Senator DI NATALE (Victoria) (11:57): I move: That this bill be now read a second time. I seek leave to table an explanatory memorandum relating to the bill. Leave granted. Senator DI NATALE: I table an explanatory memorandum and I seek leave to have the second reading speech incorporated in Hansard. Leave granted. The incorporated speech read as follows— THERAPEUTIC GOODS AMENDMENT (PHARMACEUTICAL TRANSPARENCY) BILL 2013 Australia's health system is one of the key responsibilities of government. In the modern age, some of the most crucial components of the health system are the medicines we take. Modern medicines, since the advent of penicillin to the latest gene- or bio-therapy, are one of the key reasons human life spans have increased over the last century. In Australia, thanks to the Pharmaceutical Benefits Scheme, we are fortunate to have easy access to the array of modern medicines that extend our lives and keep us healthy. The $12 billion or so that the Commonwealth spends annually on medicines is a sound and proper investment in the health of the nation. For this investment to be maximised, our medicines must be safe, effective and appropriately and efficiently dispensed to patients. When it comes to safety and efficacy, Australians are fortunate to be well protected. The Therapeutic Goods Administration has an excellent reputation for high standards in regulating the safety of medicines. In terms of cost-effectiveness, the Pharmaceutical Benefits Advisory Committee also sets a world-standard in the evaluation of treatments for public funding. The third component of our medicines system is that which begins when a physician writes a prescription and concludes when the script is filled and paid for - usually by the Commonwealth - at a community pharmacy. Under Australian law, the pharmaceutical industry is forbidden from advertising prescription medicines directly to consumers. The number of prescriptions written for their medicines, and hence the revenues of the pharmaceutical companies, is therefore determined by the number of diagnoses made and prescriptions written by doctors. These companies will naturally take steps to maximise the number of such diagnoses and scripts. It is thus in the interactions between industry and doctors that the potential exists for the integrity of the medicines system to be undermined, and is the reason for this bill. It is appropriate that doctors receive information from pharmaceutical companies. There is much innovation in medicines and the landscape is constantly shifting, so doctors need up-to-date information about new therapies that could help their patients. On the other hand, it is important that doctors remain independent from this industry so that clinical judgement is not affected by commercial pressures. It is unthinkable, for instance, that a doctor should receive a commission on each prescription for a certain medicine, because - consciously or not - that doctor could be expected to be more vigilant for symptoms that correspond with the more lucrative treatment, potentially at the expense of patients with other maladies. On this, the medical profession and the pharmaceutical industry would no doubt strongly agree. The question remains as to where the line should be drawn regarding the interactions between doctors and industry. Where does the greatest potential exist to influence prescribing behaviour unduly? As it happens, there is some good evidence to suggest that there remains a risk of undue influence over prescribing habits. A systematic review that included over 50 studies looked at the impact of pharmaceutical promotion on the quality, quantity, and cost of physicians' prescribing found unambiguously that promotion was associated with more prescriptions, higher costs, and lower prescribing quality. For example, 17 out of 29 studies looking at the impact of visits from pharmaceutical sales representatives found an association between visits and increased prescribing. The authors of this comprehensive review concluded that practitioners should avoid exposure to information from pharmaceutical companies. Not surprisingly the public is also concerned. A survey conducted in 2011 and published in BM1 in February 2012 found that nine in 10 Australians are concerned about the industry's payments to doctors, with over 70910 of respondents worried that payments influence advice to patients. 50% considered the payments a form of bribery. Understandably, the public want to know that the advice they are getting advice from their doctor is based on the best available evidence and not compromised by their doctor's interaction with a drug company. I understand that doctors are time poor and it can be convenient when an "educational opportunity" is offered by a drug company. It may often be the case that there is no more neutral source of information available that a doctor could easily turn to. Doctors naturally doubt that a plane trip or a nice meal would affect their clinical judgement; and this is no doubt true for many or most of them. But the evidence is clear that these things do make a difference. It is simply human nature. When asked, many doctors do admit that such benefits may affect the behaviour of their colleagues. Currently, the industry regulates itself when it comes to these interactions with doctors. The Medicines Australia Code of Conduct was recently updated and approved. The code contains provisions including the requirement to report, in aggregate, payments made to healthcare professional consultants and advisory board members. In some ways, the new Code is a step in the right direction, but it does not go far enough. Some of the Medicines Australia members were willing to go further, for instance Astra2eneca who suggested banning gifts and banning overseas events. But the industry is only willing to go so far. There are other weaknesses with a self-regulation approach. Not all pharmaceutical companies are members of Medicines Australia or consent to abide by the Code Should a member organisation breach the code, the sanctions they face - as designed by their own industry and a body to which they pay dues-are not particularly harsh. This bill places the regulation of commerce between industry and medical professionals in Commonwealth legislation. Under the provisions in the Bill, a pharmaceutical company may not: a) Pay for a medical professional to attend a conference or convention; or pay travel and accommodation costs associated with attending the conference or convention, unless the medical professional is representing the sponsor company and the payments are reported; b) Sponsor an educational seminar or event that is outside Australia when the majority of participants are located in Australia; c) Pay travel or accommodation costs for medical professionals to attend an educational seminar sponsored by the company unless the medical professional is representing the sponsor company and the payments are reported; d) Provide hospitality including meals and entertainment at an educational seminar or other sponsored event with a value of greater than $100 per attendee, or an amount specified in regulation. Furthermore, pharmaceutical companies are obliged to report annually on payments made to doctors, including fees, gifts, honoraria, services such as travel and accommodation, donations or research grants. These reports will name, as individuals, medical practitioners (who are not full-time employees of the company) who receive this largesse. Worldwide, there is considerable momentum for reform in this area. The United States' Sunshine Act contains many similar provisions including those calling for disclosure of the names of doctors on industry payrolls. This bill ensures that the environment in Australia will keep pace with global best practices. It is worth repeating that Australia's health system, including the approval, supply and prescription of drugs works well and is of a standard Australians can be justly proud. In the overwhelming majority of cases, doctors can be expected to act with patients' best interests as their sole concern when prescribing medicines. This bill is not an attack on the integrity of doctors, nor that of the industry. The pharmaceutical industry is, to be sure, a large and very profitable one. But they too are a key part of the health system that keeps us living longer, healthier lives than ever before. This bill will restore trust, integrity and transparency to medicines in Australia. I commend this bill to the Senate. Senator DI NATALE: I seek leave to continue my remarks later. Leave granted; debate adjourned.