A
compulsory language test taken by foreign doctors wanting to work in
The EU ban on most vitamins and minerals is also aimed to do most harm to Britain as we are the top vitamin-takers in Europe (Telegraph 4/7/03)
THE
powerful tumour-fighting drug, designed to combat prostate cancer, is regularly
prescribed by Dr Malcolm Donaldson at his clinic in
A
dangerous and disagreeable piece of legislation
comes before the House of Lords today . In order to implement the EU's directive
on higher-dose vitamin supplements, the Government proposes to
ban nearly 300 products currently on sale in our health stores. The
proscription of these vitamins is the first in a series of EU regulations
dealing with alternative remedies. A second directive, covering herbal
medicines, is already clanking its way through the machinery of state. There are
proposals to regulate homoeopathy, and even to require a standard European
qualification for herbalists (who, in
A
whole range of everyday products looks set to disappear from the shelves under
plans to control the marketing of biocidal products in the UK.
Products such as disinfectants, preservatives and pest controls could all be
withdrawn from sale in the next few years, limiting consumer choice and raising
public health concerns in the process. The Biocidal
Products Regulations implement an EU directive and form part of a
European-wide initiative to control the supply of chemicals. The aim is to
lessen the environmental impact of biocides and harmonise the market. This is to
be achieved by introducing risk assessments for all products, backed up by a
registration system. Any company wishing
to market a biocide has to notify the product under the regulations and provide
a full risk assessment before it can be registered for sale. Failure to
register will result in the product being withdrawn from the market. The
deadline for registration was initially May 2003 and, although this is now to be
extended until September 2003, time is still running short. The European
Chemicals Bureau has released figures which support earlier predictions that a
significant number of products will be withdrawn. The figures also throw up some
interesting anomalies. According to the latest information, biocides that have
not been notified and are therefore expected to be withdrawn, include cresylic
acid, which is used in disinfectants and solvents; pyridine, used in the
manufacture of drugs and vitamins; antibacterial agents, including
hexachlorophene and metronidazole; products for mosquito control; substances
used in perfume including geranium oil,
orange oil and linalool as well as caffeine, bitumen and lemon juice. .
Companies are playing a waiting game to see if others plan to register the same
product. This is understandable as the cost of carrying out a risk assessment can potentially run into millions of pounds.
The Health and Safety Executive (HSE) estimates that the overall cost of the
review procedure is between £62 million and £151 million. A further concern is
the public health issues associated with an unmanaged withdrawal of essential
products from the shelves. Despite consulting with the US Environment Protection
Agency, the HSE’s Regulatory Impact Assessment does not give detailed
consideration to the health and safety risks. Instead, it concentrates on the
benefits of controlling biocidal products. The costs involved in registering a
substance may also limit the development of new products. Members of the
biocides industry are already giving warning that excessive costs will inhibit
innovation. The aim may be laudable but the risk assessment for biocides is
going to be a mammoth exercise. It poses the question of whether the
environmental benefits of carrying out risk assessments on everyday products
such as coffee and lemon juice justify the costs to the
The
European Central Bank says that our
state-funded health care system is incompatible
with the stability and growth pact. (Daily Telegraph
The west country has a reputation of being the best givers of blood. Two volunteers have organised the sessions in Minehead for 22yrs, incl putting up posters, opening up centre and supervising the tea ladies plus other chores. Just before Xmas they received a curt letter from Birmingham telling them that their services were no longer required. the reason was that the NHS receives a confidential form from the donors and as they are not NHS paid employees they cannot organise. They would contravene the EU data protection regulations. At the next session it was chaos, the donors walked out; the tea ladies are so upset they won't help and local donors won't come any more . (IND-UK 16/1/03)
There has been a wave of protests over spending cuts implemented by the German government to adhere to the terms of the Stability and Growth Pact. Chemists in Germany have been hanging black shrouds in their windows to protest over cuts in the health budget, which they say will kill the industry and cost over 20,000 jobs. Doctors in Germany are also preparing to work to rule for one day a week in protest over the spending cuts. Only emergency services will be provided on this day and patients should expect much longer waiting times. The President of the Doctors' Association, Hans-Jurgen Thomas said, "we are sick to the back teeth of being the whipping boys of the nation" Meanwhile, a new survey by the Association of German hospitals (DKG) showed that 82 percent of hospitals are expecting to reduce their staff levels in 2003 due to government spending cuts. This will result in the loss of over 27,000 jobs. (Der Spiegel, 16 December).
