Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Looking twice at the gender equity index for public health impact

Background: It has been shown that gender equity has a positive impact on the everyday activities of people (decision making, income allocation, application and observance of norms/rules) which affect their health. Gender equity is also a crucial determinant of health inequalities at national level; thus, monitoring is important for surveillance of women’s and men’s health as well as for future health policy initiatives. The Gender Equity Index (GEI) was designed to show inequity solely towards women. Given that the value under scrutiny is equity, in this paper a modified version of the GEI is proposed, the MGEI, which highlights the inequities affecting both sexes. Methods: Rather than calculating gender gaps by means of a quotient of proportions, gaps in the MGEI are expressed in absolute terms (differences in proportions). The Spearman’s rank coefficient, calculated from country rankings obtained according to both indexes, was used to evaluate the level of concordance between both classifications. To compare the degree of sensitivity and obtain the inequity by the two methods, the variation coefficient of the GEI and MGEI values was calculated. Results: Country rankings according to GEI and MGEI values showed a high correlation (rank coef. = 0.95). The MGEI presented greater dispersion (43.8%) than the GEI (19.27%). Inequity towards men was identified in the education gap (rank coef. = 0.36) when using the MGEI. According to this method, many countries shared the same absolute value for education but with opposite signs, for example Azerbaijan (−0.022) and Belgium (0.022), reflecting inequity towards women and men, respectively. This also occurred in the empowerment gap with the technical and professional job component (Brunei:-0.120 vs. Australia, Canada Iceland and the U.S.A.: 0.120). Conclusion: The MGEI identifies and highlights the different areas of inequities between gender groups. It thus overcomes the shortcomings of the GEI related to the aim for which this latter was created, namely measuring gender equity, and is therefore of great use to policy makers who wish to understand and monitor the results of specific equity policies and to determine the length of time for which these policies should be maintained in order to correct long-standing structural discrimination against women.

From problems to opportunities a shift needed for public health

Public health has in the past been a problem orientated discipline which has devoted its energies mainly to defining, prioritizing and trying to solve problems. This means paying attention to the short-term. If we examine the rises and falls of public health as a discipline with its successes and failures in gaining health, and if we compare public health with successful organisations, the need for changing the emphasis from problems to opportunities becomes apparent. In this endeavour for the future, strategic thinking and policy analysis seem appropriate new tools for public health professionals. The economic crisis and the weakness of the welfare state are presented as major opportunities for public health to achieve health gain in Europe.

Regional health governance: a comparative perspective on EU and ASEAN. EU Centre in Singapore Policy Brief No. 4, June 2012

Globalisation has led to new health challenges for the 21st Century. These challenges have transnational implications and involve a large range of actors and stakeholders. National governments no longer hold the sole responsibility for the health of their people. These changes in health trends have led to the rise of Global Health Governance as a theoretical notion for health policy-making. The Southeast Asian region is particularly prone to public health threats and it is for this reason that this brief looks at the potential of the Association of Southeast Asian Nations (ASEAN) as a regional organisation to take a lead in health cooperation. Through a comparative study between the regional mechanisms for health cooperation of the European Union (EU) and ASEAN, we look at how ASEAN could maximise its potential as a global health actor. Regional institutions and a network of civil society organisations are crucial in relaying global initiatives for health, and ensuring their effective implementation at the national level. While the EU benefits from higher degrees of integration and involvement in the sector of health policy making, ASEAN’s role as a regional body for health governance will depend both on greater horizontal and vertical regional integration through enhanced regional mechanisms and a wider matrix of cooperation.

Value of health - too often ignored and forgotten by EU policy-makers? EPC Commentary, 29 September 2014

Whether on national or European level, policy-makers tend to under-value health, healthy society, and healthy citizens in policy-making. As the European Commission continue to ponder how questions related to health should be reflected in EU policy-making and what role it should take, there are three issues to keep in mind: 1) there is a need to recognise health as a value, 2) health should be considered across policies, 3) the EU has the tools to promote a healthier European society.

Keeping health high on the EU agenda: role for economic governance? EPC Policy Brief, 7 May 2015

In an attempt to get Europe out of the economic crisis and establish right conditions for growth, the EU coordinates and monitors member states’ economic and budgetary policies via a system called the European Semester. As member states’ spending on the health sector accounts for 10% of GDP and is expected to grow, it is no wonder that an increasing emphasis has been paid to sustainability of health systems – an area that is traditionally considered as a national competence. In this Policy Brief, Annika Hedberg and Martina Morosi reflect on the strengths and weaknesses of the European Semester and country-specific recommendations in promoting more sustainable and efficient health systems in Europe, and why the EU must continue to play a role in encouraging member states to value health and improve their spending on health.

Towards better health outcomes - What role for pharmaceutical innovation? EPC Policy Brief, 10 December 2015

From the current refugee crisis to ageing populations, and from rising healthcare prices to patients’ rising expectations: demands on European health systems continue to increase. Delivering health efficiently and ensuring the long-term sustainability of healthcare in the face of reduced public budgets requires new thinking – and there is a role for pharmaceuticals as well. Building on the series of discussions organised under Transformations, this Policy Brief focuses on the specific role of medicines and pharmaceutical innovation in improving health outcomes. It considers the state of play of drug innovation, from the development to the deployment of medicines, and the measures needed to make it deliver more for society and the economy, while ensuring that patients in Europe can have access to innovative and safe solutions.

Healthy people 2000 : public health service action /

Mode of access: Internet.

The Public Health Service strategic plan to combat HIV & AIDS in the United States /

Running title: Strategic plan to combat AIDS & HIV in the U.S.

Challenge and opportunity: public health in an era of change.

"March 1996."

Home health agencies in Illinois, 1987 : a cooperative study of Illinois Department of Public Health and Illinois Council on Home Health Services.

Mode of access: Internet.

Health policy update /

Title from caption.

Illinois plan for public health systems change.

A report by Public Health Futures Illinois that proposes goals and recommended actions for developing a prevention-focused, integrated system of public health service delivery in Illinois.

Proceedings of the Illinois Oral Health Summit and the Illinois Oral Health Plan : Illinois' response to the U.S. Surgeon General's report : Oral Health in America, convened by the Illinois Dept. of Public Health and held at the University of Illinois at Chicago's School of Public Health, Chicago Illinois on September 11, 2001.

Introduction: The major findings and suggested framework for action put forth by the U.S. Surgeon General form the basis for Illinois' plan. Augmenting this foundation is the collective wisdom of citizens, stakeholders and policy makers. The result is a comprehensive vision that can be embraced by all involved in the process. The plan articulates goals, priorities and strategies to improve the oral health of all Illinoisans. Its five policy goals reflect specific priorities and its recommended strategies and action steps suggest how to address each of them. The plan concludes with a call for the establishment of a select committee to monitor and provide guidance in the implementation of the plan.

The Public health index : measuring the health of Illinois residents.

"January, 1988."