Burden of non-communicable diseases (NCDs) in Nepal and the availability and affordability of NCD medicines

Background: Traditionally communicable diseases were the main causes of burden in developing countries like Nepal. In recent years non-communicable diseases (NCDs), mainly cardiovascular diseases (CVDs), cancer, chronic respiratory diseases and diabetes mellitus, impose a larger disease burden compared to communicable diseases. Most elements of health and medicine policies in Nepal are still focused on communicable diseases. There is limited evidence about NCDs and NCD medicines in Nepal. Aim: To explore the gap between the burden of NCDs and the availability and affordability of NCD medicines in Nepal. Methods: Biomedical databases like Medline, Scopus, Web of Science and other online sources (including Global Burden of Diseases data) were searched for data on the burden of NCDs in term of Disability Adjusted Life Years (DALYs). The Essential Medicines List (EML) of Nepal was compared with World Health Organisation (EML) for inclusion of NCD medicines. Results: In Nepal, NCDs caused nearly 45% of the total 10.5 million DALYs in 2010. CVDs (15.2%), were the leading cause of NCDs burden followed by chronic respiratory diseases (14.7%), cancer (7.3%) and diabetes mellitus (3.2%). One hospital based national survey found that 37% of hospitalised patients had NCDs. Among them, 38% had heart disease followed by COPD (33%) , and diabetes (10%). Most (23 out of 28) non-cancer NCD medicines recommended in WHO-EML were present in Nepal's EML, theoretically indicating good availability. However, it is difficult to say whether they are accessible and affordable due to the lack of adequate data on access and pricing. Conclusion: This study gives some insight into the burden of NCDs. Although NCD medicines are available in Nepal, further research is required to determine whether they are accessible and affordable to the general population.

Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

Australian patent enforcement : a proposal for an expert panel opinion

The Australian Government has been concerned “to find ways of making patent enforcement less of an issue” and to make it “cheaper, simpler and quicker to get fair and appropriate resolution for any dispute”. Major problems relating to patent enforcement in Australia have been identified as: the cost of legal proceedings; the lack of patent owners’ financial capacity to fund enforcement proceedings; delay; and uncertainty as to the outcome and lack of knowledge about the processes of enforcement. This paper considers some of the problems associated with patent enforcement in Australia and proposes an approach to patent litigation which is directed at alleviating some of the difficulties which have been identified. Specifically, it proposes a strategy designed to identify the parties’ risks at an early stage of patent litigation proceeding and facilitate an early resolution of the dispute.

Pharmaceutical company influences on medication prescribing and their potential impact on quality use of medicines

Background Pharmaceuticals are big business, reporting strong market growth year after year. The ‘gatekeepers’ of this market are prescribers of medicines, who are the major target of pharmaceutical companies, utilizing direct and indirect influences. Methods This paper draws on previous research investigating pharmaceutical company prescribing influences to develop a qualitative model demonstrating the synergism between commercial influences on prescribing. The generic model was used to explore a realistic but hypothetical scenario to ascertain the applicability of the model. Results and Discussion A generic influence model was developed. The model was readily able to be adapted to reflect a realistic practice scenario. Conclusion Prescriber awareness of the linkages between various seemingly separate marketing techniques could potentially improve medicines usage in an evidence-based practice paradigm.

Community pharmacy dispensing of prescription medicine sample packs: Changing the business of medicine initiation?

Prescription medicine samples (or starter packs) are provided by pharmaceutical manufacturers to prescribing doctors as one component in the suite of marketing products used to convince them to prescribe a particular medicine [1,2]. Samples are generally newer, more expensive treatment options still covered by patent [3,4]. Safe, effective, judicious and appropriate medicine use (quality use of medicines) [5] could be enhanced by involving community pharmacists in the dispensing of starter packs. Doctors who use samples show a trend towards prescribing more expensive medicines overall [6] and also prescribe more medicines [7]. Cardiovascular health and mental health are Australian National Health Priority Areas [8] and account for approximately 30% and 17%, respectively, of annual government Pharmaceutical Benefits System (PBS) in 2006 [9]. The PBS is Australia's universal prescription subsidy scheme [9]. Antihypertensives were a major contributor to the estimated 80 000 medicine-related hospital admissions in Australia in 1999 [10] and also internationally [11,12]. The aim of this study was to pilot an alternative model for supply of free sample or starter packs of prescription medicines and ascertain if it is a viable model in daily practice.

Repeatability or reproducibility in Australian Patent Law

This article considers the extent to which a claimed process must be repeatable or reproducible in order to be patentable according to Australian patent law. It asks whether a process must yield identical or near-identical results each time the process is invoked, or if not, what degree of repeatability is required. The question is relevant when considering, among other things, the patentability of some methods of medical treatment and diagnosis, biotechnology inventions and business methods.

Teaching and assessment of prescribing medicines : how does pharmacy perform?

