Pharmaceuticals Policy and Law - Volume 5, issue 0
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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: Developing countries face many problems in trying to ensure the accessibility of their populations to pharmaceuticals. The pharmaceutical market has traditionally been a global market. International organisations are trying to help developing countries in addressing the manifold problems posed by the need to make drugs accessible to developing countries' populations. In the following paragraphs the main problems and the most recent developments affecting that issue are reviewed and discussed.
Abstract: This paper focuses on the developments within the Finnish pharmaceutical industry during the past five years and the future prospects. We study the change in industry structure and the emergence of a Finnish Pharmacluster. The study of the Finnish pharmaceutical industry reflects the developments and changes in the technology base and business strategies in the international pharmaceutical industry. The paper suggests that the emergence of virtual operation modes is the result of the structural change process,…driven by a technological paradigm shift, taken place within pharmaceuticals for the past two decades. Evidence is provided based on a one-year research project on the Finnish pharmaceutical industry.
Abstract: This paper analyses the M&A and post-merger integration activities in the biotechnological and pharmaceutical industry resulting from a transformation process in both industries. To start with, the development of the pharmaceutical and biotechnology industry is analyzed from a more theoretical, literature-based point of view which leads to the conclusion that a strategic consolidation resulting in fewer but stronger, larger and more market capitalized companies is only a question of time. After that the M&A…activities in both industries are described in numbers in a more specific, empirical way in order to support the first conclusion. This analysis is subdivided in three different layers: pharma-to-pharma, pharma-to-biotech and biotech-to-biotech deals and clearly shows a significant increase in M&A activities in each of these layers. In a next step-two of these layers are looked at more closely, changing the analytical focus from the industry perspective to the company perspective. In the final section, there is the confrontation of the theoretical and empirical considerations and findings. This reveals that the pressure from capital markets in terms of the need for a blockbuster as well as in market capitalization, the acquisition of knowledge and the building-up of a critical mass as far as capacities are concerned are the key divers for M&A activities. According to the specific situation different post-merger integration strategies (absorption, symbiotic or preservation approach) apply. The central factors that foster a successful post-merger integration -- irrespective of what post-merger integration strategy is chosen -- are the existence of a powerful integration manager, extensive personal communication and a cultural fit.
Abstract: Currently the pharmaceutical industry is undergoing dramatic strategic changes, affecting the entire life science sector. In this paper the strategic change of the pharmaceutical industry is studied through the convergence of the food and pharmaceutical industry from the point of functional food. Our primary focus is on the European market. Starting from the life-sciences concept, several questions will be discussed: What are functional foods? Does functional food offer real business opportunities for…pharmaceuticals? How far apart are the two industries. Are there real synergies to be found or are the two industries antagonistic?
Abstract: No one can deny that pharmacists and pharmacies play an important part in the health of the nation. The pharmacists need to face up to the changes in entrepreneurial needs more than others because of their professional nature and the marketing strategy they need to adopt to keep up with the competition. This group of entrepreneurs due to increase in prescription charges in the last few years had to undertake a close examination of the service…being offered, and how it can be improved or changed. This paper investigates the implications of Government's medicine policies and entrepreneurial skills, the business attitude of the pharmacists and the new skills they will need in the future. The present government policy of increasing the real cost of prescription charges and of imposing budgets on GPs is resulting in help being sought by a significant number of patients from sources other than GPs. To take advantage of this opportunity it is important for pharmacists to undertake a close examination of the service being offered, to see how it can be improved and changed. Certainly the government seems intent on the eventual setting of a very high prescription charge which will encourage self-medication in non-exempt patients, and budget restrictions on GPs will help to reduce prescriptions usage in the exempt population. It could also lead to a major role change to 'pharmacists as doctor' in which responsibility is transferred from GPs for a range of illnesses and offer an extended range of services.
Abstract: This paper analyzes how patients' treatment choices are influenced by cost to the patient for three different diseases in France: mild hypertension, hay fever and hormone replacement therapy. Five focus groups of patients were conducted in May/June 1999. We found that cost conscious behaviors were very dependent on patients' health insurance status, mainly in relation with supplemental insurance. Major shifts of drug treatment decisions differ according to the type of conditions. For hypertensive patients,…differences are mainly observed in relation with the timing of prescriptions, the number of packs and the payment method for drugs. For patients with hay fever, main decision shifts are observed in the choice among professionals and the more or less extensive search for different types of therapies. For HRT patients, main differences in decisions concern the number of packs purchased, how often prescriptions are renewed and which drug categories are prescribed. Overall, cost to the patient was a much more important issue for non-drug treatment costs such as the surveillance costs in the case of HRT patients or for costs of exams and referrals in the case of hypertensive patients. Cost minimization strategies in some ways are dependent on the type of anticipations in the long run that patients may have.
Abstract: Products obtained through techniques that genetically modify living organisms are widely extended in the medical, pharmaceutical and food industry. However, the usage of such techniques has led to widespread controversies in some European countries where it clashes with small public acceptance. Lack of knowledge also suggests that once people become aware of the possible effects on health or the environment that these risks pose this might cause conflicts in many countries. Moral concerns and lack of…sufficient knowledge to understand both risks and benefits are typically the issues that policy makers fear. This paper empirically examines the acceptance of and perceptions of risks for biotech procedures using data from two public opinion surveys, developed in 1996 and 1999 respectively (Eurobarometer surveys 46.1 and 52.1). Additionally, we look at risk perception determinants.
Abstract: This paper looks at the role of intellectual property rights in determining the relationship between market structure and R&Dintensity. Empirical evidence has for a long time provided mixed results about this relationship. Sutton's work in "Technology and Market Structure" (1998) presented a seminal contribution in the field. His theory suggests that whether concentration is high in R&Dintensive industries essentially depends on the substitutability of products associated with different technologies. If substitutability is…high then an increase in the effectiveness of R&D increases the lower bound to concentration; otherwise concentration may stay low. We argue that in those industries where knowledge can be securely transferable this relationship is not robust. Furthermore we present empirical evidence from the pharmaceutical industry that supports our hypothesis.
Keywords: market structure, technology, intellectual property rights, outsourcing, pharmaceutical industry