Competition policy: consequences of restrictive trade practices and price-fixing provisions for medical practitioners in Australia and New Zealand

Competition laws have only applied to many participants in the health care industry in Australia and New Zealand since the mid 1990s. Since then, the Australian Competition and Consumer Commission has considered a number of applications by medical practitioner associations and private hospitals to authorise potentially anti-competitive conduct, while the New Zealand Commerce Commission has successfully prosecuted a group of ophthalmologists. Amongst medical practitioners, however, there is still confusion and misunderstanding concerning the type of conduct caught by the Australian Trade Practices Act 1974 (Cth) and the New Zealand Commerce Act 1986 (NZ). This is of serious concern given the substantial penalties associated with price-fixing and restrictive trade practices. This article examines the provisions of these Acts most relevant to medical practitioners as well as a number of determinations and judicial decisions. To provide practical assistance to medical practitioners, the key lessons are extracted.     

The Effect of Lowering the Legal Drink‐Drive Limit on the Toxicological Findings in Driver Fatalities: A Comparison of Two Jurisdictions,

In December 2014, the legal blood alcohol limit for drivers in both Scotland and New Zealand was reduced from 80 to 50 mg/100 mL. This paper reports a retrospective study comparing changes in the toxicological findings in deceased drivers and motorcyclists before and after the limit change in both jurisdictions. A year of fatal motor vehicle crashes prior to and following the limit change is examined for both countries. In Scotland, there was an increase in drug prevalence among fatally injured drivers and motorcyclists, with the use of all drug groups increasing after the limit change, with the exception of cannabinoids. In New Zealand, there was a reduction in cases involving drugs only, but increases in the numbers of deceased drivers and motorcyclists positive for alcohol only and co‐using alcohol and drugs.     

The collation of forensic DNA case data into a multi-dimensional intelligence database

The primary aim of any DNA Database is to link individuals to unsolved offenses and unsolved offenses to each other via DNA profiling. This aim has been successfully realised during the operation of the New Zealand (NZ) DNA Databank over the past five years. The DNA Intelligence Project (DIP), a collaborative project involving NZ forensic and law enforcement agencies, interrogated the forensic case data held on the NZ DNA databank and collated it into a functional intelligence database. This database has been used to identify significant trends which direct Police and forensic personnel towards the most appropriate use of DNA technology. Intelligence is being provided in areas such as the level of usage of DNA techniques in criminal investigation, the relative success of crime scene samples and the geographical distribution of crimes. The DIP has broadened the dimensions of the information offered through the NZ DNA Databank and has furthered the understanding and investigative capability of both Police and forensic scientists. The outcomes of this research fit soundly with the current policies of 'intelligence led policing', which are being adopted by Police jurisdictions locally and overseas.     

Dilemmas for clinicians in use of Community Treatment Orders

Clinicians who treat patients using Community Treatment Orders (CTOs) face many potential dilemmas in their relations with involuntary outpatients and the exercise of their powers. We compare the dilemmas identified in the literature with those reported by responsible clinicians in New Zealand (NZ). These clinicians experienced a number of well-known dilemmas, such as determining the right moment for a person's discharge from a CTO, but they seemed less troubled by some other difficulties than might be expected, usually because they considered involuntary outpatient treatment the best option for the patient or the best way to manage the risks involved. Further dilemmas were identified by the NZ clinicians that have not been widely discussed, concerning the proper scope of clinical authority over patients under CTOs and the decision to revoke involuntary outpatient status. In conclusion, some suggestions are made as to how clinicians might best manage the dilemmas involved.     

Forensic Analysis of Explosives Using Isotope Ratio Mass Spectrometry (IRMS)—Part 2: Forensic Inter-Laboratory Trial: Bulk Carbon and Nitrogen Stable Isotopes in a Range of Chemical Compounds (Australia and New Zealand)

Abstract:  Comparability of data over time and between laboratories is a key issue for consideration in the development of global databases, and more broadly for quality assurance in general. One mechanism that can be utilized for evaluating traceability is an inter-laboratory trial. This paper addresses an inter-laboratory trial conducted across a number of Australian and New Zealand isotope ratio mass spectrometry (IRMS) laboratories. The main objective of this trial was to determine whether IRMS laboratories in these countries would record comparable values for the distributed samples. Four carbon containing and four nitrogen containing compounds were distributed to seven laboratories in Australia and one in New Zealand. The laboratories were requested to analyze the samples using their standard procedures. The data from each laboratory was evaluated collectively using International Standard ISO 13528 ( Statistical methods for use in proficiency testing by inter-laboratory comparisons ). "Warning signals" were raised against one participant in this trial. "Action signals" requiring corrective action were raised against four participants. These participants reviewed the data and possible sources for the discrepancies. This inter-laboratory trial was successful in providing an initial snapshot of the potential for traceability between the participating laboratories. The statistical methods described in this article could be used as a model for others needing to evaluate stable isotope results derived from multiple laboratories, e.g., inter-laboratory trials/proficiency testing. Ongoing trials will be conducted to improve traceability across the Australian and New Zealand IRMS community.     

