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E-DRUG: Mandatory generic prescribing vs trade mark rights

Bada,

Interesting question. As you know we tried to do this in Zimbabwe without
success and I will discuss that later.

        In terms of the legal challenge. I am sure that it depends on your law
or regulations about what is a legal prescription. In all countries there are
regulations which define that a prescription must have the date the doctors
name and address, name and address of patient, age under 12, signature etc
etc. The BNF has a nice description on Page 4 of what is a legal
prescription. If these regulations state that the doctor must write the name
of the drug in generic terms I am sure it will be legal. The drug may well
be patent protected and the drug dispensed will be the brand name variety.
If the drug is no longer patent protected then I do not believe that the
company has any grounds for arguing. The definition of what is or is not a
safe prescription is clearly a state responsibility. Even under the GATT
agreement states have a public safety exemption clause to protect their
populations.

        Having said all that do I think you should try to enforce generic
prescribing in the private sector? And my answer is regrettfully NO. We
tried to do it in Zimbabwe and we failed. The main reason we failed is that
the Drug Regulatory Authority did not support the change and obstructed the
change at every opportunity. Also they did not have the power to enforce the
regulations. Can you imagine a drug inspector hauling a specialist physician
into court for doing what he has always done. The Philippines tried to do
this with only limited success and great political cost. In some countries
eg Tanzania, generic prescribing has increased due to price reasons. People
just cannot afford the brand name equivalents.

        So what do I think should be done. Firstly generic prescribing,
dispensing, education and training in public sector  is a MUST. Also copying
the American model of requiring pharmacists to offer generic substitution to
all patients may help. In the Philippines the EDP program survey pharmacies
and publish the costs of widely used drugs in the newspapers. This clearly
shows the generic brand name price differentials. 
If you have price control regulations you may want to allow a differential
mark up to encourage generic dispensing. For example if your price
regulations allow a 33% mark up on drugs you could change that to allow 25%
on brand name drugs and 40 or even 50% on generics. The base price for the
generic is lower and so the patient will stay pay less and the pharmacist
will make a bigger percentage profit so they will have an incentive to
substitute.

        The key issue is that many drugs used in the private sector are
patent protected and generic prescribing does not offer great savings. Where
they are not the companies have had 17 (previously) now 20 years to recoup
their drug costs. Also the whole of Africa is only 3-4% of the global
pharmaceutical market so the amount that the drug companies could recoup is
negligeable. Also if the companies were spending their money on research
relevant to Africa such as malaria, TB etc they might have a better case but
they do not.

        So I would work towards public sector generic drug use and in the
private sector mandate generic substitution unless the doctor writes out in
full legible handwriting "Do not substitute without consulting me."

        I think this is a very interesting issue to discuss and I would be
interested to hear comments from other countries and from the drug industry.

Good luck

Richard Laing

Richard Laing                                           Tel (617) 353-6630
Department of International Health              Fax (617) 353-6330
School of Public Health,                        e-mail richardl@bu.edu
Boston University,
53 Bay State Rd,
Boston
MA 02215 USA


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