Pharmaceutical industry legal issues

The basic building blocks of business development deals are, for the most part, contracts. These contain various degrees of complexity depending on the number of elements and parties to the contract. Partnerships and joint ventures are other legal forms with which the business developer will need to become familiar. Another part of the law which you will need to be familiar is intellectual property law which, in the pharmaceutical industry, underlies most of the value of the products. Some of the practical issues that need to be addressed by business development will be discussed in this book, but no attempt to pre-empt legal advice or interpret the legal mind will be made. 

To assist medicinal chemists in their understanding of combinatorial chemistry and to help with the acceptance of a universally understood language, a Glossary of Combinatorial Chemistry Terms was published in Pure and Applied Chemistry and subsequently, in the Journal of Combinatorial Chemistry. This ensures its use within the American Chemical Society as a standard glossary of terms. Further work is focused on producing an opinion document on the legal implications of patenting virtual libraries. This is a very important issue which has profound implications for research and development in the pharmaceutical industry. 

The voluntary self-regulation of the Pharmaceutical Industry or FSA code is based on the recommendations of the collaboration of physicians issued by the German Association of Research-based Pharmaceutical Companies (VFA), the German Federal Association of Pharmaceutical Manufacturers (BAH) and the German Association of the Pharmaceutical Industry (BPI). Although these recommendations have no legal authority, member companies agree to abide by this code. 

The Association of the Pharmaceutical Industry, Farmindustria, has issued a code of practice containing provisions for the advertisement of prescription-only medicines. This code of practice is not legally binding and applies only to members of the association. 

Farmaindustria is the trade association of pharmaceutical industries and represents most of the pharmaceutical industry in Spain. The association has issued a self-regulatory code, The Code on Good Practices for the Promotion of Medicines , which provides clear guidance on industry practice. This code is binding on the association members and therefore important, although not legally binding. 

Patents in the Pharmaceutical Biotechnology Industry Legal and Ethical Issues... 

In addition, a reality of the pharmaceutical industry at present is the outsourcing of some of all of the synthetic chemistry for a project. To the list of existing questions must be added several others. Which contract research organization(s) will you choose, and what can they be expected to accomplish How will you handle electronic lab notebooks, documenting intellectual property issues and other legal issues How do you handle the logistics of quality assurance, shipping, and customs To help you address each of these, it is prudent to reach out into your broader network to get opinions from others not only in your company but also across the industry. 

This chapter will provide the reader with an overview of patenting in the pharmaceutical biotechnology industry and summarize some of the key legal and ethical issues related to the patenting of biomedical products and processes. It will examine the legal aspects of patenting before considering the ethical and policy issues. This essay will focus primarily on the U S patent laws, which are very similar to the European patent laws. The essay will note some differences between the US and European laws, and it will mention some relevant international intellectual property treaties. 

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