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The Pharmaceutical Journal
Vol 271 No 7259 p105
26 July 2003

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Government to loosen regulations on control of entry

Control of entry to pharmacy contracts in England is to be loosened, but retained, Trade and Industry Secretary Patricia Hewitt announced on 17 July.

Under proposals put forward as the Government's long-awaited "balanced package of measures", control of entry will be lifted from pharmacies in large shopping developments, from those open for more than 100 hours a week and from pharmacies in one-stop primary care centres. Internet and mail-order pharmacy will also be made easier to establish (see Panel below).

Proposed exceptions to control of entry

Under the Government's proposals, control of entry will be removed from:

• Pharmacies in large shopping developments (over 15,000 sq m gross floor space)

• Pharmacies that intend to open for more than 100 hours a week

• Consortia pharmacies in one-stop primary care centres

These pharmacies, however, will have a duty to provide a full and prescribed range of services laid down by the local primary care trust.

• Internet and mail-order pharmacies will be permitted in line with provisions in the Health and Social Care Act 2001, subject to services being agreed within the proposed national contractual framework

• Local pharmaceutical services contracts, which are not subject to control of entry, will no longer need PCTs to get approval from the Department of Health

However, the Government has rejected the Office of Fair Trading recommendation that control of entry should be abolished in its entirety. In a written statement Mrs Hewitt said: "We do not believe that simple deregulation is the best way to achieve our aims." She added that the Government "intends to move cautiously in the direction recommended by the OFT" but that "this is not the time to move to a fully deregulated system".

A shortage of pharmacists, which is expected to persist for some years, and plans to expand the role of pharmacists within the National Health Service were given as reasons as to why the time was not right for full deregulation.

The regulations governing control of entry will be modified incorporating new criteria for the "necessary or desirable" test. Primary care trusts will have an obligation "to promote consumer choice and harness the benefits of increased competition", Mrs Hewitt said. This will apply to applications for new pharmacies and to existing pharmacies that wish to extend service provision. Application and appeals processes are to be simplified. Secondary legislation to implement this is to be introduced in April 2004.

The Department of Health is to publish a consultation document by the end of August on how the proposals to modify control of entry should be implemented. This will be followed by a 12-week consultation process. In addition, an advisory group, with representatives from pharmacy, medicine, the National Health Service, patient, consumer and competition groups and persons with a track record on regulatory reform, is to be set up to advise on the details of the implementation.

The Government is promising to review the impact of any changes after three years, involving the OFT in the process, and to publish its findings.

The OFT recommendation for deregulation has previously been expressly rejected by the Scottish Executive and the Welsh Assembly Government.