‘Sustainable health and enhanced wellness ...naturally’

1. Complementary Healthcare Council of Australia ‘Sustainable health and enhanced wellness ...naturally’ INTERNATIONAL REGULATORY TRENDS

2. COMPLEMENTARY HEALTHCARE COUNCIL The Complementary Healthcare Council (CHC) is recognised nationally and internationally as the peak body for the Australian natural and complementary healthcare products industry. Membership includes suppliers, manufacturers, wholesalers, retailers, individual natural healthcare practitioners and consumers. CHC represents more than 75% of companies that sponsor therapeutic goods, which in turn represents more than 85% of the total retail market.

3. COMPLEMENTARY HEALTHCARE COUNCIL Vision “Sustainable Health, enhanced wellness…..naturally” Mission • To provide leadership by promoting natural healthcare to all Australians. • To enhance and encourage a robust sustainable natural & complementary healthcare products industry. • To be recognised by Government, media and all stakeholders as the peak body for natural and complementary healthcare products.

4. COMPLEMENTARY HEALTHCARE COUNCIL CHC is committed to playing a major role in facilitating a paradigm shift in the development of health policy from a disease care model to one based on preventative healthcare. Establishing a regulatory model for natural and complementary healthcare products that facilitates sustainable health and enhanced wellness through the use of high quality low risk products. Developing standards, regulations and guidelines that are consistent, appropriate and based on the COAG principles of minimum regulatory intervention.

5. GLOBAL ALLIANCE International Alliance of Dietary Supplements Association (IADSA) IADSA brings together 40 associations from 6 continents. IADSA aims to build a sound legislative and political environment for the development of the dietary supplement market worldwide. IADSA communicates information and ideas around the globe to regulators, consumer organisations, scientific bodies and national associations.

6. GLOBAL ALLIANCE International Alliance of Dietary Supplements Association (IADSA) In today's global village it is critical that we have and organisation such as IASDA representing all stakeholders in the dietary supplement international arena and providing a channel for world wide communication.

7. AUSTRALIAN REGULATORY ENVIRONMENT THERAPEUTIC GOODS ADMINISTRATION (TGA) TGA regulates all therapeutic goods sold in Australia. Therapeutic Goods are regulated in two categories: Listed – evaluated for safety & quality Registered – evaluated for safety, quality and efficacy TGA maintains a register of all therapeutic goods (ARTG) All therapeutic goods must be manufactured under the PIC/S GMP code.

8. PAN RECALL On the 28 April 2003 TGA suspended Pans manufacturing license and ordered a voluntary recall of all products manufactured for a 1 year period. Australian sponsors recalled 1,624 therapeutic goods and 1,650 Pan exported products were cancelled from the Australian register. The regulatory cost of the recall was $17.2 million The Pan recall was unprecedented in its size, scale and complexity - It was the largest recall of medicines in the world!

9. PAN RECALL Pan was liquidated in November 2003. The facility was purchased by Sphere P/L and the facility will continue to manufacture complementary healthcare products. Sphere P/L is under the directorship of Mr Bob Power. Bob Power has been manufacturing complementary healthcare products for 30 years. He is one of Australia’s most respected contract manufacturers. He is recognised as an expert in the field of herbal extractions.

10. AUSTRALIAN REGULATORY ENVIRONMENT Australian Regulatory Changes Post Pan The Australian Government acting quickly to introduce new regulatory provisions. • Increases to maximum penalties for a range of existing offences. • New offences for falsification of statutory documents. • Expansion of the compulsory public notification and recall procedures.

11. AUSTRALIAN REGULATORY ENVIRONMENT Australian Regulatory Changes Post Pan • Insertion of a “fit for purpose” test into the provisions for granting a licence. • New statutory conditions of licence to ensure compliance with manufacturing principles. • requirement for sponsors of therapeutic goods to maintain records of all manufactures and to notify the TGA of any changes. • Provisions for better identification of therapeutic goods in the event of a recall and improved adverse reactions reporting.

12. AUSTRALIAN REGULATORY ENVIRONMENT Proposed Australian Regulatory Changes The Governments Expert Committee on complementary medicines has recommended the following new provisions: • Quality standards for all ingredients for use in therapeutic goods are legally enforceable. • Sponsors be required to submit to the TGA a summary of the evidence that supports the efficacy of the listed good.

13. AUSTRALIAN REGULATORY ENVIRONMENT Proposed Australian Regulatory Changes • The TGA to substantially increase random and targeted assessment of the evidence to support indications and claims. • Homoeopathic and related remedies making therapeutic claims to be regulated to ensure they meet appropriate standards of safety, quality and efficacy. • Review of of the regulations of raw herbs and other starting materials for the manufacture, dispensing or extemporaneous compounding of medicines.

