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Health systems in transition
Portugal
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The MoU, signed in May 2011 under the Economic and Financial Adjustment
Programme for Portugal, brought important changes to pharmaceutical policy.
First, it set targets for public pharmaceutical expenditure. Second, it required
changes to the structure of distribution margins. These two demands constitute
new approaches to containing high public pharmaceutical expenditure growth.
Additional requirements of the MoU included: the promotion of generic drugs,
the use of clinical guidelines and the redefinition of the international referencing
rules that establish prices of new pharmaceutical products. The latter is now
focused on the prices in the three countries with the lowest prices in Europe,
but which have some broad similarities with the Portuguese economy.
The MoU set clear targets for public pharmaceutical expenditure: the
Portuguese government should decrease such expenditure in both the hospital
sector as well as in ambulatory care. The target was 1.25% of GDP by the
end of 2012 and 1% by the end of 2013. However, Portugal’s total public
pharmaceutical expenditure at the end of 2011 was 1.35% of GDP, and only in
2014 was it possible to achieve 1.23% of GDP.
5.6.3 Pharmaceutical prices
In Portugal, following market authorization, an international reference pricing
system is applied to define the maximum market price. After this price is set,
the pharmaceutical company can apply for the new product to be included in
the positive list for reimbursement by the NHS. This price cannot be higher
than the initially approved price.
The way prices are set was also subject to change. The international reference
pricing system prevailing before the MoU used the average price of the same
product in four reference countries (Spain, France, Italy and Greece). The MoU
required a redefinition of the system to use the lowest price of a set of three
countries to be chosen based on the level of prices prevailing in their markets
and which have a comparable GDP to Portugal.
Increasing the use of generics has been one of the most relevant cost-control
goals of pharmaceutical policy in Portugal. Several measures included in the
MoU aimed to increase competition from generics, focusing on price regulation
of the market and administratively forcing lower prices. The measures included:
setting the maximum price of the first generic to enter the market in its class
at 60% lower than the price of the originator product (initially, it was set at
50% but changed later); automatic reduction of the price of the originator
pharmaceutical product when the patent expires; resolving the legal dispute
over intellectual property to ensure faster entry of generics on the market; and