Parallel Imported Drugs

The Pharmaceutical companies want to maximise there profit on drugs. To do this there might be price differences between markets and countries. In this case another pharmaceutical company can buy the drug in one country and sell it in another. Despite the costs for re-labelling and repacking there might be a profit for the parallel importing company. An example is shown in Table 8.1. 

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Pharmaceutical innovation has made a decisive contribution to the reduction of mortality and the improvement of quality of life. The role of patents in providing incentives for innovation has been crucial. Yet at the same time there are limitations that need to be overcome in the future. Here we will mention just two examples orphan drugs and parallel imports. Patents do not offer incentives to develop drugs for low-prevalence diseases, known as orphan drugs. Governments are sometimes faced with the option of public production, as the private sector does not invest in them. Yet these would be precisely the cases in which experiments would be conducted with new models for promoting innovation, as discussed in this chapter. 

Kristina M. Lybecker focuses on the tensions inherent in the socioeconomic construct that is today s pharmaceutical industry. On the one hand, it has a social contract to develop medicines that enhance the health of the public, but on the other it seeks to maximize profit. Lybecker explains the major challenges facing the industry today, such as longer drug development times, rising R D costs, generic competition, and parallel importation. 

The pharmaceutical marketplace has also become more crowded as innovative pharmaceutical firms compete with a growing number of generic producers as well as their own products via parallel importation. The passage of the 1984 Drug Price Competition and Patent Term Restoration Act (The Hatch-Waxman Act) intensified... 

TRIPS-plus provisions in FTAs regularly include limits on compulsory licensing prohibitions on parallel imports limiting market approval for generic drugs data exclusivity extended patent terms and evergreening" provisions. Since the U.S. often... 

The Business Day (a newspaper for the business community in SA. Available at www. bday.co.za) reported on measures the MoH would use to pave the way for cheaper medicines. Here mention was made of the establishment of a Pricing Committee with a clear mandate to start a transparent pricing system, examining the prices of drugs in other countries, advising the MoH on parallel importation of medicines and sourcing cheaper medicines from outside SA, amongst others (Kahn 2003). 

South Africa s 1997 Medicines Amendment Act authorizes two practices that are controversial (although not explicitly prohibited) under trips. One is parallel importing, which allows importers to buy pharmaceutical drugs from the cheapest sources available abroad, regardless of whether the patent-holders give their... 

There is a fast lane for new drug approvals if the product is already in at least one of the following jurisdictions the United Kingdom, Canada, United States, Sweden, or Australia. Approxmately 85% (by value) of pharmaceuticals go through the nearly 3,000 community pharmacies. Yet, approxmately 80% of the population rely on the public sector for drugs, received through clinics, hospitals, primary care posts, or military facilities. Although there is a 20-year patent period of exclusivity/protection, the parallel imports option effectively defeats this protection. 

The most pertinent issue in drug regulatory affairs is the question of parallel import. Pharmaceutical regulations until now have not allowed this, but since recently affirmed legislation particularly encourages parallel import, the old regulations will have to be amended. This probably will affect various aspects of the regulations and directives. 

In theory the constitution or quality of a manufacturer s drug may prove to be somewhat different in various countries, and manufacturers objecting to the parallel importation of their products have sometimes made his point in practice, however, any differences which exist relate only to particular excipients or colouring agents or to the language of the packaging text, ft is now in any case common practice for parallel products to be examined and approved by the regulatory authorities to establish the fact that they are indeed identical to the version imported officially. 

A crucial issue for antiviral therapy is the fact that all antiviral substances rapidly select for resistance thus, monitoring and overcoming resistance has become a most important clinical paradigm of antiviral therapy. This calls for cautious use of antiviral drugs and implementation of combination therapies. In parallel, efforts in drug discovery have to be continued to develop compounds with novel mode-of-action and activity against resistant strains. This book reviews the current status of antiviral therapy, from the roads to development of new compounds to their clinical use and cost effectiveness. Individual chapters address in more detail all available drug classes and outline new approaches currently under development. 

TOF-SIMS has important potentials in many areas of life science, in fundamental and applied research as well as in product development and control. This holds for the characterization of biological cells and tissues, of sensor and microplate arrays, of drug delivery systems, of implants, etc. In all these areas, relevant surfaces feature a very complex composition and structure, requiring the parallel detect ion of many different molecular species as well as metal and other elements, with high sensitivity and spatial resolution requirements, which are exactly met by TOF-SIMS. 

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