Book review - Richard Goldberg, Medicinal Product Liability and Regulation (Hart Publishing, Oxford, 2013) 214pp

In December 2013, settlement was reached between approximately 100 Australian and New Zealand Thalidomide victims and the company which had acted as the Australian distributor of the infamous drug, thus putting to rest the possibility of litigation. Around the same time, Thalidomide victims in the United Kingdom (UK) launched a similar bid for compensation against the manufacturer and distributor. It is clear that despite a lengthy amount of time having passed ever since the thalidomide disaster commenced in 1962, the controversy over compensation continues. Indeed, the author of Medicinal Product Liability and Regulation (published before the announcement of the British legal claim), Professor Goldberg, notes that claims for resulting birth defects continue to emerge right into the present day. His prescient insight into the contemporary relevance of compensation for pharmaceutical injuries thus makes Medicinal Product Liability and Regulation a very relevant addition to the small body of scholarship that is available on this rather specific and complex issue.

Judiciary I Subcommittee on Product Liability report and recommendations, part I.

Cover title.

Product Liability Act : hearings before the Subcomittee on the Consumer of the Committee on Commerce, Science, and Transportation, United States Senate, Ninety-eighth Congress, first session, on S. 44 ....

"S. 44, to regulate interstate commerce by providing for a uniform product liability law, and for other purposes"

Insurance : activity under the Product Liability Risk Retention Act of 1981 : briefing report to the Honorable Edward F. Feighan, House of Representatives.

"B-223648."--p. [1]

An analysis of Australia's legal regime for imposing liability on manufacturers of pharmaceutical drugs

Following a trial in June 2009 where the Federal Court heard submissions regarding whether Merck Sharpe and Dohme Australia should be held liable for an increased risk of cardiovascular conditions noted in patients who had taken the anti-inflammatory drug Vioxx, a judgment was handed down against MSDA in March 2010. MSDA appealed to the Full Federal Court, where they were successful. Special leave to appeal to the High Court of Australia was rejected in May 2012. This article will examine the themes raised in the trial judgment and the appropriateness of Australia’s statutory consumer protection regime through the lens of pharmaceutical drug injuries and side effects.

Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

Adoption of innovative products on Australian road infrastructure projects

Product innovation is an important contributor to the performance of infrastructure projects in the construction industry. Maximizing the potential for innovative product adoption is a challenging task due to the complexities of the construction innovation system. A qualitative methodology involving interviews with major construction project stakeholders is employed to address the research question: ‘What are the main obstacles to the adoption of innovative products in the road industry?’ The characteristics of six key product innovation obstacles in Australian road projects are described. The six key obstacles are: project goal misalignment, client pressures, weak contractual relations, lack of product trialling, inflexible product specifications and product liability concerns. A snapshot of the dynamics underlying these obstacles is provided. There are few such assessments in the literature, despite the imperative to improve construction innovation rates globally in order to deliver road infrastructure projects of increasing size and complexity. Key obstacles are interpreted through an open innovation construct, providing direction for policy to enhance the uptake of innovation across the construction product supply network. Early evidence suggests the usefulness of an open innovation construct that integrates three conceptual lenses: network governance, absorptive capacity and knowledge intermediation, in order to interpret product adoption obstacles in the context of Australian road infrastructure projects. The paper also provides practical advice and direction for government and industry organizations that wish to promote the flow of innovative product knowledge across the construction supply network.

The state of the art defence : defining the Australian experience in the context of pharmaceuticals

One of the defences within Part 3-5 of the Australian Consumer Law is the state of the art, or development risk defence. This defence, although significant, has often been neglected in Australian jurisprudential analysis and has triggered at most generic academic analysis. However, with the rise of pharmaceutical and medical device litigation in Australia, it could become a vital weapon for Australian manufacturers against product liability claims. This paper will firstly review the two ways this defence could operate. It will also discuss the three types of defects which the defence could apply to. This paper aims to determine exactly when and how this defence should apply in Australia, in the context of pharmaceutical product liability claims.

Australian Consumer Law Commentary and Materials [5th Ed.]

