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Letters to the Editor
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Control of entry
Still time for effective lobbying
From Mr J. Ferguson, FRPharmS
There are a few additional points that should be considered alongside
the article “New European policy could abolish control of entry
whatever NHS wants” (PJ, 23 October, p600).
The authors are right to draw attention to Article 14(5) in the draft
directive on services in the internal market. Article 14 as a whole sets
out “prohibited requirements”, ie, requirements that a member
state is prohibited from applying in deciding access to a service activity.
Article 14(5) is the prohibited requirement that could affect the control
of entry provisions. This, as the authors of the article state, bars “the
case-by-case application of an economic test making the granting of an
authorisation subject to proof of existence of an economic need or market
demand or an assessment of the potential or current economic effects
of the activity, or an assessment of the appropriateness of the activity
in relation to the economic planning objectives set by the competent
authority”. As stated, the Department of Health is not clear on
whether the control of entry provisions would be caught by the directive.
On the face of it, considering Article 14(5) on its own, there appears
to be every likelihood that they would be.
However, Article 15(2) in the draft directive sets out “Requirements
to be evaluated”. Member states are required to “examine
whether their legal system makes access to a service activity or the
exercise of it subject to compliance with any of the requirements listed”.
If it does, a member state must inform the Commission of any requirements
that it intends to maintain and the reasons why it considers that they
comply with the conditions specified in Article 15(3). It must under
these conditions be non-discriminatory (in relation mainly to nationality),
be necessary (objectively justified in the public interest) and be proportionate
(not go beyond what is necessary to obtain the objective).
Article 15(2)(a) specifies that a requirement to be evaluated is “quantitative
or territorial restrictions, in particular in the form of limits fixed
according to population or a minimum geographical distance between service
providers”. A number of EU member states control the distribution
of pharmacies in their countries by applying one or other of these criteria.
Under the directive, they would have to state why they would wish to
retain these controls. It would surely be unreasonable that member states,
which wish to retain such controls, should be able to retain them if
they can show they comply with the tests in Article 15(3), while the
UK would have no such opportunity to justify the “right of entry” controls
applying the same criteria. In practice, these control the distribution
of new pharmacies, because few are economically viable without an NHS
contract.
There is another important point, which was made strongly by the French
Order of Pharmacists at the hearing on the draft directive before the
Economic and Social Committee of the EU on 24 May last. This was that
under the current sectoral directives on free movement of pharmacists,
the geographical distribution of pharmacies is a matter not for the EU
but for individual member states. Interestingly, this provision has been
carried over to the new draft directive on recognition of professional
qualifications, on which political agreement has already been reached
by the Council of Ministers. No such political agreement has been reached
to date on the draft directive on services. In “Whereas 13” of
the draft directive on services, it is recognised that where a service
activity is already covered by other community instruments, appropriate
provisions should be laid down “including provisions for derogations,
in order to prevent incompatibilities and to ensure consistency as between
all those Community instruments.”
There is to be a public hearing on this draft directive before the European
Parliament on 11 November. There is therefore still time for effective
lobbying both at EU and national level. Support of the DoH should be
sought for lobbying the Department of Trade and Industry. That strategy,
it would appear, succeeded in securing an exemption for medicines in
the draft regulation on promotion of sales, the intention of which is
to sweep away all restrictions on promotion of sales of products.
John Ferguson
Haywards Heath, West Sussex
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The
Pharmaceutical Journal