The race to patent the SARS virus: The TRIPS agreement and access to essential medicines

This article considers the race to sequence the Severe Acute Respiratory Syndrome virus ('the SARS virus') in light of the debate over patent law and access to essential medicines. Part II evaluates the claims of public research institutions in Canada, the United States, and Hong Kong, and commercial companies, to patent rights in respect of the SARS virus. It highlights the dilemma of ’defensive patenting' - the tension between securing private patent rights and facilitating public disclosure of information and research. Part III considers the race to patent the SARS virus in light of wider policy debates over gene patents. It examines the application of such patent criteria as novelty, inventive step, utility, and secret use. It contends that there is a need to reform the patent system to accommodate the global nature of scientific inquiry, the unique nature of genetics, and the pace of technological change. Part IV examines the role played by the World Trade Organization and the World Health Organization in dealing with patent law and access to essential medicines. The article contends that there is a need to ensure that the patent system is sufficiently flexible and adaptable to accommodate international research efforts on infectious diseases.

Changing travel patterns and journeys to health services in Great Britain 1985-2012: An examination health service utilisation using the National Travel Survey

Background This paper examines changing patterns in the utilisation and geographic access to health services in Great Britain using National Travel Survey data (1985-2012). The National Travel Survey (NTS) is a series of household surveys designed to provide data on personal travel and monitor changes in travel behaviour over time. The utilisation rate was derived using the proportion of journeys made to access health services. Geographic access was analysed by separating the concept into its accessibility and mobility dimensions. Methods Variables from the PSU, households, and individuals datasets were used as explanatory variables. Whereas, variables extracted from the journeys dataset were used as dependent variables to identify patterns of utilisation i.e. the proportion of journeys made by different groups to access health facilities in a particular journey distance or time band or by mode of transport; and geographic access to health services. A binary logistic regression analysis was conducted to identify the utilisation rate over the different time periods between different groups. This analysis shows the Odds Ratios (ORs) for different groups making a trip to utilise health services compared to their respective counterparts. Linear multiple regression analyses were conducted to then identify patterns of change in the accessibility and mobility level. Results Analysis of the data has shown that that journey distances to health facilities were signi fi cantly shorter and also gradually reduced over the period in question for Londoners, females, those without a car or on low incomes, and older people. Although rates of utilisation of health services we re Oral Abstracts / Journal of Transport & Health 2 (2015) S5 – S63 S43 signi fi cantly lower because of longer journey times. These fi ndings indicate that the rate of utilisation of health services largely depends on mobility level although previous research studies have traditionally overlooked the mobility dimension. Conclusions This fi nding, therefore, suggests the need to improve geographic access to services together with an enhanced mobility option for disadvantaged groups in order for them to have improved levels of access to health facilities. This research has also found that the volume of car trips to health services also increased steadily over the period 1985-2012 while all other modes accounted for a smaller number of trips. However, it is dif fi cult to conclude from this research whether this increase in the volume of car trips was due to a lack of alternative transport or due to an increase in the level of car-ownership.

Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

Open Access to Scientific Publications – An Analysis of the Barriers to Change?

One of the effects of the Internet is that the dissemination of scientific publications in a few years has migrated to electronic formats. The basic business practices between libraries and publishers for selling and buying the content, however, have not changed much. In protest against the high subscription prices of mainstream publishers, scientists have started Open Access (OA) journals and e-print repositories, which distribute scientific information freely. Despite widespread agreement among academics that OA would be the optimal distribution mode for publicly financed research results, such channels still constitute only a marginal phenomenon in the global scholarly communication system. This paper discusses, in view of the experiences of the last ten years, the many barriers hindering a rapid proliferation of Open Access. The discussion is structured according to the main OA channels; peer-reviewed journals for primary publishing, subject- specific and institutional repositories for secondary parallel publishing. It also discusses the types of barriers, which can be classified as consisting of the legal framework, the information technology infrastructure, business models, indexing services and standards, the academic reward system, marketing, and critical mass.

