics, parallels should rather be sought from appropriate laws such as the Pharmacy Act and the Attorneys Act. Appropriate penalties might, for example, include a letter of withdrawal of false, misleading or unapproved claims to be sent to health care professionals or a withdrawal or apology to be published in appropriate journals or other publications rather than a 10-year imprisonment for the CEO of the offending company.
4. Pricing Committee Section 22G
The limitation of the term of the pricing committee to a maximum of five years is welcome, though a lesser time - say three years - might be more appropriate to ensure greater accountability and good governance.
The provision (by the insertion of Section 22G (2) (c) for a fee to be paid to wholesalers is an improvement on the original Act where no provision was made for the re-imbursement of the wholesaler.)
The Bill however fails to specify who will pay this fee, since no change has been made to the definition of "single exit price" being the only price at which manufacturers shall sell medicines and which is the same price at which pharmacists and others (registered to dispense) shall sell medicines to patients. While Section 22G (3) (c) allows pharmacists and other registered dispensers to add a dispensing fee to the single exit price, this section does not apply to the wholesaler.
Recommendation: Section 22G (3) (c) should be rewritten as follows:
"Paragraph ~) shall not be construed as preventing a pharmacist or person licensed in terms of this Act to charge a dispensing fee as contemplated in subsection (2) (b); nor shall it be construed as preventing a wholesaler or distributor charging the retailer an appropriate fee as envisaged in (subsection) (2) (c)."
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Without such an amendment, it is not clear that the retailer will be able to recover from the patient, the wholesaler's fee over and above the single exit price and the dispensing fee.
Clarity is still required for the following issues In particular:
a. there is a lack of clarity regarding the scope and function of the Pricing Committee. The Act should contain transparent, objective and verifiable criteria for decision-making, time frames and appeal and review procedures for the Pricing Committee.
b. Section 22 G (3) (a) needs amendment to make clear government's stated intention that it is the manner of publication of the price that needs to be prescribed rather than the price itself Such an amendment is essential to dispel the misunderstanding that this section could envisage price controls
- a policy that is clearly outlawed by GEAR and the Department of Trade and Industry.
c. At odds, in the section, is clause 22G (2) (a) that states that the Minister "on the recommendation of the Pricing Committee, may make regulations on the introduction of a transparent pricing system..." This provision implies that the Pricing Committee and the Minister, after duly applying their minds, may make a recommendation for a transparent pricing structure.
d. The committee and the Minister, however, are given little opportunity to apply their minds to the fundamental type of structure they believe to be desirable since the Act in Section 22G (3) (a) later specifies that such a system will have a "single exit price that shall be the only price at which manufacturers can sell medicines to any person other than the State."
e. We submit that clarity is needed as to who or what will determine a pricing framework. Either the Act must specify clearly the details of a pricing structure or the pricing committee must be given this function within specified criteria that stipulate their powers and functions. Alternatively, the section, in its entirety should be deleted.
5. Section 22 F - Generic Substitution Background
Industry recognises that generic medicines, introduced following an adequate period of market exclusivity for the innovator, have a valid place on the market. Within an appropriate framework of regulatory policies, safeguards and practices, they can offer the prescriber and consumer a legitimate choice between products.
Given that the generic manufacturer does not carry the considerable risks associated with innovation - estimated at up to US$1 bn to bring a new chemical entity to market after around 12-14 years - quality generics should be able to compete favourably in the market place on price alone without any legislative assistance.
Active generic usage in South Africa has been prevalent in the private sector for at least the past fifteen years and around 30 years in the State sector. Indeed, generics account for 49% of all medicine sold nationally in South Africa (in volume terms) and around 26% nationally in value terms (see annexures 3,4,5).
The wording in the Bill and the Act
The mandatory nature of the provision as enshrined by the word "shall" instead of may appearing in the first line of the provision remains problematic for a number of reasons.