Vitamin and herb ban: Without access to alternatives the whole European population will be forced to rely on prescription drugs. If that isn't a nightmare scenario I don't know what is. What I fail to understand is that when 'health' care costs are sending nations broke they are stopping citizens from looking after their own health. Classifying vitamins as medical drugs available only on prescription will not help people to accept responsibility for their own health at all. If you think this is all for your good, think again. It is all for the good of the dollar. Several of the European Commissioners involved in this legislation have direct links to major pharmaceutical companies. One of the Commissioners, from Holland, is a member of the supervisory board of one of the world's largest pharmaceutical companies, Merck, Sharp and Dohme. (Global Wellness Newsletter 13/11/02)
An Oireachtas (Irish parliament) committee has expressed concern that a European Union directive on the quality and safety of blood collection could leave Irish patients open to infection from imported blood, writes the Irish Times. Dr William Murphy, the director of the Irish Blood Transfusion Service, told the committee on European Affairs that there was no provision in the directive for a Commission-based authority to oversee how well each state implemented the standards, according to the Irish Times. The European Commission directive proposal aims to make it mandatory for each member state to set up a national authority to inspect the blood service and the new requirements. Furthermore, the aim is that once adopted, the directive would establish a minimum regulatory and administrative foundation for transfusion services and it will also facilitate the exchange of human blood and blood components within the European Union. A Fine Gael member of the Irish Parliament, Sean Barrett, said: "This is an extremely important issue. You do not get a second chance if something goes wrong with a blood transfusion. The next port of call is a coffin," he told the Irish Times. Mr Barett, is especially worried that, in light of the expansion of the European Union and the growth in free movement, areas such as the importation of blood are not sufficiently protected. (EUobserver.com 6.09.2001)
THE European Parliament voted yesterday for a clampdown on unfettered sales of vitamins and mineral supplements, defying a lobbying campaign by the health food industry. The parliament's computer system crashed under the strain of thousands of speed-dial emails, wildly claiming that the new directive would ban 300 popular supplements and drive British health stores out of business. In Strasbourg, Euro-MPs were accosted by activists handing out a propaganda video accusing five European commissioners of corruptly colluding with big pharmaceutical firms in an attempt to destroy the alternative network of homoeopathic and natural medicines. The new law will bring Britain into line with the rest of Europe over the next 10 years, requiring manufacturers of vitamins and minerals to carry out scientific tests proving that their products are safe. At the moment, any supplement can be sold in Britain unless it is shown to be harmful, a policy that reflects the legal tradition of English common law that allows people to do what they want unless specifically banned. By contrast, Europe's Napoleonic legal system starts from the premise that everything is banned until legally authorised. Only 50 or so vitamins and minerals are on the safe list in most EU countries, so rarer products such as Selenium compounds used to treat cancer can only be obtained through prescription drugs, generating a much higher profit for the big drug companies. Small companies producing many vitamins and minerals considered a life-saver by people with unusual ailments would have great trouble meeting the costs of full testing on each product. (Daily Telegraph 14/03/2002) See items below from 1996 - Ed
Vote against the anti-vitamin laws: http://www.vitamins-for-all.org/english/default_vote.html
Soil samples from 3,000 farms in England and Wales have shown almost all were low in selenium – down to 0.001 ppm compared to the ideal of 1.5ppm. There is no doubt that this has an impact on human health. Restricted selenium uptake via grass and arable forage inevitably result in restricted availability via milk and meat. There is a strong correlation between selenium deficiency and susceptibility to TB. UK herds with a high selenium uptake have demonstrated greater resistance to TB. Areas most prone to TB are those with the lowest soil selenium levels. As human intake has declined so the incidence of TB in humans has increased. (Farmers Guardian 8/3/02)
Members
of the European Parliament are being inundated with unsolicited emails as part
of a campaign to draw attention to a move by the European Union to outlaw
high-dose vitamins and minerals. Matthias Rath, a German-born physician and
expert on cardiovascular diseases, is leading the protest. The EU's plans to
outlaw high-dose vitamins and minerals stem from the findings of the Codex
Alimentarius Commission (CAC), which was set up in 1961 by the UN Food and
Agriculture Organisation (FAO). Dr Rath, though, believes that the CAC is geared
towards protecting the global pharmaceutical market, and this harms consumers.
