Medical Innovation Bill- PMB 1-2014 Introductory Remarks

1. MEDICAL INNOVATION BILLPMB 1 - 2014Presentation toMembers of the Portfolio Committee on Health17 September 2014byMr Narend Singh, MP

2. Medical Innovation Bill- PMB 1-2014Introductory Remarks Cancer is a major global burden. The latest statistics predict it will affect 1 in 3 people and it remains the leading cause of death worldwide. Cancer not only costs billions of dollars each year to treat, but more importantly affects the quality of life for patients and their families Around the world, and in South Africa in particular, people have expressed their desire for new, effective and affordable treatments. Exciting new integrative therapies are being discovered daily however ‘red tape’ often prevents them from getting to patients in a timely manner. Most take over 10 years to get from the research stage to the patient, a time during which too many cancer sufferers die. Despite the tremendous ongoing efforts of doctors and scientists around the world, there is no cure yet for cancer. Our world has changed. Scientists and doctors alike are now looking in new directions. The practice of using integrative medicine to treat illness and disease by combining alternative medicine with conventional medicine is the way of the future. It includes treating the whole person by focusing on wellness and health as well as treating the disease and palliative care.

3. Medical Innovation Bill- PMB 1-2014Background Under current legislation medical practitioners are being legally prevented from prescribing and administering effective and harmless treatments, including those involving the use of cannabis, with respect to several life threatening diseases, including cancer, because such treatments have not been approved in terms of presently legally required double-blind in vivo clinical studies. However, such clinical studies are often economically unviable, as the treatment or the substances used for it, such as bicarbonate of sodium or cannabis, are in the public domain and not capable of been patented, thereby preventing any relevant party from recouping the costs of such studies from future profits. This results in unnecessary human suffering and death on a mass scale, with consequent immense social and economic costs.

4. Medical Innovation Bill- PMB 1-2014Objectives The objectives of the Bill are to establish one or more research centres or hospitals where medical innovation can take place especially with regard to the treatment and cure of cancer; and to legalize the medical, commercial and industrial use of cannabis in accordance with emerging world standards. The Bill creates a special legal dispensation, which applies only in research pilot hospitals authorized by the Minister of Health where medical practitioners are granted greater professional discretion to administer innovative and alternative medical treatments on the basis of the patients’ informed consent.

5. Medical Innovation Bill- PMB 1-2014Proposals The Medical Innovation Bill proposes amendments to the health policy and laws of South Africa with respect to the treatment of cancer and other incurable diseases. These changes would allow doctors to administer conventional treatments along with innovative complementary therapies and treatment options. It would also empower the Minister of Health to establish one or more medical treatment research centres, where doctors would be allowed, under strict control and regulation, to administer these therapies.

6. Medical Innovation Bill- PMB 1-2014Legal • The Bill was first published in the Government Gazette of the 18th February 2014; • Then introduced in the National Assembly by Dr Mario Oriani-Ambrosini, MP, on the 20th February, 2014; • The Bill then lapsed in accordance with National Assembly Rules at the end of the 4th Parliament, and was revived, without opposition at the beginning of the 5th Parliament; • Upon the passing of Dr Oriani-Ambrosini, MP, the Bill once again lapsed; • It was subsequently adopted and re-introduced by Mr Narend Singh, MP and soon thereafter revived by motion of the Chief Whip of the Ruling Party, and again with no objection from any other political party in the National Assembly;

7. Medical Innovation Bill PMB 1 -2014Long Title • “To Make provision for innovation in medical treatment and to legalize the use of cannabinoids for medical purposes and beneficial commercial and industrial uses.”

8. Medical Innovation Bill PMB 1 -2014Purpose • The purposes of this Bill are to - • codify existing best-practices to allow decisions by medical practitioners to innovate in cases where evidence-based treatment or management is not optimal or appropriate, because the available evidence is insufficient or uncertain; • enhance certainty and clarity for medical practitioners and others regarding the criteria to be applied in determining whether to innovate in the cases referred to in subsection (1); • encourage responsible innovation in medical treatment and management by supporting reasonable and logical clinical decisions; • deter reckless, illogical and unreasonable departure from standard practice; and • legalize and regulate the use of cannabinoids for medical purposes and for beneficial commercial and industrial uses.

9. Medical Innovation Bill- PMB 1-2014Public Support The Bill has to date, garnered unprecedented public support from South Africans and the International Community at large. Over 1903 comments have thus far been received in unanimous broad support of the Bill;

10. Medical Innovation Bill- PMB 1-2014Existing ‘Cannabis’ Regulation The Netherlands Canada Germany Israel Australia Great Britain Portugal Uruguay United States Spain North Korea France Austria Belgium Czech Republic

11. Medical Innovation Bill PMB 1 -2014Conclusion We have here before us, an opportunity to place South Africa on the world stage as leaders in medical innovative practices and I submit, the solemn responsibility, to help the thousands upon thousands of South Africans who otherwise would not have access to options in cancer and other dread disease treatment and care.

12. Medical Innovation Bill PMB 1 -2014Closing Remarks“Death is something inevitable. When a man has done what he considers to be his duty to his people and his country, he can rest in peace. I believe I have made that effort and that is, therefore, why I will sleep for the eternity.” - Nelson Mandela I believe, we have a duty to the many thousands of suffering and terminally-ill people in South Africa. The ones who have no hope left, the ones who have been told by their doctors “to go home and die quietly,” to give them a fighting chance, which is what this Bill is, in essence, all about.I thank you.Mr Narend Singh, MP