Data Exclusivity in European countries

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Friends this is about the data exclusivity provision available in European countries. The details mentioned below is taken from http://www.egagenerics.com/gen-dataex.htm which has given very descriptive details and give you better understanding of the Data exclusivity in Europe. What is Data Exclusivity? Data exclusivity guarantees additional market protection for originator pharmaceuticals by preventing health authorities from accepting applications for generic medicines during the period of exclusivity. The effective period of market exclusivity gained by the originator company is the period of data exclusivity (currently 6 or 10 years) plus the time it takes to register and market the generic medicine -- a further 1 to 3 years. Data Exclusivity was introduced in 1987 to compensate for insufficient product patent protection in some countries. However, strong product patents are now available in all 27 EU Member States. The rules on data exclusivity have been changed in the new EU pharmaceutical laws adopted in 2004. Generics Do Not Use Originator Data Data exclusivity prevents the regulatory authorities from assessing the safety and efficacy profile of a generic application for a period of time beginning from the first marketing approval of the originator product. Generic medicines applications do not include data from the originator registration file. They are approved on their own merits, using their own development data, under the same EU requirements as the originators. The originator's data is never released to third parties by the medicines authorities. It therefore is not and cannot be used by generics producers. However, since generic medicines contain well-known, safe and effective substances, unnecessary animal testing and clinical trials on humans performed by the originators are not repeated. Instead, regulatory authorities evaluate the generic application against the originator documentation on file -- but only after the period of data exclusivity has expired. This assessment is carried out internally by the authorities. In no instance is the originator's research data released or disclosed to the generics producer or anyone. The generics manufacturer never sees the originator data. Data Exclusivity is Not Data Protection Data exclusivity has nothing to do with protecting research data. Long after the data exclusivity period has expired, the originator documentation remains protected by copyright laws and other legal provisions. Data exclusivity merely extends the originator company's market monopoly over a product by not allowing the authorities to process an application for marketing authorisation. Current Legal Framework Under Directive 2001/83/EC, EU data exclusivity laws guaranteed market protection for originator medicines for either 6 or 10 years. Data exclusivity extends for six-years after European marketing authorisation is granted in Austria, Denmark, Finland, Greece, Ireland, Portugal, Spain, Norway and Iceland and is the period adopted by the 12 new Member States during their negotiations for EU accession. Ten-year periods of exclusivity were operated in Belgium, Germany, France, Italy, Luxembourg, the Netherlands, Sweden and the UK. A ten-year period was also granted to an originator gaining marketing approval through the Centralised Procedure. New Legal Framework Harmonisation of the data exclusivity period and addition of new periods of data exclusivity The New EU Pharmaceutical Legislation adopted in 2004 has created a harmonised EU eight-year data exclusivity provision with an additional two-year market exclusivity provision. This effective 10-year market exclusivity can be extended by an additional one year maximum if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. This so called 8+2+1 formula applies to new chemical entities (NCE)s in all procedures and to all Member States (unless certain new Member States are awarded derogations, which they can request following publication of the new law). In practical terms, this means that a generic application for marketing authorisation can be submitted after Year 8, but that the product cannot be marketed until after Year 10 -- or 11. New EU Data Exclusivity Rules Adamant opposition to this overall increase in data exclusivity was expressed by the countries with six-year regimes -- especially by the Accession countries, who had not agreed to this law in their accession agreements, were not yet entitled to vote on it during the legislative process, and who felt it would have a significant effect on their governmental medicines expenditure. Consequently, an additional clause was inserted into the legislation at the last minute making the law prospective. As a result, the new periods of data exclusivity only takes effect for reference products applying for marketing authorisation after the new law entered fully into effect (ie, since November 2005). Therefore, the first generic medicines applications under the 8+2+1-year data exclusivity period will not occur until late 2013. The revised legislation also provides a one-year data exclusivity provision for products switching from "prescription-only" to "over the counter" (OTC) status, on the basis of new pre-clinical or clinical data. The law also grants one-year data exclusivity for any new indication for a product which can demonstrate well-established use. This latter provision is non-cumulative, and as such covers only the use of the new indication).

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