Generic medicines

The authorisation of generic medicinal products is covered by Article 10 of the Human Medicines Directive 2001/83/EC and Article 13 of the Veterinary Medicines Directive 2001/82/EC. A generic drug is defined as a medicinal product that has ... 

The company that applies for approval of the generic product must present full chemical and pharmaceutical documentation. If the new product does not fall within the definition of a generic medicinal product compared to the reference product the results of the appropriate pre-clinical tests or clinical trials should be provided (EU 2001 specific Article 10 (3)). It should be noted that the pharmaceutical and chemical quality is strictly regulated and includes all medications. 

Table 8.1 Examples of original and generic medicinal products...

Florence AT. Generic medicines a question of quality. In WeUs FO, D Arcy PF, Harron DWG, eds. Medicines Responsible Prescribing. Belfast The Queen s University, 1992 63-83. 

There is a reordering of the information to be included in the SPC. With regard to generic medicines, the final paragraph of Article ii states that for authorisations under Article 10, those... 

The scheme applies to all companies suppl)dng NHS medicines prescribed by medical or dental practitioners or nurses qualified to prescribe. Generic medicines, whose price is determined by the Drug Tariff, are excluded, as are the over-the-counter (OTC) medicines, and sales of medicines derived from private (non-NHS) prescriptions. 

The prices of generic medicines must inevitably rise in the near future as manufacturers move to produce patient packs, which will be required to contain patient information leaflets. Under EC legislation, bulk containers will almost inevitably be phased out of production (except perhaps for hospital use). 

Walker R. Generic medicines reducing cost at the expense of quality PharmacoEconomics 1995 7 375-7. 

That argument was first famously raised by the then U.S. FDA Commissioner Mark McClellan before the First International Colloquium on Generic Medicine in Cancun, Mexico (September 25, 2003). It was raised again by the Republican Policy Committee of the United States Senate (2005). Its policy statement, Pharmaceutical Price Controls Abroad An Unfair Trade Policy, cited the 2002 U.S. Trade Promotion Authority Act, which acknowledged that price controls and reference pricing for pharmaceutical products (to be discussed below) are trade-distorting... 

In the next section we are concentrating on giving general overview of registration requirements for two major groups of medicines innovative (originator) and multisource (generic) medicines. 

In the context of generic medicines it is appropriate to ask what is a pharmacopoeia (word is derived from Greek pharmako-poios drug-maker ) and how it fits in nowadays regulatory systems The answer to this question may seem obvious, but the term pharmacopoeia is used in a varied way... 

Table 3. Regulatory requirements for multisource (generic) medicines...

Generic policies are effective instruments when a patent expires. In the United States of America the average whole sale price falls to 60% of the price of the branded medicines when one generic competitor enters the market, and to 29% when 10 competitors. To introduce and expand the use of generic medicine products, it is important that (1) supportive regulations exist, (2) reliable quality assurance is in place. 

Warren Kaplan argues that we should expect hybrid structures to appear in the pharmaceutical industries of the important middle-income producers of generic medicines (e.g., India). Notwithstanding the possible effect of these structures on pharmaceutical innovation in middle-income countries, this restructuring is likely to have important consequences for access to affordable medicines. The effect of these hybrid structures on real pharmaceutical innovation in the established pharmaceutical industry and in the newer public-private initiatives is still unclear. 

Agreement. Journal of Generic Medicines 2 316-326. Available at www.ssrn.com [Accessed February 5, 2006]. 

Furthermore, a condition of importing generic medicines, manufactured in another country, under paragraph 6 (WTO 2003) requires that the importing country issue a compulsory license for that medicine. A compulsory license can only, in effect, be issued by a nation that grants patents on that medicine. There are two problems inherent in this. First, many of the poorest countries cannot afford a patent system and thus cannot grant pharmaceutical patents. Second, many companies do not expend... 

There are already serious questions about the relevance and suitability of TRIPS minimum IP standards for developing countries (CIPR 2002 UNDP 2003). The gross inflation of these standards in "free trade" agreements severely limit national strategies to provide affordable medicines and limits market access for generic medicines, irrespective of the country s level of development or disease burden. These practices not only raise serious ethical concerns, but also sharply curtail country capacity to realize the right to health for all. 

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