A European Directive, the Food Supplements Directive, came into UK law on 1 August. Although there are exemptions until 2009, the Directive will introduce a huge regulatory burden on the selling of food supplements, and it is likely that many supplements will disappear off shelves. In practice this means:

The vitamin & mineral tablets used by millions of British people are under threat. Products such as 1gram Vitamin C tablets that are frequently used in the cold season, and the mineral Boron, important for strong bones and teeth, are set to become illegal once recently passed European laws are fully introduced.

Many more specialist vitamins that have been used safely by UK consumers for many years will also disappear. Almost every multi-vitamin tablet sold in Britain will have to be reformulated to avoid breaking the law.

So why is the EU doing this? In part it is caused by an over-zealous appreciation of regulation. But, there is another, more significant reason for this Directive: the lobbying by pharmaceutical companies. Diet supplements - as sold in health food stores like Holland & Barratt - are cheap and not covered by patents. By discouraging their use or getting them banned, Big Pharma is able to force consumers onto patented drugs, increasing their profits and tightening their pharmopoly.

“When you are in the health care business, when you create products as powerful and important as prescription medicines that can save lives and heal disease, you have a profound responsibility to gain and keep the trust of patients and health care professionals who rely on and use your products by being forthright and honest.”

- PhRMA president Billy Tauzin

The WTO is unlikely to get an agreement at all for two years, and to be honest most of the activities of people trying to make trade more pro-poor have been to do with agriculture. But TRIPS will resurface in the future. This is an article from Intellectual Property Watch:

Key officials in Geneva indicate that World Trade Organization members are not likely to find a compromise on a permanent amendment to global trade rules in order to allow poor countries to import affordable medicines in time for the December WTO ministerial in Hong Kong.

There is no formal deadline for items to be included in the Hong Kong agenda, but “in practical terms any text to be taken to Hong Kong should be completed by about 2 December at the latest,” a WTO official said. That is because the following week people will have started travelling, he said. The ministerial will be held from 13 to 18 December. The public health issue is not required to be part of Hong Kong agenda.

At issue is a mandate for members to make a permanent amendment to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to allow countries to import cheap generics under compulsory licenses when deemed necessary. Such a waiver was mandated to be made permanent by 2002 under paragraph six of the 2001 Doha Declaration on TRIPS and Public Health. A temporary waiver was agreed on 30 August, 2003.

TRIPS is opposed by the leading free-market economists. Dr Razeen Sally of the London School of Economics says in a report for the Cato Institute, under the heading "Alarming Trends in the WTO": "TRIPS takes WTO rules in a new direction - not further in the direction of market access, but elsewhere, towards a complex, regulation-heavy standards harmonization agenda..."

Similarly, Prof. Jagdish Bhagwati attacks TRIPs in his book In Defense of Globalization. He writes that: "The damage inflicted on the WTO system and on poor nations has been substantial." He attacks the "pseudo-intellectual justification" for them through the pretense that they were "trade-related". Moreover, he writes:

TRIPs... were like the introduction of cancer cells into a healthy body. For virtually the first time, the corporate lobbies in pharmaceuticals and software had distorted and deformed an important multilateral institution [the WTO], turning it from its trade mission and rationale and transforming it into a royalty collection agency.

The consequences have been momentous. Now every lobby in rich countries wants to push its own agenda, almost always trade-unrelated, into the WTO, following in the footsteps of the IPP [intellectual property protection] lobbies. This is true... of the AFL-CIO and the ICFTU (International Confederation of Free Trade Unions), which want labor standards to be included in the WTO in the form of the Social Clause, allowing trade sanctions to kick in if the included labor standards are not met. Their principal argument is that TRIPs were allowed for the benefit of capital, so the Social Clause must be allowed to do the same for labor; environmentalists want the same done for nature.

So while drug companies pretend to support free markets, the reality is that their lobbying is damaging the future ability to make free trade agreements.

