Abstract
The UAE Ministry of Health is planning to establish a National
Pharmocovigilance Committee in Q309. Significantly, the division will be
within the Ministry of Health building in Dubai, allowing for
communication between departments and therefore a more efficient surveillance
process for marketed pharmaceuticals in the Emirates. BMI notes the
emerging markets are rapidly recognising that having a centralised system
for reporting adverse reactions to medicines will attract multinational
pharmaceutical firms looking to reduce risk when entering new
countries. The new committee is also expected to deal with safety testing
pharmaceutical products to be used in the UAE, and to provide consulting
and information services on drug registration and related processes within
the country. Encouragingly the planned committee will have a database where
records from smaller health bodies can be updated, which will also be used
for international co-operation with other governmental pharmaceutical
authorities and the World Health Organization (WHO). The UAE government
has previously asserted that its heavy reliance on imported pharmaceuticals
needs to be redressed with an increase in domestic manufacturing.During
April 2009, indigenous drugmakers stated that the government needs to
encourage more medicine manufacturing in the country through a more
unified regulatory process within the Gulf Co-operation Council (GCC) states,
and further through financial support. We note that perceptions of
Emirati residents being able to afford patented drugs are changing and
that the Middle East should be highlighted as a high-growth potential
region for generic drug companies looking to boost global sales as part of
their growth strategy. We believe that another area for urgent review is
the lack of drug safety testing within the Emirates. While relying on
internationally qualified medicines saves money on implementing safety
protocols in the country, it paradoxically leaves the UAE reliant on more
expensive US FDA- or European Medicines Agency (EMEA)-approved
pharmaceuticals, which have to be imported. In addition, multinationals
present in the UAE, including Pfizer, have emphasised that joint ventures with
indigenous manufacturers are only viable options if they comply with GMP
criteria. BMI reinforces that collaborative investments like this are an
attractive method of stimulating local production while maintaining foreign
interest and should be considered by the government as a simultaneous
means of boosting the sector.
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