Dr Rath insists that there is a connection between vitamin deficiency and heart
disease, and says that restricting the distribution of vitamins could put at
risk the lives of millions of people. "The EU directive threatens to affect
all our lives and it is vitally important that we do everything in our power to
oppose it," said Dr Rath. "The freedom to make decisions about our
health is in jeopardy and this is what we are fighting against. Vitamins are
a basic nutritional right and we must defend this right to ensure the health of
ours and future generations." The Commission's proposal for a directive
on vitamins and minerals in food supplements was submitted to the European
Parliament on 10 May 2000. The parliamentary report on the directive proposed 38
amendments, which the Commission has incorporated into its proposal. The
Commission now hopes that the directive will be adopted by the European
Parliament, but Dr Rath is determined to prevent it from becoming EU law. (EUobserver.com
23/11/01)
The EU Commission is
putting the final touches to a regulation to ensure better control and
information of patients having breast enlargement operations. The
regulations are aimed at ensuring that women, who wish to get cloisonné,
saltwater or soya-bean-olie in-operated, get appropriate information before
going ahead. Furthermore, the Commission aims to ensure that the surgeons are
father to all safety procedures. "All together we want more focus on
safety," said European civil servant Ingeborg Gaspard, according to the
Danish newspaper Berlingske Tidende. The Commission regulation is a result of
lobbying by British and Belgium female patient groups, who felt badly informed
before their breast enlargement operations, reports Berlingske Tidende. (EUobserver.com
16/11/01)
EU HEALTH POLICY from speech by Health Commissioner: "It is therefore crucial that in the area of health, which is close to the heart of our citizens, the Community plays its role to the full. Showing people that the Community is capable of contributing in concrete terms to their health and welfare, will also help to win their support for the European project as a whole. People are more likely to sign up fully to the European cause if they see that the Community is stepping in to protect their health in areas where national governments cannot do this on their own. This is why it is vital that the obligation in the Treaty to ensure a high level of health protection does not remain simply an abstract idea, but is translated into practical measures which will benefit our population. Turning this principle into concrete actions is therefore a key priority for the European Commission. The new public health action programme is the principal symbol of this new departure. This programme, which is currently being discussed by the European Parliament and the Council, focuses on three priority areas which were selected as the areas where investment in health at Community level would yield the highest added value. Work on these areas will be undertaken involving candidate countries as well as a number of further European partners so that the programme will cover an impressive geographical area in Europe. First, the programme is aimed at improving health information. Second, it focuses on health threats and on developing systems to react rapidly to respond to them. Finally, instead of targeting certain diseases and conditions, we will in future concentrate on tackling health determinants - the key factors which lie behind them. Work will focus not only on determinants related to lifestyles, such as tobacco and alcohol, but also on broad social, economic and environmental determinants. The idea behind this programme is to launch a number of sustainable systems and co-operation structures; These would inform and underpin policy development both at Community level and also in the Member States. The Commission has laid the groundwork for the Community approach in its new health strategy and its public health proposals. These proposals need to be implemented quickly and effectively, and that requires the Member States to respond to them in a constructive way, and to play a full part in designing and carrying out all the specific actions." (David BYRNE European Commissioner for Health and Consumer Protection 2001-05-18)
Simple over-the-counter drugs, such as headache tablets with codeine, packed in the luggage for a week's charter trip will involve law-abiding Danes in absurd bureaucracy from March 25th, when Denmark joins the Schengen Convention . According to Danish paper Politiken, the Schengen rules require travellers to apply to their doctor for a certificate, valid for 30 days, proving their right to carry certain drugs to other Schengen countries. This certificate must be approved by the National Board of health. "This is a completely outrageous bureaucracy, costing the patients about 300 kroner (approximately £25), when they apply for their ‘pill passport'. And each drug requires a certificate of its own. We doctors might sit down comfortably and let the money pour in; but it is not the kind of money we like to make. We have been set into the world in order to treat sick people and not to play EU bureaucrats," says Ole Eckhardt Poulsen, president of the certificate committee of the Danish Medical Association, to Danish paper Politiken. The Danish Ministry of Health was evidently taken aback when the news was published by Politiken on Friday. The Minister of Health, Arne Rolighed, has called the rule both "sensible" and "grotesque" and "too bureaucratic", according to various sources, and he says that he will work for a simplification of the rules by introducing a common Schengen list of drugs that require a certificate. There has always been a rule that the traveller should be able to prove that medicine in her luggage is for her own use, according to Jørgen Bartels Petersen, Chief of Section in the Ministry of Health, who also says that the problem is that the lists used by different countries do not comprise the same drugs, writes the website netdoktor.dk. The Chief of Section has also made some research on practise in other Schengen countries, resulting in the information that France with her 60 million inhabitants issues fewer than 500 certificates per annum. Ole Eckhardt Poulsen says that this seems to indicate that the French authorities do not take the rules very seriously, writes netdoktor.dk. The Danish politicians are in a dilemma, according to Radio Denmark. On one hand, they cannot tell the Danes just to forget about the letter of the law. On the other side, they are not interested in having half a million Danes pester their already overburdened general practitioners for one or more certificates, or "pill passports", as they have immediately been dubbed, every year. (EUobserver.com 12/3/01)
Vat to be charged on many services provided by doctors in the UK..See the article in the VAT section on VAT.