Chinese immigrants to Finland: A qualitative study of housing, employment, access to health care and child care as sociological dimensions in their settlement process

The Master’s thesis is qualitative research based on interviews of 15 Chinese immigrants to Finland in order to provide a sociological perspective of the migration experience through the eyes of Chinese immigrants in the Finnish social welfare context. This research is mainly focused upon four crucial aspects of life in the settlement process: housing, employment, access to health care and child care. Inspired by Allardt’s theoretical framework ‘Having, Loving and Being’, social relationships and individual satisfaction are examined in the case of Chinese interviewees dealing with the four life aspects. Finland was not perceived as an attractive migration destination for most Chinese interviewees in the beginning. However, with longer residence in Finland, the Finnish social welfare system gradually became a crucial appealing factor in their permanent settlement in Finland. And meanwhile, social responsibility of attending their old parents in China, strong feelings of being isolated in Finland, and insufficient integration into the Finnish society were influential factors for their decision of returning to China. Social relationships with personal friends, migration brokers, schools, employers and family relatives had great influences in the four life aspects of Chinese immigrants in Finland. The social relationship with the Finnish social welfare sector is supportive to Chinese immigrants, but Chinese immigrants do not heavily rely on Finnish social protection. The housing conditions were greatly improved over time while the upward mobility in the Finnish labour market was not significant among Chinese immigrants. All Chinese immigrants were satisfied with their current housing by the time I interviewed them while most of them had subjective feelings of being alienated in the Finnish labour market, which seriously prevented them from integrating into the Finnish society. In general, Chinese immigrants were satisfied with the low cost of accessing the Finnish public health care services and affordable Finnish child day care services and financial subsidies for children from the Finnish social welfare sector. This research also suggests that employment is the central basis in well-being. Support from the Finnish social welfare sector can improve the satisfaction levels among immigrants, especially when it mitigates the effects of low-paid employment. As well, my empirical study of Chinese immigrants in Finland shows that Having (needs for materials), Loving (needs for social relations) and Being (needs for social integration) are all involved in the four concrete aspects (housing, employment, access to health care and child care).

Does improved access to diagnostic imaging results reduce hospital length of stay? A retrospective study.

BACKGROUND: One year after the introduction of Information and Communication Technology (ICT) to support diagnostic imaging at our hospital, clinicians had faster and better access to radiology reports and images; direct access to Computed Tomography (CT) reports in the Electronic Medical Record (EMR) was particularly popular. The objective of this study was to determine whether improvements in radiology reporting and clinical access to diagnostic imaging information one year after the ICT introduction were associated with a reduction in the length of patients' hospital stays (LOS). METHODS: Data describing hospital stays and diagnostic imaging were collected retrospectively from the EMR during periods of equal duration before and one year after the introduction of ICT. The post-ICT period was chosen because of the documented improvement in clinical access to radiology results during that period. The data set was randomly split into an exploratory part used to establish the hypotheses, and a confirmatory part. The data was used to compare the pre-ICT and post-ICT status, but also to compare differences between groups. RESULTS: There was no general reduction in LOS one year after ICT introduction. However, there was a 25% reduction for one group - patients with CT scans. This group was heterogeneous, covering 445 different primary discharge diagnoses. Analyses of subgroups were performed to reduce the impact of this divergence. CONCLUSION: Our results did not indicate that improved access to radiology results reduced the patients' LOS. There was, however, a significant reduction in LOS for patients undergoing CT scans. Given the clinicians' interest in CT reports and the results of the subgroup analyses, it is likely that improved access to CT reports contributed to this reduction.

Perceived and reported access to the general practitioner: an international comparison of universal access and mixed private/public systems.

Timely and convenient access to primary healthcare is essential for the health of the population as delays can incur additional health and financial costs. Access to health care is under increasing scrutiny as part of the drive to contain escalating costs, while attempting to maintain equity in service provision. The objective was to compare primary care services in Republic of Ireland and Northern Ireland, and to report on perceived and reported access to GP services in universal access and mixed private/public systems. A questionnaire study was performed in Northern Ireland (NI) and the Republic of Ireland (ROI). Patients of 20 practices in the ROI and NI were contacted (n = 22,796). Main outcome measures were overall satisfaction and the access to GP services. Individual responses and scale scores were derived using the General Practice Assessment Questionnaire (G-PAQ). The response rate was 52% (n = 11,870). Overall satisfaction with GP practices was higher in ROI than in NI (84.2% and 80.9% respectively). Access scores were higher in ROI than in NI (69.2% and 57.0% respectively) Less than 1 in 10 patients in ROI waited two or more working days to see a doctor of choice (8.1%) compared to almost half (45.0%) in NI. In NI overall satisfaction decreased as practice size increased; 82.8%, 80.4%, and 75.8%. In both systems, in large practices, accessibility is reduced when compared to smaller practices. The faster access to GP services in ROI may be due to the deterrent effect of the consultation charge freeing up services although, as it is the poorest and sickest who are deterred by the charge this improved accessibility may come at a significant cost in terms of equity. The underlying concern for policy makers centres around provision of equitable services.