14. AUSTRALIAN REGULATORY ENVIRONMENT Trans Tasman Harmonisation In November 2003 the Australian and New Zealand governments signed the Trans Tasman Harmonisation treaty. The treaty will establish a joint agency to regulate therapeutic goods including supplements. Legislation to establish the new agency is expected to be tabled in the early part of 2004. The plan is for the new agency to start operating in July 2005

15. AUSTRALIAN REGULATORY ENVIRONMENT TGA ASIAN PACIFIC ACTIVITIES TGA International training has seen participants from the following Asian countries: Indonesia, Malaysia, China, Singapore, Japan, Fiji, Thailand, Sri Lanka, Philippines and Vietnam. The TGA International training sessions have increased in demand. Particularly from the various regulatory agencies in the Asian Pacific region.

16. AUSTRALIAN REGULATORY ENVIRONMENT Australian Regulatory Trends • Increased PIC/S GMP auditing program • Increases in the regulatory requirements for the manufacturing of therapeutic goods. • Increases in the assessment of the levels of evidence to support indications and claims. • Increases in the requirements for establishing the safety and quality of raw materials used in therapeutic goods.

17. REGULATORY TRENDS- CANADA Office of Natural Health Products - Canada In March 2001, the Proposed Regulatory Frame work for Natural Health Products was drafted. The office of Natural Health Products was established and Dr Phil Waddington was named as the Director. The legislative provisions for natural products sold in Canada include licensing of products and sites, GMP, labelling and packaging and reporting of adverse reactions. Recently an Expert Advisory Committee was formed to provide scientific advice on issues relating to safety,quality, and efficacy.

18. REGULATORY TRENDS- CANADA Office of Natural Health Products - Canada The new Canadian Natural Products Regulations will come into force on 1 January 2004. The Natural Health Products Directorate will publish 90 product monographs by January 1 2004 A further 300 monographs are in the development stage. The monographs will provide a simple route to market for most products.

19. REGULATORY TRENDS - CANADA Office of Natural Health Products - Canada The Canadian regulatory model for natural health products is unique in that : • It provides a separate directorate for natural health products. • Its leadership comes with a background in the science of natural therapies. • Regulations are being applied that are appropriate to the low risk nature of natural health products.

20. CODEX - STANDARDS Codex is currently working on four important documents for the vitamin and mineral supplement industry: • The CCNFSDU committee is working on the Proposed Draft Guidelines for Vitamins and Mineral Food Supplements. • The codex Committee on Food Labelling is developing guidelines for health claims on foods, including food supplements. • Codex is developing a common list of additives so that dietary supplements made in one country may be sold in the other 164 Codex member countries. • The Codex Committee on General principles is establishing basic principles for risk assessment.

21. EUROPEAN UNION - TRENDS Important European Union Documents • The Food Supplement Directive (FDS) was passed into European law in July 2002. • The EU Traditional Herbal Medicine Products Directive is expected to be completed by mid 2004.

22. EUROPEAN UNION - TRENDS Timetable for other European Supplement Legislation: Fortified foods - regulations completed end 2006 Food Safety Dossiers - directive completed August 2005 Health claims - regulations completed late 2005 Allergens - directive completed Dec 2005

23. EUROPEAN UNION - TRENDS The EU are also currently consulting on two amendments to the EU GMP Guide. • Product Quality Review (proposed addition to Chapter 1 of EU GMP Guide) • On going Stability (Proposed addition to Chapter 6 of EU GMP Guide) Once these documents are completed they will automatically be picked up in the PIC/S GMP Code

24. REGULATORY TRENDS -KOREA In 1993 the Oriental Medicines Bureau was established. Korea has developed a separate category for natural healthcare products. One major project of the bureau is the cooperation with China involving collaborative scientific research and exchange of researchers and research information. Future plans for the bureau emphasize the importance of quality control in manufacturing and distribution of oriental medicines.

25. REGULATORY TRENDS -JAPAN Japan has also developed a separated category for natural healthcare products following the Government’s realisation that the cost of healthcare was unsustainable in an aging population Supplements were deregulated to empower consumers to take greater responsibility for their health

26. REGULATORY TRENDS-JAPAN In July 2002 TGA formally handed over the Global Harmonisation Task Force Chair (GHTF) to the Japanese Ministry of health and Welfare. Japan hosted the GHTF conference Total Solutions for Human Healthcare in May 2003. Japan will continue to focus on the important GHTF initiative of governance arrangements

27. INTERNATIONAL REGULATORY TRENDS NATURAL/DIETARY SUPPLEMENT HEALTHCARE PRODUCTS • INCREASE IN REGULATORY PROVISIONS RELATING TO SAFETY, QUALITY AND EFFICACY. • INCREASE HARMONISATION OF INTER-COUNTRY STANDARDS. • GREATER EMPHASISE ON RAW MATERIAL QUALITY AND PRODUCT EFFICACY. • GREATER RECOGNITION OF COMPLEMENTARY/NATURAL HEALTHCARE PRODUCTS IN THEIR OWN RIGHT