Russia plans to raise tax on imported pharmaceuticals

POLICY AND PEOPLE FDA proposes

easing of promotion

FDA proposes to allow drug, and biologicals manufacturers, in certain instances, to distribute journal articles that mention off-label uses. The agency made it clear that it did not think that it was keeping vital information from getting to health providers. It said that off-label data could be obtained from several sources. If drug manufacturers could disseminate information on unapproved uses, they would have less incentive to conduct costly trials of safety and efficacy, said the FDA.

The device,

Australians revise

rules

The new policy would allow drug makers to disseminate the results of well-controlled studies used to secure FDA approval, and that has been published in peer-reviewed journals. If the articles contain effectiveness rates, data, analyses, uses, regimens, or other information not in the approved labelling, the differences would have to be clearly stated on the reprint. The agency is soliciting comments until Jan 19. Alicia Ault Barnett

Informing UK patients about their medicines Jan patients in the UK will receive some of their medicines in special packs containing an information leaflet or label. This move marks the start of a new scheme that will bring the UK into line with European legislation, which requires that by December, 1998, patients are given detailed written information about prescribed drugs. Pharmacists will no longer buy medicines in bulk and repackage them but will dispense them in manufacturers’ original packs containing a supply for a fixed 1

From -

treatment

period.

Russia

New make

needs.

Import duties on drugs were waived in the early 1990s, because of huge shortages throughout the then Soviet Union. The main reason for the shortfall was the closure, under pressure from the new ecological movement, of several large, highly polluting, pharmaceutical plants. The disintegration of the Soviet Union should not, of itself, have left Russia ill-provided; 85% of all Soviet pharmaceuticals were produced in what is now the Russian republic. However, plants

obsolescent. absence of

52

will be for ulcer-

packs healing drugs, lipid-lowering drugs, and systemic corticosteroids. Other categories will be added, up to six every 3 months, over the next 3 years. The full scheme will apply only to drugs prescribed in general prac-

tice. Hospital pharmacists will still be allowed to repackage drugs, but they will be required to give written information with any medicines dispensed to outpatients and to inpatients on

discharge. Dorothy

Bonn

state governments will be made more accountable federal funding they receive for public hospitals. Under the Medicare the arrangements, Commonwealth agrees with the

Aforustralian soon the states to

subsidise public hospitals, in

for which the states agree to treat public patients without charge. However, the states have been accused of using federal funds for services that should be financed by the state (see Lancet, 1995; 345: 1229). This and other problems with the agreements were addressed at a return

Commonwealth-state meeting in and it was June, 1995, agreed that the states would be given an additional A$23 million bonus payment over 2 years, in return for which they would agree to targets to be written into the Medicare agreements, such as reducing waiting times for elective surgery. If targets are not achieved, penalties will be applied in the form of a reduced "bonus" payment. The new agreements will be back-dated to July 1, 1995, and will be annually assessed. Peter

Harrigan

plans to raise tax on imported pharmaceuticals

high import duties could Russia a "pharmaceuticalfree zone", the Russian daily Izvestiya has warned. The proposed 30% duty, which the paper said, is the result of lobbying by the domestic drug industry, would price many medicines beyond the means of the average patient. Yet, according to importers, the Russian industry can supply only 15% of the country’s pharmaceutical

many

The first

hospital funding

technologically Taking advantage of the import duties, foreign are now

firms have secured a major share of the Russian market (see below) that they have no wish to surrender. On July 1, 1995, however, the

Russian government

imposed

Principal suppliers of

pharmaceuticals to Rus ia

a

10%

all imported pharmaceuticals. Russian importers maintain that this, and the 30% tax planned for the near future, will not stimulate the domestic pharmaceutical industry in the way that similar measures have helped Russian automobile production. All that will happen, they say, is that the quality of Russian pharmaceuticals will decline (due to the absence of competition), while the prices will remain at "world" levels. To draw the attention of legislators to the problem, a large Russian pharmaceutical supplier, Biotek, mounted an exhibition in early December, in the lobby of the State Duma (lower chamber of parliament), of what it termed the "most effective imported pharmaceuticals"-to coincide with a Duma debate on the issue. A proposal made during that debate was that high duties be imposed only on foreign products for which the local

tax on

industry produces a competing product of similar quality. Vera Rich