Pharmaceuticals Policy and Law - Volume 19, issue 1-2
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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 trade in illegal pharmaceuticals is a global problem for public health. The transgressions of the rules that govern the distribution and marketing of medicinal products comes in many different forms, including substandard medicines, falsified drugs, counterfeits, ineffective medicines, falsely-labelled medicines and unregistered medicines. All of which breach different provisions of the pharmaceutical legislation and could be appropriately qualified as illegal. In order to prevent the presence in the market of illegal products is necessary a global approach to define the scope of the problem and the measures to be put in place. It corresponds to the administrative,…civil and criminal law to define the different problems and establish the corresponding penalties. Governments on their part should strengthen their controls to detect illegal medicines. The protection of intellectual property rights is interlinked with the protection from illegal medicines trade and a fundamental issue for the pharmaceutical sector and the patients. If we want better medicines, the patent system is the way to encourage it. An effective intellectual property system provide fair and efficient incentives for innovation. The challenge for governments is to improve the chain of responsibilities to protect the pharmaceuticals market. The improvement of the enforcement of the administrative, civil and penal regulations is imperative.
Keywords: Substandard medicines, falsified drugs, counterfeits, ineffective medicines, falsely-labelled, unregistered medicines, pharmaceutical law, patents, intellectual property rights, EU, Council of Europe, Medicrime Convention, pharmaceuticals inspection, drug distribution
Abstract: This paper analyzesthree recent cases of pharmaceutical corruption and develops a governance framework, using the fraud diamond theory , for the prevention of corruption. Pharmaceutical companies rely heavily on marketing strategies to gain the loyalty of prescribing doctors and patients . These aggressive marketing activities sometimes take an illegal twist by turning into corruption. In 2011, Johnson & Johnson agreed to pay US$70 million to settle Department of Justice charges related to foreign bribery. This paper shows that the following strategies are effective at preventing pharmaceutical corruption: Offering employee assistance programs and revising performance goals tied to sales or stock…prices; using transformational leadership; offering and certifying employee training on key company policies and anti-bribery legislations; using open-door policies and anonymous reporting mechanisms; assessing corruption risks associated with doing business in the world's poorest countries and contracting with third-party agents; implementing proper anti-corruption controls such as segregating the research funding function from the sales division; and detecting common corruption schemes, such as fictitious marketing agreements with off-shore entities and sham contracts with doctors, through the analysis of relevant red flags. This paper contributes to academia and the forensic accounting profession by discussing strategies and red flags analyses that should be implemented by pharmaceutical companies to prevent corruption. It extends previous research by tying together various strategies into a single framework for the prevention of pharmaceutical corruption. This framework will help deter pharmaceutical corruption and improve internal controls in this industry.
Abstract: From the beginning of the decade of 2000, the need to simplify the collection and transfer of ``health information'', along with the need to strictly control health prescriptions and medicinal products dispensed for SSN (Italian National Health System) users, marked the start of the computerisation of medical prescriptions and electronic circulation of drugs prescriptions. The purpose of this work is to reconstruct the domestic regulation according to the European principles, identifying the main strengths and weaknesses in order to improve the medical and pharmaceutical care for users and the streamlining of costs. Finally, the national electronic prescription and its connection…with electronic health registers will be analysed.
Keywords: Pharmaceutical care, electronic prescription, pharmaceutical costs, computerized medical prescriptions, electronic clinical history, national health service
Abstract: This paper defends that it is necessary to regulate the cross-border healthcare in the European Union, and, specifically, the recognition of medical prescriptions issued in other Member States. And this, obviously, without neglecting the Public Health protection, verifying the authenticity of the medical prescriptions, whether they were issued by a qualified professional legally entitled to do so or facilitating the correct identification of medicinal products or medical devices prescribed on them; avoiding any restriction to their recognition, unless their purpose is to protect the Public Health, based in legitimate and justified doubts on the authenticity, content or intelligibility of a…certain medical prescription or due to ethical reasons for the dispensing pharmacist.
