OHR’s Statement at the International Agencies’ Joint Press Conference in Banja Luka

BiH Citizens’ Safety
Must Come First

The BiH Law on
Pharmaceuticals and Medical Devices will be considered by the
Constitutional-Legal Committee of the House of Representatives tomorrow. This
law will regulate the sale and manufacture of drugs throughout the country: one
of its principal objects is to make medicine safer and cheaper.

At present, the Entities have
different laws and rules governing the manufacture and sale of medicine and
medical devices, and Brcko has none. The result of this fractured pharmaceutical
market is that medicines in BiH are not as safe as they should be, and
investment in developing new medicines is not as high as it could be. This is
jeopardizing the health of the people of BiH – and it need not be so.

The new law, which will be
considered tomorrow, was drafted by pharmaceutical and legal experts delegated
by the State, the Entities and Brcko and is fully supported by the responsible
authorities and the International Community (its passage was urged by the Peace
Implementation Council in its 23 June Communiqué). It is fully in accordance
with EU standards and directives – and will bring BiH into line with the
European Union’s acquis communitaire. BiH and international
manufacturers, as well as EU pharmaceuticals experts actively participated in
preparing the draft.

The law will create a single
pharmaceutical market in BiH, establish uniform conditions for manufacturing,
testing and wholesale of pharmaceuticals and medical devices and prescribe
conditions and foresees measures for ensuring their quality, safety and
efficacy. It will also introduce supervision over the single market and
establish a State Pharmaceutical Agency as its regulator.

I would also draw your
attention to the fact that this law is crucial for the implementation of the BiH
Law on Prevention and Suppression of the Abuse of Narcotic Drugs – which is at
the heart of everything now being done to tackle drug addiction in

OHR notes with great concern that proposed amendments to the
law, which will be discussed tomorrow, would – if adopted – undermine its basic
principles. Provision for the location of the State Pharmaceutical Agency
headquarters in

Banja Luka and the Control Laboratory in


will ensure that these
agencies can be launched quickly and will also ensure an optimal division of
labour. In addition, measures have been agreed that will protect domestic
manufacturers while ensuring that citizens get the benefits of a free market –
safer medicines at fairer prices.

Any deviation from these key
issues would cast doubt not only on BiH’s SAA compliance, but the well-being of
BiH citizens and their access to high quality domestically produced

The BiH Law on
Pharmaceuticals is about making cheap and safe medicine available to citizens –
parliamentarians are honour bound to enact this crucial piece of legislation
before the summer recess.


RS Higher Education Law
a Blow to University Students

The RSNA on Wednesday enacted
a Higher Education Law. This law deals with issues that are dealt with in the
BiH Higher Education Law, which will be discussed at tomorrow’s session of the
Constitutional and Legal Committee and by the House of Representatives next

The passage of an Entity
Higher Education Law at this point will simply plunge the BiH education sector
into confusion – thus further damaging the interests of students. It does
nothing to help BiH’s integration in the European Higher Education

RS Prime Minister Dodik has
given assurances that his government will prioritise the enactment of a BiH
Higher Education Law – which will regulate university standards throughout the
country and complete the implementation of the Bologna Process. The RSNA has
chosen to ignore the prime minister.

OHR continues to believe that
there is a possibility of compromise if the BiH Higher Education Law is adopted
as early as next week. The new RS law could then be harmonized with the state
law. The OHR therefore urges the BiH parliamentarians to enact this law without