According to Danish daily Berlingske Tidende an EU report in 1997 stated that gelatine made from cattle could spread BSE, also known as mad cow disease. Despite this knowledge it is not until now that the EU Commission has come up with rules that could have prevented the further spread. Experts have warned the authorities about the risk, which has now lead to a ban on the use of bonemeal in gelatine if the meal originates from countries known to have a high amount of BSE-cases. However, the risk of BSE is still there and will be until the end of 2001, when the new EU-regulation comes into force. Gelatine made from cattle and swine is used in products like cosmetics, cakes and winegums. (EUobserver 10/1/00)
The European Parliament has voted to ban as a criminal offence embryo cloning that would produce 'spare parts'. The British Parliament will have a free vote and is expected to approve stem cell and therapeutic embryo cloning research. (FT 8/9/00)
An example is Addenbrookes Hospital in Cambridge. Here the Working Time Directive is causing financial chaos with bed shortages, longer waiting lists and cancelled operations. Our finances are being bled dry by al the new demands on us and, in the end, it is the patients who suffer most. We seem to spend most of our time looking after the bureaucrats, said one hospital source. The hospital is spending £629,000 this year on the Directive, employing extra staff some merely to keep the new records straight! The two key hospital workers, doctors and nurses, are not - yet - covered by the Directive and the costs therefore are all on administrative staff. All routine admissions have been cancelled and even spaces for emergencies cannot be guarranteed. The NHS Confederation says We've seen the biggest cash increase into the NHS for years but almost all of it is being used to fund the new measures. Hospitals all over the country are going into the red because of them {Mail 17/7/99}(FFP)
Tablets can no longer be sold/supplied on prescription in convenient bottles, but must be supplied in small packets containing usually 28 pills in blister pack strips complete with a lengthy leaflet in each box. Not only is 28 a daft figure for anyone needing 3 or 5 tablets a day, but the storage space needed for all this packaging is - in one case - 25 times as great! Then these strips are extremely difficult for arthritic hands to use and many of the pills, in any case, get broken and the powdered bits are lost (and the dose therefore reduced). All of this is due to EU legislation and it some cases it has put up the price which the NHS pays for the prescription by 800% - by 8 times!! That¹s where the extra money goes - your money! {Scottish Mail 24/9/99} (FFP Dec 99) A letter writer to the Times complained that he could not get a sling from his clinic because it was waiting for a new EU-approved surgical sling - from France {Times 28/10/99}(FFP Dec 99)
Ferries will no longer be able to take doctors to two Scottish highlands to deal with emergencies in the middle of the night because of European Union working time laws. Caledonian MacBrayne, the ferry company, has told residents on Ghiga and Iona off the west coast that working time legislation makes the emergency service impractical. If the ferry were called out in the middle of the night it would not be allowed to start its normal daily run until the middle of the following day. Both islands have populations of about 100 and no resident doctor. (Financial Times 16 February 1999)
Under EU regulations the UK is obliged to import drugs which are claimed to be of equivalent potency to UK approved types. There are significant quantities of counterfeit and useless drugs on the market but the Medicine Control Agency does not have adequate resources to detect them. (BBC R4 Face the Facts 25/8/98)
In theory any doctor could work in a member state. But in Italy it argued that because doctors issue official certificates they were exercising public power. Positions of public power can be legally exempted from the requirements that jobs be open to all EU citizens. The Commission rejects this argument. (European 6/4/98)
The EU has introduced new rules relating to by-products from cows. Nothing can be used unless the at-risk offals are removed. This includes tallow that is used in many different products such as 80% of pharmaceuticals, as well as cosmetics, lubricants, soap, tyres, packaging, paints, plastics and printing ink. The US has complained that the tallow ban will hit $100m worth of exports to the EU, Canada and New Zealand will also be affected. Commissioners persuaded 8 out of 15 Farm Ministers to agree the ban. This was not a qualified majority but under arcane EU rules on health issues it was enough to allow Brussels to impose the ban. (FT 6/8/97). Up to 80% of pharmaceutical products also contain gelatine derived from animal carcasses. (FT 9/9/97) EU vets decided they couldn't guarantee that cattle in the USA are BSE free even though there has never been a case (the problem of proving a negative). This makes it impossible for the EU to exempt products made from cattle parts from the ban in January 1998. (FT 19/9/97).