Culling bad apples, blowing whistles and the Health Practitioners Competence Assurance Act 2003 (NZ)

The Health Practitioners Competence Assurance Act 2003 (NZ) became New Zealand law on 18 September 2003. This article looks at the background to the Act and reasons for resistance to it. It discusses the record so far on the medical profession's self-regulation of fitness-to-practise issues and the legal duties of practitioners who have reason to believe a colleague is putting patients at risk. It looks at some of the changes the Act brings, compares the experience of English and American medico-legal reforms, where applicable, and attempts to draw some conclusions on the chances for successful change.     

Ancestry and BMI Influences on Facial Soft Tissue Depths for A Cohort of Chinese and Caucasoid Women in Dunedin,New Zealand

This study measured and assessed facial soft tissue depths (FSTDs) in adult female Chinese and New Zealand (NZ) Europeans (Caucasoids). Ultrasound was used to obtain depths at nine landmarks on 108 healthy subjects (51 Chinese, 57 NZ European), erect positioned, of same age group (18–29 years). Height and weight were also recorded. Statistical analysis focused on comparison of tissue depth between the two ancestry groups and the influence of Body Mass Index (BMI) (kg/m²). Results showed mean depth differences at Supra M2 and Infra M2 landmarks significantly greater for Chinese than Caucasoid women for all three BMI Classes (BMI <20, 20 ≤ BMI < 25, 25 ≤ BMI < 30), even BMI <20. For both groups BMI positively correlated with FSTD values at all landmarks except Labrale superius. This study enabled ancestry and BMI influence on FSTDs to be observed and compared for two distinct groups. Results add to knowledge about facial tissue depth variation.     

Quantitative analysis of methamphetamine in hair of children removed from clandestine laboratories--evidence of passive exposure?

In New Zealand many children have been removed from clandestine laboratories following Police intervention. In the last few years it has become standard procedure that these children have hair samples taken and these samples are submitted to the laboratory for analysis. There are various mechanisms for the incorporation of drugs into hair. The hair follicle has a rich blood supply, so any drug that may be circulating in the blood can be incorporated into the growing hair. Another mechanism is via external contamination, such as spilling a drug on the hair or through exposure to fumes or vapours. Hair samples were analysed for methamphetamine and amphetamine. From the 52 cases analysed 38 (73%) were positive for methamphetamine (>0.1 ng/mg) and amphetamine was detected in 34 of these cases. In no case was amphetamine detected without methamphetamine. The hair washes (prior to extraction) were also analysed (quantified in 30 of the positive cases) and only 3 had a wash to hair ratio of >0.1 (all were <0.5), which may be indicative of a low level of external contamination. This low level of evidence of external contamination suggests that the children are exposed to methamphetamine and are incorporating it into the hair through the blood stream.     

New "party pill" components in New Zealand: the synthesis and analysis of some β-ketone analogues of 3,4-methylenedioxymethamphetamine (MDMA) including βk-DMBDB (β-ketone-N,N-dimethyl-1-(1,3-benzodioxol-5-yl)-2-butanamine)

In 2008, the New Zealand Government passed an amendment to reschedule what were, at the time, the active ingredients of 'party pills' in New Zealand. Since then, submissions of tablets and powders to the Institute of Environmental Science and Research (ESR) Limited have included ingredients not previously seen among drug seizures in New Zealand. These new components, confirmed by the synthesis of standards, included some beta-ketone (βk) analogues of 3,4-methylenedioxyamphetamine (MDA). Though not yet seen in tablet or powder seizures, the synthesis and the analytical data for βk-DMBDB ((beta-ketone)-N,N-dimethyl-1-(1,3-benzodioxol-5-yl)-2-butanamine) are reported here for the first time.     

AIDS drugs & the pharmaceutical industry: a need for reform.

The pharmaceutical industry has long enjoyed substantial profits despite increased requirements for drug approval and various attempts to regulate the industry. Drug companies have avoided effective regulation by blaming high prices on the costs of research and development. The search for drugs effective in combatting HIV and AIDS related illnesses has provided a stark background on which to view the actions and justifications of drug companies. Despite increased cooperation between government and the drug industry and expedited approval of several useful drugs, these drugs are still prohibitively expensive. This Article explores the history and economics of the drug industry and proposes a system of national price regulation for all drugs.     

