Utente:Gianreali/prova 19

Test data exclusivity si riferisce alla protezione dei dati clinici che devono essere sottoposti ad una agenzia regolatoria, per provare la sicurezza e l'efficacia di un nuovo farmaco, e per prevenire che i manifattori di farmaci generici si basino su questi dati nelle loro applicazioni. Le compagnie farmaceutiche sostengono che visto che i dati farmaceurici sono così costosi da prodursi, è un vantaggio ingiusto permettere alle altre compagnie di basarsi su questi dati senza costi.

refers to protection of clinical test data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications. Pharmaceutical companies argue that since test data is so expensive to produce, it is an unfair advantage to let other companies rely on that data without cost. Critics charge that it can act as a restriction to producing a generic copy; that although it would not raise prices of drugs, it would prevent prices from falling due to generic competition; and make it more costly for the poor to gain access to life-saving drugs (e.g. anti-HIV & anti-malarial medications.) Developed countries with innovative pharmaceutical industries (including the United States) have sought data exclusivity provisions in Free Trade Agreements with their trading partners, e.g. DR-CAFTA which includes such a provision.

According to the European Commission:

""Data exclusivity" refers to the period during which the data of the original marketing authorisation holder relating to (pre-) clinical testing is protected. Accordingly, in relation to marketing authorisation applications submitted after 30 October 2005 for the applications filed in the framework of national procedures or 20 November 2005 for applications filed in the framework of the centralised procedure, 'data exclusivity' refers to the eight-year protection period during which generic applicant may not refer to the information of the original marketing authorisation holder and 'marketing exclusivity' refers to the ten-year period after which generic products can be placed on the market. However, in relation to marketing authorisation applications submitted before the above mentioned dates, the wording 'data exclusivity' refers to the six or ten-year protection period granted to the original MA holder before generic applicants can file their applications for marketing authorisation."

One critical issue in this regard is the issue of data exclusivity for pioneer drug companies (pharmaceutical R&D organizations). From the standpoint of economics, industries where the R&D process is costly and risky, need longer exclusivity periods to realize innovation benefits, compared to those industries where innovation is easier and less costly. However, data exclusivity provisions has effect on several other aspects of the society and nation including but not limited to human rights and access to medicine, promotion and development of a nation, and domestic & international trade.

Data Exclusivity Period

United States: 5 Years (7 years for orphan drugs, +6 months for pediatric drugs)
European Union: 10 Years (+ 1 year for new indication)
Japan: 6 Years
China: 6 Years