Breast cancer mortality in neighbouring European countries with different level of breast screening but similar access to treatment: An analysis of WHO mortality database

Objective: To compare trends in breast cancer mortality within three pairs of neighbouring European countries in relation to implementation of screening. Design: Retrospective trend analysis.
Setting: Three country pairs (Northern Ireland (United Kingdom) v Republic of Ireland, the Netherlands v Belgium and Flanders (Belgian region south of the Netherlands), and Sweden v Norway).
Data sources: WHO mortality database on cause of death and data sources on mammography screening, cancer treatment, and risk factors for breast cancer mortality.
Main outcome measures: Changes in breast cancer mortality calculated from linear regressions of log transformed, age adjusted death rates. Joinpoint analysis was used to identify the year when trends in mortality for all ages began to change.
Results: From 1989 to 2006, deaths from breast cancer decreased by 29% in Northern Ireland and by 26% in the Republic of Ireland; by 25% in the Netherlands and by 20% in Belgium and 25% in Flanders; and by 16% in Sweden and by 24% in Norway. The time trend and year of downward inflexion were similar between Northern Ireland and the Republic of Ireland and between the Netherlands and Flanders. In Sweden, mortality rates have steadily decreased since 1972, with no downward inflexion until 2006. Countries of each pair had similar healthcare services and prevalence of risk factors for breast cancer mortality but differing implementation of mammography screening, with a gap of about 10-15 years.
Conclusions: The contrast between the time differences in implementation of mammography screening and the similarity in reductions in mortality between the country pairs suggest that screening did not play a direct part in the reductions in breast cancer mortality.

“I used to think that they were all abnormal. And I was the normal one”: conceptualizing mental health and mental health treatment under Improving Access to Psychological Therapies (IAPT)

Background: Improving Access to Psychological Therapies (IAPT) was introduced in the United Kingdom in 2006 to provide more effective and efficient services to people experiencing mild to moderate mental ill health. The model represents a paradigm shift in how we provide psychological care to large populations. Aims: We wanted to document how the IAPT programme impacted on patients’ understanding of their mental health, and mental health treatment. Methods: We used Foucauldian Discourse Analysis to analyse six semi-structured research interviews with patients from one IAPT service in a major UK city. Results: Participants constructed their mental health problems as individual pathologies. Constructions of mental health and of treatment evidenced the privileging of personal responsibility and social productivity over dependency on others and the state. Conclusions: Services are functioning well for some. The role of IAPT in pathologising those who are dependent on people and services requires further commentary and action. Declaration of interest: The first author was employed by the same organisation that delivered the IAPT service, although through a separate staffing and management line.

Exploring and Improving Access to Direct Payments by People with Dementia Living in Rural Communities

Direct payments are cash payments made to individuals eligible for social care services which allow them to manage and pay for their own social care rather than receiving it directly from their Local Authority. Research suggests that direct payments can enable people with dementia to stay in their own home for longer, and experience greater choice, flexibility and an improved social life. However, uptake of direct payments is currently low. People living in rural communities may particularly benefit from the additional flexibility offered by direct payments; however they may face difficulties accessing appropriate services. The aim of Phase 1 of the research is to explore the reasons why people with dementia who live in rural communities do or do not gain access to direct payments. This will be achieved through analysis of direct payment uptake data, focus groups with social workers, examination of online discussions about direct payments, and interviews with people with dementia, carers and social workers. Findings will inform Phase 2 of the research: the building and pilot testing of an intervention which can be utilised in rural communities to maximise access to direct payments by people with dementia.

