SALDA Presentation to the Honourable Portfolio Committee on Health Medicines and Related Substances Amendment Bill - 5 August 2008 -

What are we covering SALDA IVD Definition Exploring the Lab Section 18 (A) to (C) of the Act International Tendering Similarities with other Countries Proposals

What is SALDA The South African Laboratory Diagnostics Association Represents >90 % of the In Vitro Diagnostic (IVD) or laboratory diagnostic industry Associate member of SAMED, as IVD is defined as a medical device Support regulation of our industry to ensure quality healthcare to the South African patient SALDA wants a framework to be established by the Act which will ensure effective regulation, in the interest of patient safety and quality

“foodstuff” & “cosmetics” Part 1: “Products” “medicine” “foodstuff” & “cosmetics” “Product” “device” As defined in the new amendment, “product” now covers a wide arrange of products – everything will be governed the same. (Medical Devices and IVD’s are the MOST different products) Medicine = allopathic, veterinary, tradition & complementary Foodstuffs etc = those which makes medicinal claims (“lowers cholesterol”) Devices = IVD’s, scanners, blood pressure monitors, consumables, assistive devices (wheelchairs) THIS MEANS THAT: although they are very different, they will be governed by the exact same rules! * Red circle: LET’S EXPLORE OUR WORLD, THE IVD WORLD…

How does IVD add value to healthcare provision? We would like to start this presentation just talking about what an In vitro Diagnostics is and how legislation in other countries have been structured for IVD and other medical devices.We need to highlight that according to the ACT IVD’s are classified as a medical device. Use TB example that we have used in the written submission to illustrate the value that IVD adds to the quality of health the SA patients receive. IVD’s have changed from being just an indicator of the absence or presence of disease to being very specific to monitoring of patients response to treatment and aiding in more accurate management of the patient as a whole.

SALDA proposal on the insertion of a definition of IVD in the Act: In vitro diagnostic medical device means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles (refer GHTF). (for more detail, refer our submission) This definition aligns with that used world-wide, and would assist in ensuring an efficient, cost-effective way of regulation, by aligning with other authorities and global agreements.

The IVD Value Chain Manufacturer Laboratory Doctor Patient R&D Manufacturing Marketing Sales Service Training Repairs Process blood samples -> Report on Result E.g. HIV,Chol Interpret Blood result -> Clinical Decision Treatment Treatment Life style Monitoring Just focussing on the laboratory now this is what happens in the value chain. IVd’s are very different to medicines which has a very simple value chain – the wholesaler ->pharmacists->doctor ->patient. For IVD there is a complex and continuous relationship between the la and manufacturer which involves continuous training on the equipment, servicing the lab equipment , repairing the equipment using spare parts that must always be available. Various specialist skills are needed to ensure that a blood result is generated like technologists , applications specialists, technicians, engineers etc from the design of the equipment to the use, maintenance and repair of it. The blood sample is then processes using various lab equipment and reagents and then is interpreted by a specialist pathologists. This interpreted result is then given to the doctor who togethr with other results and his clinical examination he will then treat the patient. For patient self- monitoring tests that are sold in the pharmacy the patient is able to monitor their own sugar levels using an IVD and so manage their disease – this has changed the way in which many diabetics manage their illness and has prevented complications like diabetic coma’s that add to the hospitalisation and possible death and costly medical bills. RED CIRCLES: This is different from medicines, as a medicine is prescribed and dispensed and there is no further engagement by the manufacturer (i.e. no repairs), in medicines, the user = the patient, in IVD the user = medical laboratory technologist Instrument (Capex) / Analyser + Reagent+ Service+ Interpretation= Blood Result

IVD Value Chain different from … Clinical Engineer Maintenance, etc (surveillance) IVD Value Chain different from … Medical Technologist (“user”) Pathologist Patient’s Doctor Patient Manufacturer Laboratory … Medicine Value Chain Patient’s Doctor Surveillance (adverse reactions, etc) Differences between medicines supply chain and devices supply chain warrants differences in legislative frameworks to ensure effective regulation, i.e.: RED CIRCLE: The PRODUCT features at different stages of the cycle. In the medicines chain, the patient takes the product HOME, and becomes the USER. BLUE CIRCLE: Different types of PROFESSIONALS are involved, and at different stages – unlike pharmacist, pathologist and medical technologists are NOT in contact with the patient, but have DIFFERENT RESPONSIBILITIES. GREEN CIRCLE: The persons, places and responsibilities relating to POST-MARKET SURVEILLANCE is totally different. USER: The training of the USER is important in IVD’s, no training needed for USER (patient) in medicine. Manufacturer Wholesaler Pharmacist Patient (“user”) Medicine

Everyone is defined in the Act with medicines, BUT WITH IVDS THEY ARE NOT IDENTIFIED!!!!!!

“foodstuff” & “cosmetics” Part 2: “Legislative Proposals” “medicine” “foodstuff” & “cosmetics” “Product” “device” As defined in the new amendment, “product” now covers a wide arrange of products – everything will be governed the same. Medicine = allopathic, veterinary, tradition & complementary Foodstuffs etc = those which makes medicinal claims (“lowers cholesterol”) Devices = IVD’s, scanners, blood pressure monitors, consumables, assistive devices (wheelchairs) THIS MEANS THAT: although they are very different, they will be goverend by the exact same rules! * Red circle: LET’S EXPLORE OUR WORLD, THE IVD WORLD…

The importance of risk classification e.g. Blood Grouping is a high risk to patient unless done by qualified personnel. The Act does provide for Medicines to be scheduled, but no process for the paralell in devices, i.e. RISK CLASSIFICATION.