"The Australian Consumer Law came into operation on 1 January 2011 as a single national law. It replaced 17 different pieces of Commonwealth, State and Territory legislation relating to consumer protection. Its introduction meant that for the first time, consumers throughout Australia had the same rights and remedies and correspondingly, businesses had the same obligations and responsibilities towards consumers without the barrier of confusing and expensive local variations in the law. Australian Consumer Law: Commentary and Materials contains up-to-date material on the Australian Consumer Law, and in particular the fifth edition incorporates: a revised treatment of unconscionability, taking account of the changes to Part 2-2 of the ACL that became effective in 2012; other State and Federal provisions relating to unfair terms and cases such as Kakavas v Crown Melbourne, ACCC v Lux Distributors, Director of Consumer Affairs v Scully and PT Ltd v Spuds Surf; a comprehensive treatment of the impact of Google v ACCC, Forrest v ASIC and ACCC v TPG – the trilogy of decisions that provide the most recent insights into the High Court’s thinking on aspects of the prohibitions of misleading conduct in the ACL and the Corporations Act 2001; numerous decisions of note; and the possible impact of the Harper Review."--publisher website

Socio-Legal Aspects of the 3D Printing Revolution

Additive manufacturing or ‘3D printing’ has emerged into the mainstream in the last few years, with much hype about its revolutionary potential as the latest ‘disruptive technology’ to destroy existing business models, empower individuals and evade any kind of government control. This book examines the trajectory of 3D printing in practice and how it interacts with various areas of law, including intellectual property, product liability, gun laws, data privacy and fundamental/constitutional rights. A particular comparison is made between 3D printing and the Internet as this has been, legally-speaking, another ‘disruptive technology’ and also one on which 3D printing is partially dependent. This book is the first expert analysis of 3D printing from a legal perspective and provides a critical assessment of the extent to which existing legal regimes can be successfully applied to, and enforced vis-à-vis, 3D printing.

A proteção jurídica dos dados clínicos de testes em medicamentos para humanos

A discussão jurídica versa acerca da proteção ou não dos dados clínicos e informações não divulgadas Data Package, obtidos através de pesquisas clinicas, a partir do desenvolvimento de um novo medicamento. È importante realizar-se uma investigação prévia para descobrir se o novo medicamento a ser comercializado, possui efeitos benéficos ou adversos, que possam afetar os seres humanos, garantindo assim a eficácia e a segurança de sua utilização. O dossiê contendo os dados clínicos é submetido à Agência Nacional de Vigilância Sanitária que, no uso de sua atribuição específica, e em função da avaliação do cumprimento de caráter jurídico-administrativo e técnico-científico relacionado com a eficácia, segurança e qualidade do medicamento conforme a Lei 6360/76 e o Decreto 79.094/77 determina o registro sanitário. A tese defendida pelas sociedades farmacêuticas de pesquisa é a de que seria vedado à ANVISA deferir registros de medicamentos genéricos e similares de mesmo princípio ativo, com base nas pesquisas clinicas realizada, enquanto vigente o período de exclusividade, com fundamento no artigo 5, inciso XXIX da Constituição Federal, artigos 39.1, 39.2, 39.3 do Acordo sobre Aspectos dos Direitos de Propriedade Intelectual Acordo TRIPS, artigo 195, XIV da Lei n 9.279/96 (Lei da Propriedade Industrial), artigo 421, 884, 885 e 886 do CC, artigo 37, caput, da CF e artigo 2, da Lei 9.784/99 e aplicação analógica da Lei 10.603/2002. A ANVISA ao permitir aos fabricantes dos medicamentos genéricos e similares a utilização do pacote de dados clínicos, fornecido pelo titular do medicamento de referencia, estaria promovendo a concorrência desleal e parasitária, ao permitir que as versões genéricas e similares, ingressem no mercado, sob custos de produção e comerciais substancialmente menores, do que os praticadas pelos medicamentos de referencia. Este argumento tem fulcro na norma do artigo 39.3 do Acordo TRIPS firmado entre os membros da Organização Mundial do Comércio OMC, em 1994, no qual o Brasil é signatário, e que se comprometeram a adotar providências no sentido de manter em sigilo e protegidos contra o uso comercial desleal os dados clínicos relativos à pesquisa clínica, necessários à aprovação da comercialização de produtos farmacêuticos. A divulgação, exploração ou a utilização dos dados clínicos, sem a autorização do respectivo titular, o qual demandou recursos materiais e humanos consideráveis e desde que estas informações tenham sido apresentadas a entidades governamentais como condição para aprovação da comercialização de um medicamento, devem ser protegidas. Os Estados membros da OMC e subscritores do acordo internacional devem assegurar que os concorrentes não tenham acesso às informações recebidas pelo ente estatal, que não as explorarem ou delas possam aferir indevidamente tanto direta quanto indiretamente de vantagens que as beneficiem do conhecimento técnico-cientifico, investimentos e esforços realizados pelo titular daquela pesquisa clínica. Dentro deste cenário, faz-se necessário que o Estado produza um marco regulatório capaz de prover uma segurança jurídica, que permita as sociedades farmacêuticas disponibilizar elevado investimento, viabilizando a realização de pesquisa clinica e introdução de novos medicamentos.

