SUBMISSION TO THE NATIONAL ASSEMBLY PORTFOLIO COMMITTEE ON HEALTH
ON THE MEDICINES AND RELATED SUBSTANCES AMENDMENT
BILL [B40-2002]
BY
THE PHARMACEUTICAL SOCIETY
OF SOUTH AFRICA
(aa) prescribe such substance- and
(bb) [compound and] dispense such substance only if he or she
is the holder of a license as contemplated in Section
22C(1 )(a);"
words in bold type in square brackets indicates omissions from existing enactments -
Words underlined with a solid line indicates insertions in existing enactments
Motivation
If the word "and" is not included as indicated, then all doctors who may prescribe substances can dispense without a license, as subsections(aa) and (bb) are not linked.
The word "compound" would make it difficult for the South African Pharmacy Council to prescribe a course that includes compounding and dispensing. This would require the full curriculum as currently contained in the undergraduate pharmacy courses for pharmacists.
ii) The same amendments are required in the following subsection
· 22A(4)(iv) Delete the word compound
· 22A(4)(v) Add the word "and" in subsection(aa)
- Delete the words compound and" in
subsection(bb)
22A(5)(d) - Add the word "and" in subsection(i)
- Delete the words "compound and" in
subsection (ii).
· 22A(5)(e) Delete the word "compound"
· 22A(5)(f) Add the word "and" in subsection(i)
Delete the words '"compound and" in
subsection (ii).
The same amendments are required in the following sections
· 22C(J)(a) - Delete the words "compound and"
· 22E(1)(d) - Delete the words "compound or"
3. Section 22A(6)(f) and (I) should be amended by the deletion of any reference to schedule 2, as a pharmacist may initiate sale of these substances and therefore does not need approval for a repeat of a prescription or for a sale in an emergency.
4. Section 22A(15) still refers to the Interim Pharmacy Council. The word Interim should be deleted
5. Section 22A(16)(a) and (b) should be expanded to limit the quantity of scheduled substances that may be in the possession of a person for medicinal purposes.
6 Section 22A(16)(d) is incorrect as a "person who may own a pharmacy" cannot be in possession of scheduled substances. Pharmacies must be registered in terms of the Pharmacy Act and must always be under the control of a pharmacist. It is the pharmacist, and not a possible lay owner, of the pharmacy who may be in possession of scheduled substances.
The words "person licensed to own a pharmacy" in this subsection must therefore be deleted.
7. Section 22G, as introduced by Act 90 of 1997, needs urgent attention. It must be noted that pharmacists also sell medicines on request of the public and over the counter. In addition to this, medicines are sold on prescription.
Open shops are not regulated by this section. This section should therefore also provide for the sale of a medicine by a pharmacist without the requirement that a dispensing fee be charged. If this is not done, the price of cheap OTC medicines may be highly inflated in pharmacies, whilst open shops can sell at any price. This will put pharmacy at a disadvantage.
Recommendation
Section 22G(3)(b) be amended by the inclusion of a subsection (d) that reads as follows
"(d) Paragraph(b) will only be applicable to pharmacists when that sale is done on a prescription by an authorised prescriber."
It is noted that all reference to medical devices has been deleted. Control over the quality, such as sterility, of devices is essential and this proposal to delete control over medical devices is not supported.
Section 22A of the Principle Act as amended by Section 5 of the Amendment Bill introduces the word "specified" scheduled substances. It is fully understood why this is needed as the International Conventions on the control of Narcotics and Psychotropic substances requires information and permits on import and export of these substances. It is however not clear how these specified scheduled substances will be identified in the Act.
Yours faithfully
Ivan Kotze EXECUTIVE DIRECTOR
The Pharmaceutical Society of South Africa (PSSA) is a national. voluntary association of pharmacists representing more than 60 percent of practising pharmacists in South Africa.
As the PSSA is an umbrlla organisation that accommodates the interest groups of pharmacists in the academia, the hospital and institutional sector and the pharmaceutical industry, as well as community pharmacists, this submission should be seen as a joint submission of all these pharmaceutical groupings.
The objective of this submission is not to highlight verbally the comments made in our written submission, but rather to impress on the honourable members of this committee a few points of importance.
The PSSA is therefore appreciative of this opportunity to address this esteemed committee.
Mr Chairman, pharmacists strongly support the objectives of the National Drug Policy and feel frustrated by the long delay in implementation of this policy.
We do understand some of the reasons for this delay but we find it becoming more difficult to explain to our members and the public why the promised changes have not been forthcoming.
A Mr Chairman, the most important point we want to emphasise today is in response to the recent opposition and threats by dispensing medical practitioners in their efforts to block this legislation.
The following should therefore be noted:
1) This matter was extensively debated by this committee in 1996 and a report on this matter was published by this committee in November 1996.
