Drug firms and ministers blame each other for not anticipating the spike in demand after a host of celebrity campaigns
The menopause is universal, but the shortage of HRT is a uniquely British problem.
Besins Healthcare, which makes Oestrogel, the HRT product with the most severe shortage, supplies 90 countries. Yet the company admitted: “Increased demand for Oestrogel has only been seen in the UK.”
Women across Britain are struggling to find oestrogen gel and other prescribed HRT products. Two thirds of pharmacies report daily shortages, and three quarters of pharmacy staff say they have experienced aggression from patients as a result. “HRT crisis ‘putting women’s lives in danger’ ”, one newspaper front page warned last week.
Faced with such headlines, and fearful of the fury of high-profile women, the government has leapt into action. On Thursday Sajid Javid, the health secretary, set up an HRT supply task force. On Friday he issued a “serious shortage protocol”, limiting prescriptions of the most popular products to three months’ supply per patient. Manufacturers, meanwhile, talk vaguely of increasing demand, the “ongoing challenges” of the Covid pandemic and “supply chain problems”.
But if this is an issue of supply and demand, of manufacturing and distribution, why does only Britain seem to be affected? After all, President Biden has not had to appoint an HRT tsar, and chemists in Paris and Madrid are not being threatened with violence.
In a sense Britain has become a victim of its own success. As the Labour MP Carolyn Harris, a long-standing campaigner on the menopause, put it: “We are ahead of the rest of the world on this issue. We have raised awareness among women in the UK, and demand has gone up. That is what is causing the shortage.”
Successive campaigns on better provision for menopausal women in the workplace and on prescription charges for medication [in England], as well as the national women’s health strategy, have raised the profile of the problem. The taboo is being broken down.
Women who might once have accepted an antidepressant are now going to their GP and saying, ‘I’m not depressed — I need HRT,’” Harris said. But she added: “This hasn’t happened overnight. The government has had time to plan for this.”
The popularity of hormone replacement therapy in this country has fluctuated over the years. When the treatment was introduced in the 1960s, it revolutionised the way women aged. By artificially replacing hormones as they were depleted, doctors found they could ease the worst symptoms of the menopause and reduce the risk of long-term diseases such as osteoporosis.
In the 1990s two studies in Britain and America started collecting data on whether HRT had side effects. The research, published in 2002 and 2003, found it increased the risk of cancer and heart problems.
Almost overnight usage of the drugs dropped to the floor and stayed there. Women and their doctors were terrified of the cancer risk. In 2000 GPs issued six million prescriptions for HRT; in 2017 they gave out only 2.5 million.
In recent years the pendulum has swung back in favour of HRT. Analysis of the studies that had scared women away revealed that the risk was not as great as had been thought. In 2015 Nice, the NHS medicines watchdog, told doctors that instead of warning women off the drugs, they should set out the risks in clear terms and allow them to form their own view.
For every 1,000 women who take combined oestrogen-progestogen HRT pills, doctors were told to inform their patients, eight women would develop breast cancer who would not have done otherwise. There was a risk, but it was a defined risk. And it was temporary: if treatment was limited to five years, the additional cancer risk would fall over the next five years until it returned to normal. Using topical treatments such as gels and creams, rather than pills, reduced the risks further.
Prescriptions at first began to creep back up. After high-profile campaigns by celebrities such as Davina McCall, Mariella Frostrup and Gabby Logan, who have spoken about their own experiences with the menopause and HRT, the popularity of the treatment has soared. The fear has gone, and the taboo is disappearing. In January this year 520,000 prescriptions were issued for HRT, a 50 per cent rise from the 345,000 given out a year earlier and more than double the 240,000 issued in January 2017.
Last year five million prescriptions were issued. HRT usage is nearly back to the level it was before the cancer scares of two decades ago.
But the recent spike in demand has not fallen evenly on the sector. Many treatments have had no increase, but certain gels, creams and other formulations have had a marked rise in demand. Oestrogel, Ovestin cream and a slow-release tablet called Premique are the most popular. Besins said in the past three months it had supplied twice as much Oestrogel to British wholesalers as in the same period last year.
Ross Maclagan, distribution and supply chain policy manager at the Association of the British Pharmaceutical Industry, stressed that dealing with such a spike in demand is not easy.
“If you are going to increase your supply by 10 to 20 per cent, that’s relatively easy,” he said. “You can probably do that within your normal rhythm of demand and supply, using your buffer stock levels and tweaking future orders. But if you’re going to increase your supply to a specific country twofold or threefold, then that requires a full plan: increased production runs, increased sourcing of active ingredients, more [packaging] cartons, more patient information leaflets and so on. Realistically it takes a year to 18 months to have a fundamental increase in supply of that level.
Campaigners insist the government should have foreseen the problem. McCall, speaking last week to promote her upcoming documentary Sex, Mind and the Menopause, said: “I mean, this idea of blaming women — ‘Oh, more women are asking for it’ — drives me absolutely mad. There’s been a gradual growth. You can easily plan production for that. HRT shortages are unacceptable.”
Manufacturers say government policy has not helped. Mark Samuels, chief executive of the British Generic Manufacturers Association, said a levy designed to limit the NHS drugs bill had hit HRT manufacturers hard. The charge, which is called the voluntary pricing access scheme (VPAS), increased in January from 5 per cent to 15 per cent of net sales. “It is extraordinary,” he said. “In December the government launched a strategy to increase the uptake of these medicines, and a month later it tripled the levy on them.
The VPAS applies to branded drugs only: most are still under patent, giving their manufacturers a monopoly and the freedom to charge what they like. Once a patent ends, the drug becomes generic and the price usually drops by 80 per cent to 90 per cent. But HRT is in a distinct category, branded generics, which means manufacturers are forced by market economics to charge a much lower price but are still subject to the levy — a double whammy.
“Generics manufacturing operates on razor-thin profit margins but at very high volumes,” Samuels said. With firms around the world facing huge squeezes thanks to soaring shipping costs, energy costs and manufacturing costs, the extra levy dents those fine margins and poses a huge disincentive. “Most companies are multinational,” he said. “Where supplies are tight, global headquarters of shareholder-owned businesses have no choice but to allocate the most stock in the countries where their margins are healthier.” He added: “In the UK we have a combination of rising costs and a broken pricing system.”
And women are bearing the brunt.