Ministerial Decree on usage of essential information and data in relation to innovation in Pharmaceutical Products

Ministerial Decree on usage of essential information and data in relation to innovation in Pharmaceutical Products

The UAE has always been on the forefront of innovation and economic diversification in order to maintain a robust IP mechanism. In relation to this a Ministerial Decree was issued in the month of September by the Ministry of Health and Prevention. Decree 321 of 2020 was promulgated to regulate and control the usage of essential information and data that relates to innovation in pharmaceutical products that are registered in the UAE.

For a period of eight (8) years from the date of marketing approval in the UAE, the marketing authorisation holder has exclusive rights to the data and information surrounding the pharmaceutical product. This is known as the “Data Exclusivity Period”.

Decree 321 affords generic companies a marginal exception in spite of the Data Exclusivity period for the sake of public health or any other reason as decided on a case to case basis.  It incidentally discards the recognition of patents of origin as a catalyst to restrain generic companies for products that have been registered or approved after the publication date of the new Decree. The Decree 404 will apply only to pharmaceutical products that have been registered or approved before the New Decree Publication Date.

This Ministerial Decree proclaims that a marketing approval can be applied for by generic companies within 2 years prior to the expiry of the Data Exclusivity Period. This can be done only if evidence of the lack of a legitimate and valid patent protection, in the UAE, with regard to the original drug can be produced before the government. The Ministry of Health had issued the Decree 404 in 2000 in relation to pharmaceutical patent registration.

The Decree will come into effect as soon as it has been published in the UAE Official Gazette. This is expected to take place in the month of October.

Patent protection in the UAE is extremely necessary for pharmaceutical companies to safeguard themselves against generic companies inside the UAE and in turn place less reliance on patents of origin.