This committee recommended four "non-negotiable criteria". these being
· Medical practitioners will be allowed to dispense where there are no pharmaceutical services available. This decision will be taken by provincial authorities. The Committee added that underprivileged communities must retain their access to affordable medicines.
· The prescribed standards for storage and dispensing facilities, which are determined by the Medicines Control Council, will have to be met before a licence to dispense is granted.
· Prior to receiving a licence to dispense, a practitioner would have to certify that he has completed a course in good dispensing practices. Such a course would not have to include an examination and care should be taken to ensure that it not unduly inconvenient to applicants.
4~4.RTF · The dispensing of medicines, which includes physically handing them out must be done by the medical practitioner him/herself.
2) The emotional statements made that the public will be deprived of access to medicines are incorrect. When Dr Zuma addressed parliament on the 1997 Amendment Bill, she said that:
medical practitioners who dispense in areas that are without pharmaceutical services continue to fulfill an essential service, this Bill does not seek to end such se~2ice. It is however our contention that this type of practice has spread to areas where there is no perceived need, where pharmaceutical services exist in abundance.
3) In the publication Today's Doctor June/July 2002, page 4, The National Convention on Dispensing (NDC) argues that additional controls for dispensing doctors are superfluous as existing legislative powers adequately deals with registration and transgression by dispensing practitioners.
Mi Chairman, the following should be noted
3.1) Existing legislation does not have any penalty clause and a doctor cannot be charged for not registering as a dispensing practitioner i.e. we have legislation with no teeth.
This was confirmed in a letter received by the PSSA from the Health Professions Council dated 27 June 2001. This letter stated that
the Board could not refuse to grant registration for dispensing to medical practitioners who qualified in terms of Section S2 of the Act."
3.2) The PSSA submitted many complaints to the Health Professions Council of South Africa and none of these was satisfactorily addressed or addressed at all. In most of these complaints, the practitioners did not dispense the medicines themselves but used laypersons to do this. (Documents on file)
4) The argument that a "one stop shop" for the public is offered by dispensing practitioners is a valid argument for acute medicines only and this must be attended to by allowing a medical practitioner and a pharmacist to practise for their own account from the same premises. This restriction on group practice, that includes pharmacists, forms part of the Health Professions Act, which states that a medical practitioner can only go into a partnership with those professionals registered in terms of the Health Professions Act.
L Mr Chairman, the PSSA understands the reasoning in extending the provisions for a license before a person can dispense medicines from six months to twelve months and supports this amendment. if however this committee feels that the control over dispensing by medical practitioners should be reconsidered, then the PSSA would strongly object to this and requests an opportunity to make a complete submission dealing again with this matter.
We submit that this committee dealt with this adequately in 1996 and should therefore not revisit this matter.
B The second matter that needs urgent attention deals with technical amendments to the wording of Section 22A as amended by Section 13 of Act 90 of 1997.
Mr Chairman in our submission to the Department of Health in June 2002 on the proposed Bill we motivated why the word "and" should be added to some subsections. If this is not done, a loophole will exist as the Act could then be read as follows
A schedule 2, 3, 4, 5 and 6 substance shall not be sold by any person other than a medical practitioner who may prescribe such substance (Section 22A(5)(d)(i)).
Mr Chairman please note that the requirement for a licence is found in the following subsection 22A(5)(d)(ii). The Act however does not state that he/she must comply with both subsections (i) and (ii) before the scheduled substances may be sold.
The wording as it is currently allows for two scenarios
i) he/she can sell scheduled substances if he/she is authorised to prescribe the substance or
ii) if he/she has a license
Mr Chairman this "loophole" must be addressed and this is done by merely adding the word "and" in subsections 22A(4)(a)(iii)(aa), 22A(4)(v)(aa), 22A(5)(d)(i) and 22A(5)(f)(i).
C Mr Chairman, the last point in this verbal submission that I want to stress is the wording of Section 22A(16)(d).
This Section provides for the possession of scheduled substances by a layperson authorized to own a pharmacy.
Pharmacies must be registered in terms of the Pharmacy Act and must always be under the control of a pharmacist. It is the pharmacist and not a possible lay owner who may be in possession of scheduled substances.
The words "a person licensed to own a pharmacy" must therefore be deleted.
D Mr Chairman, I conclude with an urgent request that our written submission should be fully considered. The written submission highlights other technical amendments that require attention. Please ensure that we now finalise this piece of legislation, in order not to wait for another year to attend to "errors" which will prevent the promulgation of the Medicines Act as amended. Our written submission for example, points out that the words "Interim Pharmacy Council' are still being used.
The PSSA does acknowledge that the proclamation of Act 90 with this amendment will assist the pharmacist in addressing concerns raised over many years, such as those elements that focused on medicine as a commodity of trade, which it is not, but we also submit that the introduction of the principles of the National Drug Policy are in the publics interest.
Thank you