BACKGROUND Prescribing is a complex task, requiring specific knowledge and skills combined with effective, context-specific clinical reasoning. Prescribing errors can result in significant morbidity and mortality. For all professions with prescribing rights, a clear need exists to ensure students graduate with a well-defined set of prescribing skills, which will contribute to competent prescribing. AIM To describe the methods employed to teach and assess the principles of effective prescribing across five non-medical professions at Queensland University of Technology. METHOD The NPS National Prescribing Competencies Framework (PCF) was used as the prescribing standard. A curriculum mapping exercise was undertaken to determine how well the PCF was addressed across the disciplines of paramedic science, pharmacy, podiatry, nurse practitioner and optometry. Identified gaps in teaching and/or assessment were noted. RESULTS Prescribing skills and knowledge are taught and assessed using a range of methods across disciplines. A multi-modal approach is employed by all disciplines. The Pharmacy discipline uses more tutorial sessions to teach prescribing principles and relies less on case studies and clinical appraisal to assess prescribing when compared to other disciplines. Within the pharmacy discipline approximately 90% of the PCF competencies are taught and assessed. This compares favourably with the other disciplines. CONCLUSION Further work is required to establish a practical, effective approach to the assessment of prescribing competence especially between the university and clinical settings. Effective and reliable assessment of prescribing undertaken by students in diverse settings remains challenging.

Is Australia positioned to take advantage of biosimilars?

Australia currently has a small generic and biosimilar industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial confidential information, and in remuneration. These improvements, together with Australia’s geographical proximity and strong trade relationship with the Asian biocluster have positioned Australia to take advantage of potential public cost savings from the increased use of biosimilars.

Medicines related dysphagia in primary care: The prevalence of and impact on community pharmacists

Dysphagia is a common and problematic symptom characterised by varying degrees of difficulty swallowing food, fluids and medicines of differing consistencies. International primary care based studies have identified that between 1 in 4 and 1 in 5 patients have some form of dysphagia, it can affect medicines taking behaviour and healthcare professionals are largely unaware of this1,2. Similar research has not been undertaken in the UK. Adherence related pharmacy based services in the UK provide an opportunity for community pharmacists to identify the problem and facilitate better medicines use. The aim of this pilot study was to estimate the level of patient reported dysphagia in older persons using community pharmacies in the UK, describe how it affects their medicine taking behaviour and identify whether advanced pharmacy services are related to improved awareness of this.

Cosmo, Cosmolino: Patent law and nanotechnology

Patent law has a significant instrumental and symbolic role in regulating nanotechnology. A 2011 report of the United States Federal Trade Commission noted that ‘the patent system plays a critical role in promoting innovation across industries from biotechnology to nanotechnology, and by entities from large corporations to independent inventors’. This chapter considers the much contested legal, ethical and social issues involved with regulating the patenting of nanotechnology. Section I considers the efforts of patent offices to classify nanotechnology and the empirical evidence about patent filing rates. Section II examines whether there is a ‘tragedy of the anticommons’ emerging in respect of nanotechnology. It contemplates access mechanisms – such as the defence of experimental use, patent pools, open innovation models and technology transfer. Section III explores ethical and social concerns associated with nanotechnology – in particular, issues about the impact upon human health and the environment.

Patent-busting: The public patent foundation, gene patents and the Seed Wars

This chapter considers the Public Patent Foundation as a novel institution in the patent framework. It contends that such a model can play a productive role in challenging the validity of high-profile patents; working as an amicus curiae in significant court cases; and also promoting patent law reform. However, there are limits to the ‘patent-busting’ of the Foundation. The not-for-profit legal services organization has only had the time and resources to challenge a number of noteworthy patents. Other jurisdictions – such as Australia – lack such public-spirited "patent-busting" entities. This chapter considers a number of key disputes involving the Public Patent Foundation. Part I examines the role of the Public Patent Foundation in the landmark dispute over Myriad Genetics’ patents in respect of breast cancer and ovarian cancer. Part II considers the role of the Public Patent Foundation in litigation between organic farmers and Monsanto. Part III examines the role of the Public Patent Foundation in larger debates about patent law reform in the United States – particularly looking at the Leahy-Smith America Invents Act 2011 (US). The conclusion contends that the patent-busting model of the Public Patent Foundation should be emulated in respect of other technological fields, and other jurisdictions – such as Australia. The initiative could also be productively applied to other forms of intellectual property – such as trade mark law, designs law, plant breeders’ rights, plant breeders’ rights, and access to genetic resources.

The high price of drug patents: Australia, patent law, pharmaceutical drugs and the Trans-Pacific Partnership

This week, the secrecy surrounding an independent Australian report on patent law and pharmaceutical drugs has been lifted, and the work has been published to great acclaim...

Patents for humanity

This article evaluates two policy initiatives by the United States Government to address access to essential medicines -- Priority Review vouchers and “Patents for Humanity." Such proposals are aimed at speeding up the regulatory review of inventions with humanitarian uses and applications by the United States Food and Drug Administration, and the United States Patent and Trademark Office. It is argued that such measures fall short of international standards and norms established by the World Intellectual Property Organization Development Agenda 2007; the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision of August 30, 2003; and the World Health Organization’s declarations on intellectual property and public health. This article concludes that there is a need for broader patent law reform in the United States to address matters of patent law and public health. Moreover, there is a need to experiment with other, more promising alternative models of research and development -- such as medical innovation prizes, a Health Impact Fund, the Medicines Patent Pool, and Open Source Drug Discovery.