Alfred Engelberg, a Florida-based IP lawyer, had a letter in the Financial Times yesterday questioning whether intellectual property protection for pharmaceutical companies had gone too far:

...Seemingly oblivious to a growing chorus of concern about imbalance, trade negotiators for the most developed nations, spurred on by a powerful group of multinational pharmaceutical, software and entertainment giants who see new profit opportunities in emerging markets, seek to impose even greater levels of intellectual property rights protection. In some cases, they are demanding that developing nations impose protection levels that go beyond existing law in their own country. They also seek global harmonisation of patent laws - not for the purpose of raising the quality of patents or the standards of patentability, but rather to make it easier and cheaper to obtain and enforce patents....

As was demonstrated by the Cipro shortage during the anthrax scare of 2001 and recently by the Tamiflu shortage, developed nations will not hesitate to throw their intellectual property regimes overboard to satisfy their national interests. Yet they do not seem to appreciate the burden that excessive intellectual property protections impose on developing nations with fragile economies and limited resources.

The time has come not only for a pause in the imposition of greater levels of intellectual property rights protection but, more importantly, for a careful re-examination of whether the existing rules regarding both the creation and enforcement of those rights are balanced in a manner that truly supports sustainable development.

An interesting article in the Financial Times last month suggested a way of stockpiling medicines for emergencies without excessive cost. James Love, director of the Consumer Project on Technology, suggests:

a better way of thinking about the management of emergency medical stockpiles - one that would change the incentives to protect us from anthrax, avian flu, severe acute respiratory syndrome and other emerging public health threats, at least for medicines that already have commercial markets for other uses.

The proposal is to permit governments to acquire medicines freely for stockpiles from generic suppliers, on the condition that if the medicines were used to treat people, the patent owner would receive royalties. This makes it much cheaper to acquire the stockpiles but also increases the value of the patented invention, as long as there is some probability that the emergency use will occur.

The Pharmaceutical Research and Manufacturers of America (PhRMA) offered cash to a book publisher to publish a book about "a dastardly group of Balkan terrorists [which] launches an attack on the United States by poisoning low-cost prescription drugs from Canada bought over the Internet by unsuspecting U.S. consumers."

The Toronto Globe and Mail says that:

According to one of the book's co-authors, Kenin Spivak, the goal was simply "to scare Americans into opposing any amendment to existing legislation" that formally bans the import of low-cost prescriptions from Canada. He said that the book's publisher, Phoenix Books, was paid an unspecified amount of money to publish the novel by the drug group, which also said it planned to buy 40,000 copies...

"Final approval of the book's content was with PhRMA. They would not have to publish the book if they didn't like it," Mr. Spivak said. Under the arrangement, the group's payments to the publisher were supposed to remain secret.

"As the project progressed, PhRMA's requests became increasingly odd," Mr. Spivak recalled. "They wanted the bad guys to be fundamentalist Muslims." So the terrorists, who were originally Croatian, were moved to neighbouring Bosnia and morphed into Muslims intent on poisoning Americans to punish their government for not supporting the Muslim cause in the Balkans.

The authors were also asked to simplify the story to make it more appealing to women, who are apparently major purchasers of drugs.

PhRMA initially claimed that the commission had been made by a "rogue employee", a "lower-level employee who acted without authority". It was later revealed that the said employee was Valerie Volpe, a very prominent spokesperson and the organisation's Deputy Vice President for Federal and State Affairs.

But it seems that the authors, fed up with dealing with PhRMA, are going to capitalise on the publicity anyway. The Karasik Conspiracy will now, says one of the authors, feature "a large company commissioning a real terrorist attack to scare Americans about Canadian drugs."

The book will be out early in 2006.

At a debate on intellectual property held in Westminster last week, Alan Story LLB LLM from Kent Law School launched a savaging attack on the way how pharmaceutical companies make monopoly profits at the expense of consumers. He said that it was ridiculous for pharmaceutical companies to claim their research is risky when they have consistently been the world's most profitable industry for three decades and that they make three to four times the profit levels of the Fortune 500 average.