The uncritical enthusiasts versus the uninformed sceptics: regulation of complementary and alternative medicines

The introduction of a treaty between Australia and New Zealand to regulate complementary and alternative medicines (CAM) has revived the age-old debate between advocates of conventional medicine and those of CAM, particularly with regard to the standards of regulation that should be applied. Currently, the systems for regulating CAM products in Australia and New Zealand are very different, making harmonisation contentious, as the proposed treaty follows the Australian system very closely. New Zealand and Australian principles of good regulatory practice stipulate that only minimum necessary standards should be imposed, and should be transparent, understandable and equitable. It is argued that the proposed treaty does not adhere to good regulatory standards, and that other forms of harmonisation should be sought to avoid adopting a regulatory regime in New Zealand that is overly restrictive and harmful to the New Zealand CAM industry.     

Determination of tramadol in hair using solid phase extraction and GC-MS

Tramadol is a centrally acting synthetic analgesic with mu-opioid receptor agonist activity, it is a widely prescribed analgesic used in the treatment of moderate to severe pain and as an alternative to opiates. Tramadol causes less respiratory depression than morphine at recommended doses. Its efficacy and low incidence of side effects lead to its unnecessary prescribing in patients with mild pain. Tramadol was classified as a "controlled drug" long after its approval for use in Jordan. Analysis of drugs of abuse in hair has been used in routine forensic toxicology as an alternative to blood in studying addiction history of drug abusers. A method for the determination of tramadol in hair using solid phase extraction and gas chromatography-mass spectrometry (GC-MS) is presented, the method offers excellent precision (3.5-9.8%, (M)=6.77%), accuracy (6.9-12%, M=9.4%) and limit of detection 0.5 ng/mg. The recovery was in the range of 87-94.3% with an average of 90.75%. The calibration curve was linear over the concentration range 0.5-5.0 ng/mg hair with correlation coefficient of 0.998. The developed method was tested on 11 hair samples taken from patients using tramadol as prescribed by their physician along with other different drugs in treating chronic illnesses. Tramadol was detected in all hair samples at a concentration of 0.176-16.3 ng/mg with mean concentration of 4.41 ng/mg. The developed method has the potential of being applied in forensic drug hair testing. In Jordan, hair drug testing started to draw the attention of legal authorities which stimulated forensic toxicologists in recent years to develop methods of analysis of drugs known or have the potential to be abused.     

Long-term stability of various drugs and metabolites in urine, and preventive measures against their decomposition with special attention to filtration sterilization

The long-term stability of drugs and metabolites of forensic interest in urine, and preventive measures against their decomposition have been investigated, with special attention to filtration sterilization. An aseptic urine collection kit, which was recently developed based on filtration sterilization, was utilized for the aseptic collection and storage of urine samples. For evaluating preservation measures, methamphetamine (MA), amphetamine (AP), nitrazepam (NZ), estazolam (EZ), 7-aminoflunitrazepam (7AF), cocaine (COC), and 6-acetylmorphine (6AM) were spiked into urine at 500 ng/mL each, and were monitored for 6 months at 25, 4, and -20 degrees C, after the addition of NaN(3) and/or filtration sterilization using the aseptic collection kit. In severely contaminated urine with bacteria, there were significant losses of 7AF and NZ, and slight decomposition of MA and AP at 25 degrees C. However, such degradation was successfully suppressed by the use of the kit, though the use of the kit and NaN(3) were preferred for 7AF. The kit was also effective in preventing the hydrolyses of COC and 6AM, while it was suggested that the common preservative NaN(3) can accelerate the hydrolysis of such ester-type drugs and metabolites.     

PARALLEL IMPORTATION AND SERVICE QUALITY: AN EMPIRICAL INVESTIGATION OF COMPETITION BETWEEN DVDS AND CINEMAS IN NEW ZEALAND

Investigations into the causes and effects of parallel importinghave concentrated on price discrimination, but arbitrage canalso occur on non-price dimensions. Using a natural experimentin the New Zealand film distribution industry between May 1998and November 2001, we examine the effect of parallel importingon quality as it relates to the timing of the availability offilm media. We demonstrate that (a) cinema revenues were underminedas consumers substituted viewing films on parallel importedDVDs for the cinema format and (b) that studios responded tothe threat of parallel imported DVDs by bringing forward therelease of films into New Zealand cinemas. The reduced delaybetween US and New Zealand cinematic release dates is shownto be consistent with the introduction of competition when timingis a dimension of quality and choice. We conclude that parallelimportation of DVDs almost certainly resulted in a net increasein welfare in New Zealand.     