Exploring and Improving Access to Direct Payments by People with Dementia Living in Rural Communities

Direct payments are cash payments made to individuals eligible for social care services which allow them to manage their own social care. Research suggests that direct payments can enable people with dementia to stay in their own home for longer and experience greater choice, flexibility and an improved social life. However uptake of direct payments is currently low. The first objective of this research was to explore the experiences of people with dementia living in rural communities, in relation to their access to direct payments. 26 semi-structured interviews were conducted with people with dementia in receipt of social care services in the community, and their carers and social workers. Focus groups were carried out with two community social work teams. Direct payments appeared to afford particular benefits to people with dementia and to those living in rural communities in terms of flexibility, continuity of care and access to local facilities. However it was found that many service users were daunted by the thought of managing their own social care budget. The second objective of the research was to design and pilot test an intervention aimed at increasing uptake of direct payments by people with dementia. This comprised a session delivered to a team of social workers, aimed at encouraging them to offer combined direct payments to service users as a potentially less daunting alternative to full direct payments. Combined direct payments enable service users to receive part of their social care budget as a direct payment while the remainder is retained and managed by the Local Authority. In order to evaluate the intervention direct payment uptake will be examined for the six-month period before and after the intervention session, and social workers in the intervention team will be interviewed about their experiences of offering combined direct payments to service users.

Exploring Access to Direct Payments by People with Dementia Living in Rural Communities

Direct payments are cash payments made to individuals eligible for social care services which allow them to manage their own social care. Research suggests that direct payments can enable people with dementia to stay in their own home for longer and experience greater choice, flexibility and an improved social life. However uptake of direct payments is currently low. There is a lack of research to date in this area which addresses the factors of dementia, ageing and rurality in unison. Therefore the objective of this research was to explore the experiences of people with dementia living in rural communities, in relation to their access to direct payments. 26 semi-structured interviews were conducted with people with dementia in receipt of social care services in the community, and their carers and social workers. Focus groups were carried out with two community social work teams, and existing online discussions regarding direct payments were examined. It was found that direct payments tended to be seen as a fall back option, for example as the only alternative to residential care, or as a potential solution to problems experienced by existing social care service users. Direct payments appeared to afford particular benefits to people with dementia and to those living in rural communities in terms of flexibility, continuity of care and access to local facilities. It is therefore important that this group are enabled to access direct payments; ensuring direct payments are viewed as a positive option by all stakeholders is key to this.

Exploring Access to Direct Payments by People with Dementia Living in Rural Communities

Direct payments are cash payments made to individuals eligible for social care services which allow them to manage their own social care. Research suggests that direct payments can enable people with dementia to stay in their own home for longer and experience greater choice, flexibility and an improved social life. However uptake of direct payments is currently low. There is a lack of research to date in this area which addresses the factors of dementia, ageing and rurality in unison. Therefore the objective of this research was to explore the experiences of people with dementia living in rural communities, in relation to their access to direct payments. 26 semi-structured interviews were conducted with people with dementia in receipt of social care services in the community, and their carers and social workers. Focus groups were carried out with two community social work teams, and existing online discussions regarding direct payments were examined. It was found that direct payments tended to be seen as a fall back option, for example as the only alternative to residential care, or as a potential solution to problems experienced by existing social care service users. Direct payments appeared to afford particular benefits to people with dementia and to those living in rural communities in terms of flexibility, continuity of care and access to local facilities. It is therefore important that this group are enabled to access direct payments; ensuring direct payments are viewed as a positive option by all stakeholders is key to this.

Exploring Access to Direct Payments by People with Dementia Living in Rural Communities

Direct payments are cash payments made to individuals eligible for social care services which allow them to manage and pay for their own social care rather than receiving it directly from their Local Authority. Research suggests that direct payments can enable people with dementia to stay in their own home for longer and experience greater choice, flexibility and an improved social life. However uptake of direct payments is currently low, particularly amongst people with dementia. Those living in rural communities may experience additional barriers to direct payments, such as transport issues and difficulty recruiting carers. There is a lack of research to date in this area which addresses the factors of dementia, ageing and rurality in unison. Therefore the objective of this research was to explore the experiences of people with dementia living in rural communities, in relation to their access to and use of direct payments. 26 semi-structured interviews were conducted with people with dementia in receipt of social care services in the community, and their carers and social workers. Focus groups were carried out with two community social work teams, and existing online discussions about direct payments contributed to by social care staff, people with dementia and their carers were examined. It was found that direct payments tended to be seen as a fall back option, for example as the only alternative to residential care, or as a potential solution to problems experienced by existing social care service users. Direct payments appeared to afford particular benefits to people with dementia and to those living in rural communities in terms of flexibility, continuity of care and access to local facilities. It is therefore important that this group are enabled to access direct payments; ensuring direct payments are viewed as a positive option by all stakeholders is key to this.

PREGNANCY-RELATED CHURN AND ACCESS TO CARE IN THE CONTEXT OF NARROW NETWORKS IN WASHINGTON STATE

Thesis (Master's)--University of Washington, 2016-03