The most important issue being the question of who bears legal liability in the case of an adverse reaction or error in substituting a non-substitutable product.
This mandate to the pharmacist and other dispensers:
a. Further negates the doctor/patient relationship by potentially allowing a substitution to take place by default since the doctor is not forced to apply his mind to the matter of substitution. This might be overcome through a tick-in box on the script that would alert the doctor and patient - at the consultation level - to the opportunities and limitations of substitution;
b. conflicts with the pharmacist's Constitutional right to freedom of speech -ie the freedom to remain silent on a drug which he might believe has no or questionable benefits apart from cost savings.
Recommendations:
1. The replacement, at least, of the word "shall" with "may" would serve the objective of legalizing substitution by a pharmacist and fostering generic competition effectively without the above dangers.
2. The standardizing of related definitions of pharmaceutical equivalence, bioavailability, bioequivalence and therapeutic equivalence to bring these into line with internationally accepted definitions as recommended earlier in the "definitions" section.
6. Appeal Committee Section 24
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Removal of the right of appeal against a decision of any authority to a court of law tends to be seen as the removal of a basic Constitutional right along with protections available under the Administrative Justice Act. To this extent, the right of appeal to the High Court for all decisions should be re-instated.
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While the re-instatement of the Appeal Committee to hear appeals against the decision of the Medicine Control council is welcome (this was removed in the first published Bill), PMA is concerned about two important down-gradings:
6 1. The chairman is now proposed merely to be appointed "on account of his or her knowledge of the law", and is no longer required to have had at least 10 years experience as Amendment Act 90 of 1997 introduced. (This is already a downgrading from the present requirement which calls for a retired judge or advocate with 5 years practice experience.)
2. Secondly, the appeal from the Appeal Committee to the High Court introduced by Act 90 of 1997 stands to be removed by the adoption of the 2002 Bill. This is a sad turnaround from Amendment Act 90 of 1997.
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While the heading of Section 24 refers to an "Appeal against . . .the Director-General", we believe that the proposed provisions of section 24(6) do not create a procedure that may properly be called an appeal:
1. It provides that one aggrieved by a decision of the Director General may "make written representations with regard to such decision to the Minister" who may then confirm, set aside or vary the decision of the Director-General. The fact that an appeal against a decision of the director-General to the Appeal Committee no longer exists is regrettable.
2. No guidance is given on the basis upon which the Minister is to make her decision in this regard. This is not, thus, an appeal in the normal sense of the word.
3 It is also to be noted that this authority of the Minister is not subject to the prohibitions with regard to delegations provided for in section 34A(1) of the Act. In terms of this provision the Minister may delegate any authority (save certain specified ones) to the Director-General or to any other officer of the Department.
The Director-General may likewise, in terms of section 34A(2), delegate any power, duty or function which he or she has, other than one delegated to him or her by the Minister in terms of section 34A(1).
Collectively this creates a situation wherein it is conceivable that the Minister may delegate to a person who reports to the Director-General, the authority to consider an4 rule on the "representation/appeal "in respect of a decision of the Director-General. This cannot be tenable?
7. Powers of Inspectors - Search and Seizure Section 28
The PMA - in collaboration with the Department of Health and for the past seven years, has actively sought to do everything possible to halt the theft and pharmaceuticals and other black-market medicines dealings.
The original Section 28 of Act 90 of 1997 was declared unconstitutional by the Constitutional Court in the case of the MCC against Mistry as the powers of inspectors were deemed to be too wide. It is, therefore, absolutely imperative that a successor to Section 28 comply fully to the dictates of the Constitution.