The imminent availability of a potent weight-loss medicine in pharmacies: public perception of effectiveness

Orlistat is an effective weight-loss medicine, which will soon be available for purchase in pharmacies. We used a factorial experiment and found that informing people about the availability for purchase of this medicinal product previously only available on prescription resulted in higher ratings of perceived value and effectiveness compared to a natural health supplement even though we used the same statement about effectiveness. This positive perception of orlistat was not impaired by the provision of side-effect information. Orlistat will soon be available in pharmacies. Health professionals must act to prevent its misuse by those not overweight.

Comparative therapeutic use of Risedronate and Calcarea phosphorica - Allopathy versus homeopathy - In bone repair in castrated rats

Osteoporosis, a disease characterized by progressive bone loss, has been the target of several studies in the past few years. It results in a much higher risk for fractures and might cause slower bone lesion healing. The aim of this work was to study the effects of Risedronate (allopathic medicine) and Calcarea phosphorica 6CH (homeopathic medicine) on the repair of bone lesions in male rats with osteoporosis induced by castration. Eighty-four three-month-old rats were used divided into four groups of twenty-one animals each. Three groups where castrated and one group was submitted to Sham surgery. One month later, cortical lesions were made in all animals' tibiae and, after one day, the different experimental treatments began according to the following groups: CR - castrated/Risedronate (1 mg/kg/day); CCp - castrated/ Calcarea phosphorica 6CH (3 drops/day); CP - castrated/placebo and SP - Sham/placebo. The animals were sacrificed at seven, fourteen and twenty-eight days after the beginning of the treatments and had their tibiae removed. Digital radiographs of the tibiae were taken and analyzed in order to evaluate the optical density of the defect area. Then, they were decalcified and processed for histological and histomorphometrical analysis. The data were submitted to ANOVA, and to the Tukey and Dunnett tests (5%). The allopathic and homeopathic treatments led to different bone formation as regards remodeling and maturation aspects. Further research is necessary to access the resistance and quality of the newly formed bone.

Profile of Maytenus aquifolium action over free radicals and reactive oxygen species

Reactive oxygen species (ROS) and free radical species have been implicated in initiating, accompanying or causing many diseases in living organisms; there is thus, a continual need for antioxidants molecules to inactivate ROS/free radicals. Many studies of plants crude extracts have demonstrated free-radical scavenging and antioxidant action. Maytenus species have long been used, in several countries, as traditional medicines against gastric ulcers, dyspepsia and others gastric problems and for their anti-inflammatory properties. In this study, Maytenus aquifolium (Celastraceae) root bark ethanol extract was assessed for its ability to scavenge free radicals and reactive oxygen species. The results were expressed as percentage inhibition of the active species. The extract was efficient against studied reactive species: DPPH radical (obtained inhibition = 35.5 ± 1.3 %), ABTS.+ (IC50 = 0.0036 ± 0.0003 mg/mL), HOCl (IC50 = 0.002 ± 0.0001 mg/mL), O2 .- (obtained inhibition = 36.0 ± 2.1 %), and NO. (obtained inhibition = 18.3 ± 0.4 %). Uniterms Oxidant species Free radicals Maytenus aquifolium Oxidative damage.

Pharmacognostical evaluation of fruits of Solanum lycocarpum A. St.-Hill. (Solanaceae)

This study describes the chemical and physical-chemical profile of plant drug and ethanolic extract obtained from fruits of Solanum lycocarpum A. St.-Hill. (Solanaceae). The physical and chemical analysis involved the granulometry determination, non-compacted apparent density, loss on drying in oven and in infrared scale, pH, ash values and extractive values. The results determined the physical-chemical characteristics of the drug plant. It was also carried out the microbiological control of the plant drug. The preliminary phytochemical screening featured the presence of tannins, flavonoids and saponins in the plant drug and alkaloids and steroids in the ethanolic exctract. The solamargine and solasonine glycoalkaloids were identified through TLC and GC/ MS. The levels of total phenols and tannins were quantified in the extract (8.90% and 6,85% respectively). Such studies contribute to the chemical identification and quality control of S. lycocarpum fruits. © 2010 Phcog.net.