The EU is to ban the sale of most vitamin pills on the British market. The French and Germans restrict the sale of vitamin supplements to the recommended daily allowances, usually trace amounts. This is the to be the EU standard. The UK limits doses to the maximum safe amounts. No currently available vitamin C pills will be allowed. The effect will be to divert sales to mail order from the USA which has the same controls as the UK. (BBC R4 Europe Now 5/10/97) ABOUT TURN! Commissioner Bangeman has proposed to deregulate laws restricting the sale of vitamin and mineral food products to pharmacies. Experts should reach a decision on setting maximum safe consumption levels. This would put the Commission on a collision course with Germany and France where maximum levels are based on minimum levels needed to satisfy basic nutritional requirements. They also only allow many food supplements to by sold in pharmacies under medical supervision. A previous attempt at liberalisation failed in 1992. (European Voice 8/10/98)
The EEC is to regulate food supplements such as vitamin pills (CEC). The CEC says that there is simply a discussion paper on the subject. This has now become a firm proposal. All vitamin and mineral supplements will be subject to expensive certification and testing procedures. These tests are so expensive that very few manufacturers will be able to implement them, thousands of products will be removed from sale. An organisation called Consumers for Health Choice has been formed to fight the draconian EU regulations on behalf of the 7 million people who use such supplements (BBC R 4 19/9/96).
Phenylbutazone, or bute, was the first really effective painkiller for lame horses and has enabled thousands of them to lead normal active lives. It will be banned in the EU in January 1998. The reason is that in Europe horses are used as meat and humans might receive a dose. No figures exist about how much horsemeat has to be eaten for this to be harmful. The welfare implications of losing the most commonly used painkiller in the horse are enormous. Without it many horses will have to be put down, many will suffer needlessly. The EU has not accepted the UK's exemption from treating the horse as a food animal. (Horse & Hound 14/8/97). Bute has now been granted a temporary exemption.
Chemists dispense NHS prescriptions in packs of 28 but the EU has laid down that the manufacturers must sell them in packs of 30. So all the time the chemists are having to snip a couple off each pack. (Chemist 11/8/97) Next time a politician tells you that more is being spent on the Health Service ask him or her how much more the NHS is paying for drugs as a result of the EU. It is the EU that has forced us to take supplies in strips with each pill separate. Previously they were supplied in bulk to the chemist who transferred the correct quantity to cheap plastic bottles. What has happened to the price? Well look at two standard prescription drugs, Warfarin and penicillin. Three months ago the Warfarin cost £20 a thousand; this is now £61 = +205%; the penicillin has jumped from £8 to £44 a rise of 450%. In the same way a bottle of 100 junior aspirins was 95p; now a strip pack of 28 is 85p over the counter - another massive rise, this time of 219.5%. (FFP 16/9/00)
The EEC is to ban the import of factor 8 used to cure haemophiliacs of their bleeding. The UK has to import some from the USA to augment our own production. Not only have we insufficient for ourselves but we will be required to supply Greece, Portugal and Spain as well. This attempt to impose self-sufficiency will be disastrous for our own patients. (Independent 3/5/93)
An EU ruling on part-time GPs will force hundreds, mainly women, out of their jobs. They are now required to hold Vocational Training Certificates and many do not. (Times 19/9/94) They can continue to work if the government re-categorises them (CEC Sept 95).
Forty years ago, Richard Doll looked up the records of all women who had claimed sick leave from chicken pox, measles or rubella and who then took maternity leave less than a year later. He confirmed that rubella was causing brain damage and blindness in the babies. That led directly to a vaccination programme. Who was hurt by that research? Nobody. But it would be illegal nowadays, because it used records for a purpose they weren't collected for. (New Scientist interview with Richard Peto p 47, 1/9/01)
A draft directive on privacy will have the effect of making epidemiological
research illegal. Article 6 says that NHS data must be destroyed after a
person has died, Article 7 that researchers must go back to the subject for
consent, Article 8 states that data holders cannot process data concerning
health or sexual life. This is the practice in France where it is illegal for a
doctor to pass medical data to another doctor not involved in treatment. In
Germany cancer registries have to get consent. The Director of the Cancer
Research Campaign says epidemiological studies have told us everything we know
about cancer and the environment. The Director of the Thames Cancer Registry
says the directive will make their work illegal (New Scientist 11/12/93). 
