Trade policy and health: from conflicting interests to policy coherence.
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Policy incoherence at the interface between trade policy and health can take many forms, such as international trade commitments that strengthen protection of pharmaceutical patents, or promotion of health tourism that exacerbates the shortage of physicians in rural areas. Focusing on the national policy-making process, we make recommendations regarding five conditions that are necessary, but not sufficient, to ensure that international trade policies are coherent with national health objectives. These conditions are: space for dialogue and joint fact-finding; leadership by ministries of health; institutional mechanisms for coordination; meaningful engagement with stakeholders; and a strong evidence base. (+info)
Opening up the Ivory Tower.
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Big pharma is increasingly looking to academia for new drug leads and technologies; meanwhile universities are being forced to look beyond the National Institutes of Health (NIH) for funding. This mutual attraction-out-of-necessity is helping to forge new bonds between industry and academia. (+info)
Biosimilars: opportunity or cause for concern?
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Biopharmaceuticals are drug products containing biotechnology-derived proteins as active substances, and have revolutionised the treatment of many diseases. A number of biopharmaceutical patents are due to expire in the next few years, or have already expired. The subsequent production of follow-on products, or 'biosimilars' has aroused interest within the pharmaceutical industry as biosimilar manufacturers strive to obtain part of an already large and rapidly-growing market. The potential opportunity for price reductions versus the originator biopharmaceuticals remains to be determined, as the advantage of a slightly cheaper price may be outweighed by the hypothetical increased risk of side-effects from biosimilar molecules that are not exact copies of their originators. This review focuses on the issues surrounding biosimilars, including manufacturing, quality control, clinical efficacy and side effects, and how government and industry regulations are evolving to deal with these topics. (+info)
Commentary: is totipotency of a human cell a sufficient reason to exclude its patentability under the European law?
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This article argues that totipotent character of human totipotent cells--defined as the capacity of a cell "to differentiate into all somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extra-embryonic tissues such as the placenta"--is not a sufficient reason to exclude their patentability on the basis of Article 5(1) of the Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (Biopatent Directive), which maintains that "the human body, at the various stages of its formation and development, [...] cannot constitute patentable inventions." Since human totipotent cells have both the potential to generate an entire new organism or to generate only different tissues or organs of an organism, they simultaneously fit the definition of the unpatentable human body at the earliest stage of its formation as well as of an element of the human body, which "may constitute a patentable invention" pursuant to Article 5(2) of the Biopatent Directive, whether that element is isolated from the human body or otherwise produced by means of a technical process. Therefore, this article suggests that, when evaluating patentability of human totipotent cells, they should be further evaluated according to their location and their method of derivation (i.e., whether human totipotent cells are located in the human body, whether they are isolated from the human body, or whether they are produced otherwise by means of a technical process). Disclosure of potential conflicts of interest is found at the end of this article. (+info)
From exotic spice to modern drug?
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The global demand for more affordable therapeutics and concerns about side effects of commonly used drugs are refocusing interest on Eastern traditional medicines, particularly those of India and China. (+info)
The fuzzy math of solid tumor stem cells: a perspective.
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Apparently effective therapeutic agents very often fail to cure cancer patients. It is therefore attractive to wonder whether a specific resistant cell subset should be recognized and separately targeted. In solid tumors, such as carcinomas, a minor population of "cancer stem cells" has been proposed and sought experimentally in human tumors and isolated cell populations. It is often overlooked that the rationale and supportive data are essentially numerical and can be evaluated as such. A reevaluation of the published studies and related claims within awarded U.S. patents suggests that the mathematical support for the concept of therapeutically useful stem cells is weak and may even invalidate the foundations of these publications and patent claims. Mathematical arguments should be used more consistently, because they can serve as a guide for interpreting studies into cancer stem cells of solid tumors. (+info)
Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system.
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Though patents are effective tools for promoting innovation and protecting intellectual property in the pharmaceutical sciences, there has been growing concern about 2 important ways that patents in this field can have a negative effect on patient care and the practice of medicine. First, inventors can seek and receive patents on pharmaceutical products or research tools that stretch the statutory requirements for patenting. Second, patent holders in the pharmaceutical market can use legal loopholes or aspects of the patent registration system to extend exclusivity for inventions beyond what was anticipated by the Patent Act or subsequent legislation. The monopoly control bestowed by such inappropriate patents or manipulation of the patent system can limit options available to patients, increase the cost of health care delivery, and make cooperative research more difficult. In response, several different government and market-based efforts have emerged to promote more equitable patent policy in health care that encourages dissemination of ideas while still supporting the development of innovative products. (+info)
The influence of market exclusivity on drug availability and medical innovations.
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The interpretation and application of intellectual property laws is enormously complex in the pharmaceutical industry, with companies needing to obtain multiple patents to fully protect their innovations. While patents provide important incentives for biomedical innovation and economic growth, concern has been expressed over the growing number of patents, the granting of patents on basic research tools (eg, genetically engineered animals), and the possibility that these legal protections may ultimately inhibit scientific advancement. (+info)