In this regard the following should be noted:
1. The Constitutional Court declared the old section 28(1) to be unconstitutional for being in conflict with the fundamental right of privacy Judge Sachs summarised the issue as follows:
"The most striking feature of section 28(1) is the lack of qualification of the powers of entry and inspection given to the inspectors. In general terms, the only requirement imposed is that the powers must be exercised at reasonable times. The single criterion for entering "any premises, place, vehicle, vessel or aircraft" is that any medicine or scheduled substance is there or is reasonably suspected of being there. Defined as it is to include any substance used for the treatment of disease or its symptoms, the term "medicine" covers the kinds of analgesics, ointments or influenza relief potions to be found in the majority of South African homes. Once on the premises, the inspector may look not only at any medicine or scheduled substance, but also at "any book, record or document". The result is that inspectors are given the power to enter any home where aspirins, ointments or analgesics happen to be, and once there, may inspect not only medicine cabinets or bedside drawers, but also files which might contain a person's last will and testament, private letters and business papers."
The Bill is specifically intended to overcome the unconstitutionality of section 28.
2. The draft bill published for public comment on 22 May 2002 proposed a regime wherein almost all inspections, searches and seizures by the Inspectorate were to have been made under authority of a warrant granted by a Judge or Magistrate on application under oath, albeit not necessarily with notice to the person to be inspected. This form of judicial control over inspections, searches and seizures has now been abandoned and will be difficult to justify in the event of a Constitutional Court challenge.
3. The new proposal is that any Inspector may at any "reasonable" time enter any premises without a warrant, on a reasonable suspicion of a contravention of the Act. They can do so simply on the basis that a "person being visited" is a holder of a certificate of registration of a product (clause 28(1)(a)(i)(cc).
4. A warrant to be issued by a justice or magistrate is now only required to search a private dwelling, and then such warrant may be dispensed with if the Inspector "believes on reasonable grounds that- (a) the warrant will be issued if he or she applies, and (b) a delay in obtaining such warrant would defeat the object of the entry."
5. Once lawfully on a person's premises, the Inspector may inspect any medicine, substance, book, record "that he believes on reasonable grounds contains any information relevant to the administration of this Act".
The suspicion thus need not be that a person contravenes the Act, it can also be a suspicion that the person complies with the Act - it is as "relevant to the administration of this Act" as is contravention. This gives the Inspectors almost carte blanche to delve into every hard disk, server, drawer and filing cabinet. We submit that a power as broad as this will never withstand the scrutiny of the Constitutional Court.
6. Having thus entered in the above manner, the inspector may seize and take samples of any "medicine or scheduled substance as he may consider necessary for the purpose of testing, examination or analysis". Curiously however, the inspector is not authorized to seize any such record, book or document as her/she may have inspected.
Regrettably, this provision could allow the law abider to be hassled without the benefit of ensuring that the counterfeiter or other contravener is placed behind bars.
7. There are also some technicalities which require tidying up in this section: e.g. Section 28(2) of the Act now refers to section 28(1)(d) which is no longer to exist.
In the final analysis, we do not believe that the very noble attempts to render Section 28 constitutional and compliant with the fundamental right to privacy have been successful. Our fear is that this section will be overturned if again challenged by a person charged with contravention of the Act. The powers need to be limited more closely in the manner in which they were drafted in the first published Bill.
OTHER CHANGES RECOMMENDED BY PMA
1. Section 3- Constitution of the Council
The omission of specified skills in constituting the Medicines Control Council should be rectified by the inclusion of a provision stating that "the majority of members are to be from scientific disciplines which should include a mixture of persons with pharmaceutical, clinical and regulatory expertise".
Such a provision is intended to protect the best interests of the public by ensuring that the country's best scientific and medical expertise contribute towards the determination of the safety and quality of the supply of medicine.
2. Section 6- Disqualification for appointment to Council
The 6(1) (d) "Ban on any Council member being employed in the pharmaceutical industry" is ill-considered given the exclusion of anyone with practical business and manufacturing expertise.
We re-iterate that Council deliberations could only benefit through insight into industry operations and constraints.
We submit further that any potential conflict of interest could be pre-empted through transparency and full prior disclosure.
The Act requires that the Council's internal rules of conduct must be published in the Gazette. This has not been done as yet.
