Pharmaceuticals Policy and Law - Volume 14, issue 2-4
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The Health-Care fraudulent practices cost billions of dollars each year. Fraud and corruption activities can take place in any healthcare systems, whether they are predominantly public or private, well funded or poorly funded, and in any area of healthcare delivery. Rooting out health care fraud is central to the well-being of both the citizens and the overall economy. Fraud and corruption in the healthcare sector are often hard to detect unlawful behaviour. Healthcare is increasingly becoming…multinational and needs tackling as such. A major concern has been fraud schemes by pharmaceutical manufacturers and distributors. The world pharmaceutical market was worth an estimated € 614,583 million ($ 855,500 million) at ex-factory prices in 2011. The pharmaceutical industry's reputation has come under fire concerning the lack of transparency around its relationships with governments and the health community. The annalist and the news papers condemn the disconnect between the self-serving proclamations of "high ethical standards" and the reality of pharma's conduct. The regulation of the prosecution of the pharmaceutical fraud it is too completely different in United Stated, EU and other countries. It is very important for the sector react whit efficacy. Its it one challenge for the companies and for preserve the huge historical contribution in the health. Our society need to preserve this patrimony and increase his efficacy.Building trust and transparency are indispensable in the new policy on corporate social responsibility in the pharmaceutical industry.
Keywords: Pharmaceutical fraud, Medicaid, Medicare, False Claims Act, Off Label Marketing, corporate responsibility, EU
Abstract: Borderline medical products have continued to pose as a challenge to regulators of cosmetics, medical devices and pharmaceutical products in Europe. Borderline products refer to products that exhibit multiple product characteristics and therefore could potentially straddle a minimum of two product regulatory categories. Legislation solutions in the form of the `rule of doubt' provisions function on the principle of adoption of a higher burden in case of confusion exist. Although they do provide immediate solutions, they…fail in ensuring legal certainty to all the principal stakeholders. This article discusses the jurisprudence on borderline products based on national and European case law. While this jurisprudence clarifies several regulatory points of conflict, it is in many ways limited. Questions of regulatory categorization are essentially science questions – that are evolving – and are therefore bound to escape determinative categories propounded within European regulations. The solution lies in appreciating the role played by deliberative institutional networks that are active contributors of regulatory disciplines and ensuring mechanisms by which judges will be able to access scientific knowledge on this issue.
Keywords: Regulation, Europe, pharmaceutical, medical devices, cosmetics, case law, borderline products
Abstract: Objective: "Zero mark-up policy" was introduced in Beijing community health centers (CHCs) with three government subsidy approaches: fixed subsidy (FS), income-linked subsidy (IS) with income and expenditure controlled by government, and self-financing with mark-up compensation from government purchasing services (GPS). This study analyzes the cost containment effect and its effect on the operation of CHCs and staff moral. Methods: CHCs are randomly sampled and distributed in 3 government subsidy approach groups. The…effect is measured with changes of medicine use and cost, income of facilities and staff before and after the policy in each group, and compared among groups. Results: Cost proportion of zero mark-up medicines per visit in FS/IS/GPS is 75.4%/57.8%/52.6% by 2009. Medicines cost per visit in FS and IS reduces 18.7% and 1.9% by 2007 (P=0.001, α=0.05, t test), and rebounds in 2008–9; GPS increases 25.2% by 2007 and keeps growing. Between 2006 and 2009, government subsidy is always the highest in FS and lowest in GPS. The annual salary of FS is always the highest and increases the fastest. Conclusions: The "zero mark-up policy" contains medicines costs. FS is more effective than IS and GPS. GPS causes lower willingness to use zero mark-up medicines. FS and IS need to improve the work enthusiasm. IS has mixed effect.
Keywords: Mark-up, government subsidy, community health facility
Abstract: Objective: To carry out a systematic literature review to identify elements that either hinder or facilitate the entry of medicines in European countries characterized by small populations or low income levels. Methodology: We searched MedLine, Web pages, OECD Publications and PPRI reports, using key words and free terminology. We included studies concerning the availability of medicines in European countries with Small Market. Two independent reviewers carried out the review process. Results: The size of pharmaceutical markets…appears as one of the obstacles to introducing new medicines in countries, rather than low purchasing power or lack of competition in certain therapeutic sectors. Requirements involving the translation and labelling of products can pose problems for small pharmaceutical companies. The literature also shows that patients with rare diseases sometimes suffer from the lack of an adequate supply of drugs. Conclusion: There is a paucity of published evidence on the impact of availability of drugs in the small market. This review highlights the need for more studies to build an evidence base on the availability of medicines in countries with low incomes or small population.
Abstract: Major progress has been achieved over the last years in EU. Legislative initiatives have led to improved marketing authorisation procedures, the harmonisation of data protection in the EU, better access to medicines for children, and a new regulatory framework for advanced therapies. Nevertheless stakeholders continue to raise concerns with regard to the market fragmentation linked to disparities in national pricing and reimbursement schemes, unnecessary regulatory burdens caused by divergences in the implementation…of Community legislation, and divergence in interpreting the relevant legislation and cumbersome procedures for multi-centre clinical trails in different Member States. New legislation are preparing. Establishing and enforcing international public health standards is essential to minimise the risk that unsafe products enter the EU market.
Keywords: Pricing, active substances, clinical trails, unique identifier, global cooperation, harmonisation
Abstract: The use of medicines out of the technical specifications or off-label use is legal and a common medical practice all around the world. However, there is a lack of unanimity of criteria and specific regulations about this special situation in a lot of countries. This lack of clear regulation of this particular situation, with strong ethical implications, may involve greater risks to the population and worse health outcomes. The aim of this article is to present a theoretical framework about the…problem of off-label use of drugs with particular emphasis on the situation Argentina and the example of the use of Bevacizumab in the treatment of Neovascular Age-Related Macular Degeneration. The role of pharmacist may be crucial ensuring the correct use of medicines, and his intervention generate benefits for both the patient and the institutions in an interdisciplinary approach to pharmacotherapy.
Abstract: Studies of residues depletion among food-producing animals represent a fundamental aspect regarding the security section of the registration-dossier of veterinary medicines. The withdrawal period of the aforementioned studies ensures that food products from animals treated with veterinary medicines do not contain toxic residue which exceeds the maximum limits, which are established by the health authority for the pharmacologically active substance, and therefore it protects public health. The aim of this study is to revise the…existing legislation in Spain and in the European Union with the purpose of optimizing the professional pharmaceutical knowledge. The aforesaid health personnel will be portrait as medicine specialist at a community level and therefore the personnel has the knowledge necessary for its integration into multidisciplinary teams which develop the design, interpretation and monitoring of the studies of residues depletion, according to the legislation currently in force.
Keywords: Withdrawal period, pharmaceutical legislation, public health, marketing authorisation, guarantee of safety