Controls on medicines — launching a new medicine < Influencers contents | Print this page Launching a new medicine Once a product licence is issued, a summary of product characteristics (SPC) is made available to prescribers. Thereafter, the price will be set, the marketing campaign begins and the product will be advertised and promoted by medical sales representatives in hospitals and general practice. Unlike the USA, the Medicines Act forbids direct advertising to patients. The marketing launch can be expensive but the Pharmaceutical Price Regulation Scheme (PPRS), which also controls the profits made on branded drugs, regulates what can be spent. NHS influencers might like to read Pharmaceutical Price Regulation Scheme: sixth report to Parliament. These reports are normally dry and boring. However from this report NHS influencers would draw useful background material on supply-side and demand-side pressures on the industry. Links are also made to the Pharmaceutical Industry Competitiveness Task Force (PICTF). The PICTF publications would also be useful for NHS influencers to examine. The DH launched an early consultation with the NHS on the next five-year PPRS scheme due to commence in October 2004. Please see the PPRS discussion paper, which basically suggests a limited number of future options — rolling forward the current scheme, a bit of deregulation or brand new ideas. Annex B contains the results of a study into the extent of competition in the supply of branded medicines to the NHS and suggests, amongst other things, that there is little evidence as yet that the demand-side initiatives that have been implemented have had much effect on prescribers on the relative prices of competing drugs. The executive summary of this is well worth the read. Note that amongst the stakeholder groups the government took soundings from before the renegotiations started formally were NHS management — particularly SHA, acute trust and PCT chief executives. In DH press release 2003/0320 we discover that 'PPRS limits the prices of branded prescription medicines to the NHS by regulating profits.' The last renegotiation led to a mandatory price cut and the same is expected this time around. Pharmaceutical companies are free to set their own prices on new drugs, which are often set high, not only in order to pay for further R&D but also because in effect, once set, prices are difficult to increase at all during the patent period. It is worth pointing out that the price of more than 60 per cent of all medicines is below the prescription charge. The Medicines Act provides for the control of misleading or untruthful promotion, making it unlawful to publish advertisements incompatible with the wording of the product licence. The Association of the British Pharmaceutical Industry has a voluntary code of practice for its members, governing the ethics and conduct in marketing. Breaches of the code are widely published. Medicine categories There are three legal categories of medicines, classified into:
A new chemical entity will initially almost certainly be given a POM license. As the patents on more branded medicines expire, more POMs are being reclassified to P and some of these to GSL. Note then that omeprazole (10mg tablets) has been reclassified to P (supplied under specific conditions), as has the cholesterol-lowering drug, zocor (simvastatin). Zovirax cold sore cream has been reclassified to GSL. These changes are significant as this relates to independent prescribing by nurses, who are able to prescribe all P and GSL medicines. But the reclassification of simvastatin has caused considerable debate. In a stinging editorial, The Lancet journal echoed the Consumers’ Association in saying that no trials of over the counter (OTC) simvastatin have been conducted, and added its concerns that individuals purchasing the statin must be encouraged to make important lifestyle changes, such as giving up smoking and losing weight. While the US knocked back two applications for OTC statins in 2000 because of insufficient evidence of their efficacy in this setting, The Lancet claims the UK — the first country to make a statin available OTC — will become ‘guinea-pigs in this large-scale OTC experiment.’ With 1.8m people prescribed statins in the UK, at a current cost to the NHS of £700m per year and expected to rise to £2bn by 2010, the journal says: ‘It is difficult to avoid concluding that the motive behind the government’s decision is saving money.’ The Lancet also believes the OTC move will increase health inequalities, with only the better off able to afford the anticipated £15 per month cost, and stresses that the UK must implement a surveillance system to evaluate the risk-to-benefit ratio of using statins in this setting. See www.thelancet.com and Wellard’s NHS news, May 2004. Patent expiries ‘Patent expiries — how should they affect prescribing advice?’ in October 2003’s Pharmaceutical Journal is a worthwhile read for all NHS influencers. It is a review on trends in the generic drugs market and how these should influence the policy decisions of primary care organisations (PCOs). The piece replays the fact that PCOs had looked forward to windfall savings when products came off patent but that there is increasing evidence that it is now taking much longer for the NHS price of generic drugs to fall by an amount significant enough to affect prescribing budgets. There is a useful discussion on branded and generic statins, generic omeprazole, formulary inclusion and switches and the fact that some PCOs have already built anticipated savings into their budget projections. 'Where this is the case, these PCOs are likely to be left facing a search for additional economies in order to deliver a balanced financial position as the year progresses,' the article says. Generic medicines The government has also introduced a brand new system of reimbursing the cost and supply of generic medicines. Four generic medicines (simvastatin, omeprazole, lisinopril and doxazosin) have seen their reimbursement prices reduced twice in 2004. The new scheme replaces the ‘maximum price scheme’, introduced in 2000 following concerns raised over costs and availability of generic medicines. For the latest consultation letter, please see the DH’s ongoing consultation section. Yellow Card scheme NHS influencers might like to know that the Medicines and Healthcare Products Regulatory Agency (MHRA) extended its suspected adverse drug reaction reporting scheme (the Yellow Card scheme) in 2003 to all nurses, adding around 330,000 NHS health professionals to the scheme. The scheme now accepts reports from doctors, dentists, pharmacists, nurses, midwives and health visitors. The extension is also being supported by the introduction of an electronic Yellow Card, which can be used by all health professionals to enable quicker and easier submission of reports. The e-Yellow Card can be found on the MHRA website. To strengthen the scheme still further the MHRA is working with NHS Direct to enable patients to report through NHS Direct telephone lines and to use NHS Direct Online. So patients who experience side effects from their medication can now report problems to medicines experts directly rather than having to see their GP. The intention is that the scheme will be rolled out across England. Patients suffering from adverse effects from a medicine will also for the first time be able to report them directly to the MHRA and the Committee on Safety of Medicines. Reporting cards will be placed in GP surgeries and ‘patients are not expected to use conventional scientific or medical language in their report’. Over the counter medicines The MHRA has also published plans to remove legal restrictions on advertising a range of over the counter (OTC) medicines. The vast majority of OTC products may already be advertised to the public. However, the current UK legislation lists a number of diseases for which this is not the case, although they can be purchased through pharmacies or more widely through retail outlets. The MHRA consultation sought views on the removal of these restrictions. Medicine advertising is already tightly controlled through voluntary codes of practice operated by the industry and advertising regulators. This is backed by statutory controls enforced by the MHRA. All these safeguards will remain, including the ban on direct to consumer advertising of prescription only medicines. The full proposals are available on the MHRA website.
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