Keywords: European Union, cross-border healthcare, medical prescription, recognition
Abstract: ``Drug regulation" is the internationally accepted term for the set of activities designed to provide the public with qualitative, efficient and safe medications. In Bulgaria, a number of laws and regulations are in place. The primary tool for providing the chronically ill with medications is the so called positive medication list. The aim of this study was to describe the positive and negative aspects of the acting drug regulation model. Materials and Methods: A form was constructed with information for conducting the focus groups and included a written informed consent. The selection of the participants was performed by providers and…users of medical care. The audio recordings were transcribed, and three step analyses were performed. Results: The focus group discussions included two main topics - the policies for medication reimbursement for the chronically ill and the expense of medications. As a whole, the system was determined to be extremely bureaucratic. One of the most important limitations of the current model is the lack of individualization for treating particular patients with a chronic disease. Conclusions: The general attitude of the participants was that there are multiple disadvantages of the current policy for providing medications to the chronically ill and that change is necessary.
Keywords: Drug policy, reimbursement, chronically ill, focus group
Abstract: BACKGROUND: Generic drugs are considered the best alternative for the high cost originator brand drugs as they have the same quality, safety, and efficacy at reduced cost. OBJECTIVES: The objective of this study is to encourage patients and health care providers to use generic medicines in Jordan by providing a pharmacoeconomic evidence for the expected savings of using generic medicines instead of originator medicines. Furthermore, this study insists on the importance of, and the need for, adaptation of Pharmacoeconomic analysis to the situation in Jordan, and explores how to promote greater prescribing of generic drugs for…patients with chronic diseases. METHODS: Thirty-seven Active ingredients from different therapeutic classes were included according to predefined inclusion/exclusion criteria; drugs used for chronic diseases were included whereas controlled drugs or sustained release or combination or parenteral drugs were excluded. The prices of originator drugs and all available generics were collected. As we are comparing brands with generics, cost minimisation analysis was used to show ``cost savings'' of one treatment over another that achieve the same level of benefit at reduced cost. Moreover, policy recommendations to encourage the use of generics were suggested. RESULTS: The average price saving from using average price generics available instead of originator drugs in Jordan was 32.68%, the maximum saving 74.29%, more saving could be achieved if we used the lowest available generics instead of average available generics price. CONCLUSIONS: This article insists on the importance of promoting the use of generics in Jordan by providing a pharmacoeconomic evidence and applicable simple policy recommendations, such as changing pharmacy remuneration, introduction of generic prescribing and allowing generic substitution, implementing of alternative product list with prices, activating electronic prescribing and providing education and awareness programs targeting health providers and publics.
Abstract: The medicinal product set of rules in the European Union includes a full regulation of the required conditions for its marketing that provide the highest levels of safety that should be expected from this kind of consumption products. However,^1 sometimes the failure by the manufacturer to comply with this requirements or the innovative nature of the product lead to cases of defective medicinal products in the market, which generates a civil liability of the manufacturer with the consumer. The legal framework of the medicinal product does not include a civil liability regime of its own, but rather it should be…applied the general regime of civil liability for defective products established in the EU Directive for the harmonisation of the national regulations regarding the liability for damages caused by defective consumption products in general, which defines a direct and objective liability of the manufacturer. In terms of civil liability, the Spanish legislation has incorporated the European criteria, but due to the characteristics of the medicinal product, those general European criteria need to be adapted to the singularities of the product and to be interpreted by the courts to which the liability is demanded. The court decisions from the Spanish courts of justice regarding defective medicinal products cases occurred in the last decade are gathered, analysed and systematized in this work. We distinguish between the jurisprudence based on the defect in manufacturing, the defect in the design and the defect in the information, which are the three different kinds of civil liability considered in the application of the European regulation regarding the concept of defective product. The interpretation that each court makes results in contradictory decisions, and hence, the determination of the liability is not made in a direct way, as the community regulation intends, which leads to conclude that it is necessary a more detailed regulation for the medicinal products sector.
Keywords: Defective medicinal products, civil liability, liability for defective products
Abstract: The ``vaccine hesitancy'' is an emerging risk that is demanding a response that emphasises the consensual participation and the transparency within the decision-making process from the public authorities. It would be convenient the creation of an Advisory Committee of Vaccines at national level with representatives of all interested parties, the regulation of the lobbies and groups of interest in Spain and a more strict control of the quality of public health information.
Keywords: Vaccine hesitancy, transparency, lobbies, public health information