The licensing of the fist oral therapy, the PDE5 inhibitor, sildenafil, in September 1998 enabled primary care physicians to initiate therapy without referral to specialists. These drugs work by inhibiting a chemical in the muscle of the penis, which allows the effect of the sexual stimulation to result in enhanced erection. It does not increase sex-drive. Recent research has shown that these drugs are safe and that restoring a normal sex life to men with cardiovascular risks reduces morbidity and mortality and long-term studies of PDE5 inhibitors suggest a similar benefit. Two new PDE5 inhibitors will be available shortly and one of these, Tadalafil, has duration of action of up to three days, which may allow for more spontaneity and cost effectiveness. A major advantage of these drugs is that the effect is obvious and frequently obvious early in therapy, unlike some drugs that are taken for many months with no clear evidence of efficacy. Seventy-five per cent of all primary care patients will respond to these drugs and the only justification for secondary referral would be a failure to respond, younger men or more complicated cases.

Men presenting with erectile disorders are usually showing signs of vascular disease in small vessels five to 10 years before coronary vessels are affected. ED is often the first presenting symptom of diabetes and is closely related to levels of LDL cholesterol. It is well known that men are reluctant to attend a GP for health checks and ED may represent an excellent opportunity for influencing men's health. This is an essential part of a general practitioner's work as he is managing the chronic conditions such as diabetes, hypertension, raised cholesterol and depression that are frequently associated with ED in particular and sexual problems in general. He usually has knowledge of the personality of the patient and his partner.

Schedule 11 was introduced amidst concern that demand for a new therapy affecting 10 per cent of all men would be unaffordable. These regulations restricted therapy to a few arbitrary conditions and excluded patients with vascular disease and depression. A novel concept of "severe distress", requiring a consultant diagnosis and long term hospital therapy was introduced and a recently published review suggests that schedule 11 interpretation in secondary care had lead to a four fold increase in secondary consultations despite falling levels of injections and surgery, formerly the main hospital activities. Hospitals have been expected to fund drugs by making cost savings in other areas. "Severely distressed" patients require indefinite follow up at the expense of more serious conditions. Many hospitals have abdicated responsibility leading to gross postcode inequalities, ranging from three years to see a specialist in Plymouth to four weeks in Sutton Coldfield.

In 2000, the NHS spent £20.4 million on the secondary care of ED and 40 per cent of consultations related to interpretation of Schedule 11, suggesting a potential saving of £8 million if the regulations were abolished. The drugs cost of managing ED in 2000 was £24 million, compared with £99 million for back pain, £160 million for female hormones and £441 million for statins to lower cholesterol. Dependent on the dose of medication, ED can be managed from between £160 and £240 per patient per annum (excluding recovery of prescription costs). At present, many elderly patients on low incomes are required to pay private charges of £9-10 per tablet, because their problem was caused by a heart attack, depression or blood pressure therapy.

A further consequence is that men with a medical condition that is a direct consequence of important medical conditions are being driven out of mainstream medicine to obtain medication from sources such as the internet or black market sources, confirming that a major health care opportunity for men has been sabotaged by these regulations.