Changing patterns of drug and alcohol use in fatally injured drivers in Washington State

We have previously reported on patterns of drug and alcohol use in fatally injured drivers in Washington State. Here we revisit that population to examine how drug use patterns have changed in the intervening 9 years. Blood and serum specimens from drivers who died within 4 h of a traffic accident between February 1, 2001, and January 31, 2002, were analyzed for illicit and therapeutic drugs and alcohol. Drugs when present were quantitated. Samples suitable for testing were obtained from 370 fatally injured drivers. Alcohol was detected above 0.01 g/100 mL in 41% of cases. The mean alcohol concentration for those cases was 0.17 g/100 mL (range 0.02-0.39 g/100 mL). Central nervous system (CNS) active drugs were detected in 144 (39%) cases. CNS depressants including carisoprodol, diazepam, hydrocodone, diphenhydramine, amitriptyline, and others were detected in 52 cases (14.1%), cannabinoids were detected in 47 cases (12.7%), CNS stimulants (cocaine and amphetamines) were detected in 36 cases (9.7%), and narcotic analgesics (excluding morphine which is often administered iatrogenically in trauma cases) were detected in 12 cases (3.2%). For those cases which tested positive for alcohol c. 40% had other drugs present which have the potential to cause or contribute to the driver's impairment. Our report also considers the blood drug concentrations in the context of their interpretability with respect to driving impairment. The data reveal that over the past decade, while alcohol use has declined, some drug use, notably methamphetamine, has increased significantly (from 1.89% to 4.86% of fatally injured drivers) between 1992 and 2002. Combined drug and alcohol use is a very significant pattern in this population and is probably overlooked in DUI enforcement programs.     

Drug problems in China: recent trends, countermeasures, and challenges

Drug crime in China is on an overall rising trend. Major drug crime cases are becoming more common, the types of drugs being trafficked are more diverse, and the smuggling and trafficking of drugs into the country and the smuggling of precursor chemicals out of the country have formed a bidirectional cycle. Drug crimes in China have also begun to show a conspicuous trend of internationalization. China's main countermeasures against drug crimes have been to pass new laws and regulations against drugs, to increase the efforts to eradicate cultivation, to establish and expand "drug-free communities" programs, and to strengthen international cooperation in antidrug campaigns. The existing problems demand prompt solutions, which include a shortage of funding and lack of accurate knowledge about prevalence of drug abuse and related data for scientifically studying the drug problems.     

The Finnish legislation on workplace drug testing

In Finland, the Act on the Protection of Privacy in Working Life (759/2004) that entered into force in 2004 incorporates provisions related to drug use testing, e.g. on the employers' right to process in certain situations information on job applicants' and employees' drug use. In the same context, provisions were added to the Occupational Health Care Act (1383/2001) on the employer's obligation to draw up, together with the staff, a written programme dealing with alcohol and drugs for the workplace. The programme defines the overall objectives for and the practices to be observed at the workplace in order to prevent substance abuse and to refer the problem users to treatment. The Occupational Health Care Act also includes provisions on drug tests and the drug test certificate as well as on reimbursement of the expenses of drug tests. Furthermore, the Act lays down a definition of drug tests. Every workplace shall have a plan/programme on drug-free workplace, where the jobs in which the workers have to present a drug test certificate to the employer must be defined. This plan/programme shall be discussed in cooperation on tripartite basis at the workplace. A Government decree on drug use testing (218/2005) has been issued in virtue of the Occupational Health Care Act. It lays down provisions on the practical performance of drug tests, i.e. taking and analysis of samples, and interpretation of the test results. The purpose of the Government decree is to ensure that workplace drug testing is carried out in a way presupposed by a good occupational health care practice and the laboratory quality standards, taking into account the integrity and protection of privacy of the persons tested as well as their other fundamental rights.     

Legal, workplace, and treatment drug testing with alternate biological matrices on a global scale

Global trends in drug trafficking and drug usage patterns indicate a continuing pattern of escalation throughout the world. Over the last two decades, urinalysis has evolved into a highly accurate means for determining whether individuals have been exposed to illicit drugs of abuse. Advances have also been made in the use of alternate biological matrices such as hair, oral fluids and sweat for drug testing. Often, these new matrices demonstrate some distinct advantages over urinalysis, e.g. less invasive procedures, different time course of drug detection. They may even indicate impairment. National and local laws of each country provide the underpinnings of drug-testing programs, but most countries have not addressed use of these alternate matrices. Currently, only a few countries have statutes that specifically mention use of alternate biological matrices, e.g. United States (Florida state law), Germany, Ireland, Poland and the Czech Republic. Conversely, few countries have prohibited collection of alternate biological specimens or drug test devices that utilize such specimens. In addition, guidelines for implementing drug testing programs have been slow to emerge and most deal primarily with workplace drug testing programs, e.g. United States. Currently, scientific technology utilized in drug testing is advancing rapidly, but there is a clear need for parallel development of guidelines governing the use of alternate matrices for drug testing. This article provides an overview of global drug trafficking patterns and drug use, and results from a survey of legal statutes in 20 countries covering use of alternate matrices for drug testing. In addition, elements needed for the development of guidelines for alternate matrices testing for drugs of abuse are discussed, and specific examples of use of alternate matrices in treatment monitoring are provided.