تجارت موازی داروسازی: بررسی جنبه های حقوقی، اقتصادی، و سیاسی

Objectives An overview of the status quo of parallel trade of pharmaceuticals (pharmaceutical parallel trade [PPT]) was performed. The different economic, political, and legal viewpoints as well as the public health perspective are being taken into consideration. Analysis is being undertaken on a worldwide level, focusing on the situation of Switzerland in the context of current developments in the United States as well as in the European Union (EU). Methods Desktop analysis using publicly available information (e.g., scientific literature, congress reports, official statistical databases) was performed during the years 2006 through 2007. Such gathered information was compiled and systematically structured to allow a crude overview of the development of intellectual property law in the last 100 years (as a prerequisite under which PPT legally can exist) as well as a description of the health economic and political context in which PPT is set currently. Results It could be shown that PPT is an ubiquitous phenomenon, appearing in industrialized countries as well as in the developing world. Economically, it has gained a significant weight in substantial parts of the EU in the last decade. This has to be seen in the context of EU efforts of enhanced economic and political integration. The worldwide constant growth of health-care expenditures, with its strain on national health-care budgets, has led to increased discussions about the necessity and consequences including possible dangers of PPT, namely, in the United States and in Switzerland, where up to now PPT has been only of marginal importance. Conclusions The analysis of the value of PPT depends strongly on the importance that is given to different perspectives by the individual analyst. It is clear that an item-centered view of PPT is not able to analyze this phenomenon in an equitable way. Further attempts have to be made to standardize evaluation as well as to increase available information to empower science and decision-makers to perform objective analyses and informed decisions.

This article tries to give an overview of the current international situation of pharmaceutical parallel trade (PPT). Parallel trade is not limited to pharmaceutical products (see later in the article, but because of the special nature of pharmaceuticals, which differentiate them from “normal” consumer goods, there are not only economical facts to be given, but legal considerations and political implications to be remembered. This becomes clear—among others—when analyses of the same phenomenon come to completely different, sometimes even contradictory results, as it is the case with the recent economic studies on this subject, which will be shown next. Part of the reason for such different results could lie in some shortcomings in economic theory as well as in the limited availability of appropriate data. By giving an economic, legal, and political outline, the reader of this article should be enabled to understand the international status quo of PPT as well as the different interests, policies, and aims of the individual market participants. Definition of PPT Parallel trade is a phenomenon well known internationally: A common definition is worded in the fundamental work of Arfwedson [1] as follows: Re-importation (or parallel trade as it is known in Europe) occurs when products protected by patent, trademark or copyright are first placed into circulation on one market, then (re-) imported into a second market without the authorization of the original owner of the intellectual property rights (IPRs). Arfwedson concludes his definition with the remark that “Myriad products are re-imported, includingautomobiles, clothing, perfume and other consumer goods.” This shows to us that parallel trade is an almost ubiquitous phenomenon (at the end of the last decade, it was estimated, for instance, that up to 20% of the market for Coca-Cola in the UK was served by parallel imports coming from wholesalers in other European countries [2]).

In general, parallel trade of pharmaceuticals remains a frequently discussed topic. Results and conclusions of research in this field are very different, sometimes even contradictory. This could be due to the fact of sponsoring of studies by different stakeholders. To name the three most important recent studies on parallel imports: while the York and Odense studies have been sponsored by the European Association of Euro-Pharmaceutical Companies, the parallel importers’ European representative, the LSE study, was sponsored by Johnson & Johnson, a pharmaceutical company. Parallel trade of pharmaceuticals takes place in a playground with different stakeholders having different and contradictory interests: the multinational pharmaceutical industry with their interest of maximizing profit; national governments with the interest of keeping a research-based industry offering high number of qualified jobs on the one hand, and on the other hand keeping costs for health care low, or at least, reduce their growth; health insurers (and their clients!) heading for low monthly fees; and last but not least, parallel importers to make use of the existing legal possibilities to realize profits out of price differentials. Parallel imports depend on the legal environment of an economic area. This is even more the case with pharmaceuticals, because of the highly regulated distribution of drugs. Drug prices remain a target of politicians worldwide, because of their visibility and to the relative ease with which this sector of the healthcare industry can be manipulated. On the other hand, the economic power of the pharmaceutical industry, especially of the big globally acting companies, is of influence, especially in countries where pharmaceutical industries are big taxpayers and providers of qualified workplaces. Because of this, parallel trade remains an issue in the EU and will become a greater issue in the United States and in Switzerland, two countries with high drug price levels and a very strong pharmaceutical industry. Further research is needed to investigate this field in the most objective manner possible. To do this, it is of prime importance to standardize evaluation methods, as well as to increase quality and quantity of available objective information to empower science to perform sound analysis and to enable decision-makers to implement informed and well-balanced decisions.