With the European Commission soon to launch a review of EU pharmaceutical laws, the homeopathy industry feels the time is ripe to launch fresh lobbying push in Brussels to have the EU force all member states to provide access to the product from public health systems and loosen up the approval process for their remedies.
Representatives of the industry, practitioners and patients that use homeopathic products are to hold an EU Homeopathy Day in the European Parliament on 23 March as the kick-off for a new effort to win EU-level alternative-medicine-friendly legislation.
Industry lobbyists and their MEP allies believe that with the new European Commission expected to launch a review of EU pharmaceutical laws at some point during its four-year term, now is their chance to press their case.
"It provides an excellent opportunity for positive change," Irish liberal euro-deputy Marian Harkin, the organiser of the event in the parliament, told EUobserver. "The aim is to integrate homeopathy into EU health policy,"
Homeopathy claims to heal patients with highly diluted treatments of substances that cause physical responses that are similar to the symptoms of the ailment. Invented by German physician Samuel Hahnemann in 1796, the treatments are diluted to such a degree that nothing of the original substance is left. Its practitioners say however that the water retains a 'memory' of the substance.
While up to 125 million Europeans, including, famously, Prince Charles, use homeopathic products every year – the water is usually dropped onto sugar pills that are then consumed – and the industry was worth €1.05 billion as of 2009, reviews of all the published studies on the practice fail to demonstrate any efficacy beyond the placebo affect.
As a result, the practice is regularly pilloried by sceptics who attack it as pseudoscience and potentially dangerous if taken instead of conventional medicines such as vaccinations.
"There's always a question about the science," said Ms Harkin, "but with homeopathy, a lot of it is based on tradition and you need to be careful that the judgments are not purely based on science. They need to be based on efficacy as well as that."
According to Nand de Herdt, the president of the European Coalition on Homeopathic and Anthroposophic Medicinal Products (Echamp), the industry lobby group based in the European capital, said they are to press for "concrete action at the EU level," and that the coming legislative review "provides a very good opportunity to do so."
The European institutions, even after passage of the Lisbon Treaty, still have very little responsibility for the health sector and until now, the European Commission has said as a result, it has very little room to manoeuvre in this area.
But this time, according to Mr de Herdt, instead of trying the health legislation route, the lobbyists will "try to leverage single market rules," where the EU has very powerful powers indeed.
In this way, Echamp and its partners hope to win a harmonisation of laws governing the authorisation of homeopathic products across the bloc. "Some people have access to some products in some member states but not in others. Patients, doctors, practitioners are being denied access to the products they choose."
Ms Harkin believes the single market angle will work: "If we look at the EU and what it's basically about, it's about ensuring the free movement of people, goods and services across the union. So from that perspective, we can get legislation in this area."
Using the same legislative crowbar, the industry lobby along with the European Central Council of Homeopaths – the professional association for practitioners, the European Committee for Homeopathy – which brings together the doctors that prescribe the sugar pills, and the European Federation of Homeopathic Patients' Associations – representing the people that swallow them, hope to require public health systems to pay for access to such treatments wherever patients demand them.
"In most member states, homeopathy is a private matter. That is to say, not covered by all public health systems. But it ranges from country to country. This is a major concern. Sweden for example forbids doctors from prescribing it, while in France, it can only be prescribed by doctors."
Mr de Herdt complains that the number of homeopathic products on the market as compared to the total number of homeopathic products that could be available is far too low. They exist on the market, often sold by small outfits over the internet, but there is no legal status for these products. Unauthorised, they are tolerated by authorities.
"This is fine for a small internet business, but for serious manufacturers, this is not a good situation."
The problem is with the approving authorities, he says, "because they apply the rules that apply to chemical substances. But these are practices from a very old tradition, and authorities do not have the capacity to manage an appropriate assessment of these products."
As a result, the major push of the homeopathy lobby is to have a separate stand-alone EU directive that exempts them from regular chemical and other health and safety rules. EU legislation from 1992 lays down provisions for the licensing of homeopathic products, but Mr de Herdt says after 18 years, the laws are outdated, resulting in a "significant reduction in the number of homeopathic products on the market."
"The current system is substance-oriented. Our products need a system that is therapeutic-oriented," he said, explaining that it was not just the medicine itself but the whole process a practitioner applies that produces the result.
Echamp meets with commission representatives "three or four times a year" and Mr de Herdt says that the EU executive is on side with most of their arguments already, but that the changes they are looking for are for the moment "not at the top of their priorities."
"On the level of the therapeutic argument, research projects, we've had a lot of success, but in terms of product authorisation, the success so far has been more limited."
On 16 March, the new European Parliament Intergroup on Complimentary and Alternative Medicine is to have its founding meeting. The work programme of this initiative, an alliance of MEPs and "a consortium of European homeopathic patients and doctors," is to focus on "improving access, availability and choice."
Already, in 2006, the chamber amended the Seventh Community Framework Research Programme (FP7), the EU's main instrument for funding scientific research, to include 'complementary medicine' and in 2007, the parliament similarly amended the Second Programme of Community Action in the Field of Health, the bloc's funding mechanism for public-health-related projects.
Then in October 2009, the EU awarded a grant of €1.5 million for a 36-month research project carried out by the Communication Platform on topics related to Complementary and Alternative Medicine in Europe (CAMbrella), a Munich-based, 12-member-state research network whose advisory board includes alternative medicine practitioners and product manufacturers. The project's remit includes a review of the current legal status and policies governing alternative medicine provision in the EU.
UK parliament committee: 'Just a placebo'
The lobby's fresh push for EU homeopathy rules comes just as the UK readies itself to strip provision of homeopathic medicine from the country's National Health Service. On 22 February, the influential Scientific Committee of the House of Commons slammed the practice, saying there was no evidence that it provides anything more than the placebo effect and that manufacturers must stop making medical claims for their products.
Andy Lewis, the proprietor of the Quackometer website, which debunks quack medicine on the internet, said that the new campaign of European homeopathy lobby was at odds with the British parliament's enquiry.
"The MPs concluded, after a very detailed review of the evidence, that homeopathy was scientifically implausible and could not be shown to be effective," said Mr Lewis, who was also one of the organisers of a series of 'homeopathy overdose' demonstrations outside pharmacists across the UK in January in which sceptics swallowed entire bottles of homeopathy sugar pills. "The recommendation was that homeopathy should not be publicly funded and that medicines labeling regulations should not allow it to make unfounded claims."
"The EU would be failing its citizens, and pandering to business interests, if it allowed homeopathy sugar pill manufacturers to make misleading claims about this discredited 18th-century quackery," he added.
Ms Harkin, for her part, is familiar with such criticism, but dismisses it as in the service of Big Pharma: "There are those that believe that only those medicines prescribed by doctors and manufactured by Pfizer (PFE) will make you well, but a lot of ordinary people do not subscribe to that view."
"[The sceptics] are saying medicines must be judged by one criterion only, that it satisfies a scientific equation. Whereas there are many standards by which medicines should be judged," she said.
"The agenda is to say that science has the answer to everything. Well, they should have learnt by now that it hasn't."