OTHER CHANGES INTRODUCED IN THE BILL THAT IMPACT ON INDUSTRY
1. Reverting to the use of "The Minister of Health or Director-General " as opposed to Department Sections 22C, 22D, 22E, 22H, 24,35
The removal of all references to the "Department" in place of the "Director-General" - appearing in the first-published Bill - are welcome by industry.
Following publication of the first Bill, PMA was concerned that in practice, the Bill might allow the situation to arise where even junior officials of the Department could make far-reaching decisions in the name of the Department, although they may not have had the experience or knowledge to appreciate the consequences of such decisions. This could have had tremendously adverse consequences for the public and for industry. There was also no legal authority to be found for such a delegation.
2. Deputy Registrar position - Section 12
We welcome the creation of the new positions of "Deputy Registrar' if this is intended to reduce the work load of the Registrar.
However the Bill or regulations should outline the exact powers that the Deputy Registrar[s] will enjoy. For instance, the Deputy Registrar must be able to act for the Registrar in her absence eg. she/he must have the authority to sign Certificates of Registration. This could assist in removing some of the bottlenecks /backlog which are a cause of immense frustration to industry.
In its present form, the Bill states that the Deputy Registrar(s) may only "assist" and only "exercise any power" of the Registrar "subject to the approval of the Registrar". This scenario will not allow for efficient delegation of duties. The authority to delegate specific tasks to deputies would be preferable
The proposed provision does not indicate clearly whether the Registrar will be in the employ of the MCC which is now to be a legal person, or still be employed by the Department of Health.
It should be made clear whether the Registrar is within or outside the Department. [and whether he/she will be subject to the rules of employees of the Public Service Administration or not.]
Given that the Registrar shall be required to take orders from the Minister, the
Director-General and the Council, The PMA is concerned that the Bill appears to have abandoned the ideal of an independent Medicines Control Council.
3 Schedules of Medicines Section 22A
Reference is made to Schedule 8 in this Section [Subsection (8)]. The only further reference to S8 under Act 90 of 1997, appears in Subsections (11) and (12). There is no reference to a Schedule 8 in the recent publication of Schedules under Act 101.
Clarification is required on proposed changes to the Schedules.
The word 'or" in Subsection (8) suggests that both schedules 7 and 8 products are to be involved. Without knowing what the criteria will be for classification of a medicine in a specific Schedule, it is not possible to comment on the appropriateness of the measure, but the principle of it seems to be in order.
In subsection (11) the conditions for issuing an import or export permit will be determined by the Director-General in place of publication as Regulations. This creates unnecessary uncertainty and allows the Director General unfettered discretion. The law and regulations should lay down some directions as to how the discretion is to be exercised.
In subsection (16) possession of prescription only medicines [in S3-S6] is permitted. The intention with this amendment is unclear, possibly because of the rolling into one of the requirements for lawful possession of medicines by patients and by prescribers.
It seems that the intention should be to provide that any person holding a valid prescription for any medicine which may be bought on prescription (even Schedules 7 and 8) may posses it, and that an authorized prescriber, (to which should be added any licensed manufacturer, importer, wholesaler and retail pharmacist) may posses any medicine with the proviso that Schedule 7 and 8 medicines require authorization by the D-G in terms of sub-section (8) above.
Licensing Section 22C, 22D, 22E
The period for this section to come into operation has been extended to 12 months. For practical and logistical reasons, this is more realistic and is welcome.
CONCLUSION
The proposed amendments to the Act which have clarified the intention of the legislator in certain sections are welcome.
PMA trusts that its key recommendations will be considered in the spirit of co-operation in which they are submitted.
Legislation that lacks clarity, certainty and legality can only result in confusion and resentment - neither of which are conducive to an environment necessary to ensure a sustainable supply of quality and affordable medicines.
The PMA and its members wish to remain a core component to such an environment.