Implications of international tendering for this device? Point to a part in this: “imagine if this was a parallel import and the implications for patients – NHLS not being able to process samples – and machine would be out of service – will affect healthcare provisions”!!!

“Fourth hurdle” = barrier to market entry on non-scientific grounds Why getting market access is important the development of appropriate healthcare solutions, the development of science and technology, and creating appropriate technical skills on the use of the device, and similar devices, for South Africa. What would have happened if the 1st HIV tests were not allowed to be sold in SA These powers are to be exercised as part of PROCUREMENT and REIMBURSEMENT, separately . Medical schemes has the power, in terms of the Medical Schemes Act and regulations to take cost-effectiveness into account. Similarly, the DOH, through the tender system, has the power to apply these principles and could take into account provincial variations, such as for example XDR TB rates in one province, which may need a specific devices, whilst others may not need it. This may not be foreseen at registration…. Use TB example in submission to further explain.

Bonusing, sampling, rebates: Certain practices enhance access & quality and should be allowed The importance of workflow and of companies to be able to supply devices to a lab for testing purposes before they buy it…

Bonusing, sampling, rebates: Certain practices enhance access & quality and should be allowed Cross-merchandising agreements (e.g photo copier & cell phone contracts) Instrument & product evaluation Warranties Pro bono provision Transparency in economies of scale SOLUTION: s18A&B to refer to regulations to define acceptable practices, and outlaw unacceptable practices S18C: SALDA has a Code of Ethics which could be issued in terms of this section

Are there perversities which drive up costs in the IVD sector? Analysis has shown that IVD (equipment & consumable costs) are approximately 20% of the NHRPL pricing of IVD-related services SALDA has a code of ethics (which also aligns with HPCSA Policies), which governs: Sponsored product training and education Agreements with consultants Gifts Reimbursement for economic information Donations None of which may occur as a quid pro quo for the utilisation of any specific product or support to any particular supplier.

Medicine ≠ devices Medicines bill has several requirements that are not appropriate to IVD’s Cannot sample this device before registration Cannot accommodate labeling on immediate outer container of this device No package inserts, but user manuals, etc This device has no therapeutic efficacy No pharmacist, but medical technologists, pathologists, engineers, etc The Act should empower that

What are other countries doing? THESE SHOW THAT ALL THESE OTHER COUNTRIES HAVE SPECIFIC SECTIONS OR CHAPTERS FOR DEVICES AND IVDS’, AND SOME COUNTRIES EVEN HAVE SEPARATE ACTS. Talk about GHTF as a trend and to ensure separate regs for IVDs and separate guidelines – would assist in making the regulation of IVDs cheaper and more efficient in SA, and make our products more exportable. Most countries have separate sections, chapters or Acts for devices and IVDs

What must be empowered in an Act? CIRCLES: Our Act does NOT provide for all of these empowering provisions, or provide for it in wrong manner, e.g. they provide for disposal of medicines, whilst machines are “de-commissioned”.

SALDA proposal Proposal 1: Alignment with global trends in emerging and mature regulatory authorities Delete the word “medical device” from product definition Insert proposed definition of medical device and IVD into definition section New chapter/section created for Medical devices and IVD in Act Capture the nuances of the industry Prevent loopholes Ensure effective implementation structure Proposal 2: Alternative: specific wording changes to make Act implementable and effective – refer Annexure B of submission

Thank you for your time Chairman: Mr H. Rootman. hennie@pathteq-qpl.co.za (011) 314-0048

Amendment to the Medicines ACT By replacing the word “medicines” with “product”: The Act does not capture all of the specialist skills required to register and monitor an IVD . Regulation may be challenged as being ultra vires as the Act des not capture the nuances of the IVD and Medical device industry All of the players within IVD and medical device industry not defined in the Act as they would all need licences not just pharmacisists International tendering may not be appropriate for IVd and other large medical devices due to the vital training and after sales service that may prevent continuity of essential service suplies eg. HIV testing “Therapeutic efficacy” in the Act not appropriate for IVD’s and medical devices Labelling requirements for IVD and medical devices different to labelling for medicines

Amendment to the Medicines ACT (2) Sampling and bonussing for medicines not the same as for medical devices and IVD Normal and acceptable business practice within this industry may be outlawed Risk of access denied to new technology to SA patients eg. Cell phone contracts Risk of SANAS accreditation process being threatened for product evaluation

Amendment to the Medicines ACT (3) This criteria is not common practice globally for IVD’s and we are unsure how this will be implemented Risks associated with this additional 4th hurdle include: Delayed time of entry to new innovation which may in a resource constrained environment like ours aid in patient access to diagnostic tests Potentially discourage investment Decrease the introduction of new innovations

How have other countries legislated health products In all countries medicines have been legislated first followed years later by the inclusion of other health products including medical devices and IVD In Canada – a separate section was added for medical device and IVD USA – Food and Drug Act has a separate section for IVD and medical devices Australia – separate chapter for IVD and medical devices with separate definitions India – Separate legislation and structure fr medical devices and IVD No country has replaced the word medicine with product Elsabe please have a look at wording – a table might also be effective but may appear too simplistic . Need to go through each country and if we can give greg a brief history on when new legislation was introduced for IVD and medical devices and IVd would be great!