Information
obtained by Channel 4 News, shows that UK experts have been forced to pull
out of leading breast cancer research because of a combination of the
Data Protection Act and the Human Rights Act, and accentuated by the furore
surrounding organ retention. Even if a tissue sample is 20-years old,
researchers need new permission. They simply to not have the resources for that.
Channel Four News has learned that at least three pieces of vital cancer
research have been affected. The first a breast cancer study to discover how
aggressive a tumour is likely to become. One thousand tissue samples were
needed. But permission was refused so the pharmaceutical company, Roche has
withdrawn support (denied by the company). Research will now be conducted in
Europe. A second breast cancer study - to determine if the patient will
respond to hormonal treatment. Six-hundred-and-forty tissue samples are needed.
The biomedical company Celera Genomics is expected to pull out. And a
third study for prostate cancer. Already 150 people have been tested. But
permission has been refused by regional research ethics committee to extend the
study nationally. The implications according to Professor Foster on for instance
the breast cancer study moving to Europe are enormous. And the effects are being
felt across the country. It is now known for instance that hospitals are
withholding information from cancer registers for fear of breaching
confidentiality. Yet these registers are vital if these major killers are to be
tracked. (Channel 4 News May 21, 2001)
French pharmacists are pressing the EU to ban the sale of herbal and homeopathic remedies from health food shops, etc. unless a qualified pharmacist is present. In the mean time shop owners have to comply with a raft of regulations. For example it is a criminal offence to display camomile tea next to a licensed remedy containing camomile.
In January 1995 the European Medicines Evaluation Agency was established. This will sweep away all exemptions to the licensing requirements relating to herbal remedies supplied by herbalists and health food shops. Hundreds of products previously available will be withdrawn depriving thousands of patients from relief from chronic diseases. The Department of Health will lay new legislation before Parliament but under the EU regulations no debate is required and all statutory obligations to consult interested parties have been removed. The cost of licensing herbal products is high and there is no patent protection for licensees. Far from introducing these EU rules, in Germany the government has passed laws protecting their herbal industry from EU Directives. (Press release from BHMA October 1994). The government has decided to save this £300m industry employing 3,000 people by using the subterfuge that herbal medicines are not "industrially produced", an escape clause in the EU Directive (FT 31/11/94).
Melatonin is a dietary supplement that has been sold without any problems for years. It is a harmless natural substance found in porridge, tomatoes, and many other foods. The police in Sheffield looking for the so-called unlicensed medicine raided a health food shop. EU directive 65/65 says that anything that can be used for restoring, correcting or modifying physiological function in human beings must be regarded as a medical product. This definition can include a glass of water as a medicine. Melatonin has been removed from all health shops. The main UK supplier, Pharm Nord, which sold £1m a year has had £10,000 of stock confiscated. (Eurofacts 11/10/96). As a natural product melatonin cannot be patented but two major chemical companies are to sell a synthetic version which will be licensed. Under the EU regulations competition from the much cheaper natural product is outlawed. (S Telegraph p16 27/7/97)
Around 120 equine medicines to be withdrawn from the market because they are not licensed for residues occurring in meat for human consumption. Testing for Maximum Residue Levels, MRLs, is very expensive and unnecessary for horses which are not eaten in the UK (Horse & Hound 18/11/93). An exception may be made for the UK if a declaration is made that the horse is not for eating (BBC 1 Country File). However, a medicine licensed for a food-producing animal must not be used on a non-food producing animal, so horse medicines may not be used on farm animals any more (Vet bulletin for farmers Jan 1995) The British Equine Veterinary Association says that after the year 2000 the majority of medicines used to treat illnesses such as colic, or to anaesthetise a horse, will no longer be legally available. There are no alternatives. This is the single most important issue threatening the future welfare of horses and ponies in the UK. Certain pain relieving drugs, as well as anaesthetics, intravenous fluids, antibiotics and local anaesthetic, had no MRL and, therefore, potentially no marketing authorisation.(Horse & Hound 2/4/98)
In order to enable a vet to prescribe or dispense medicines for farm stock a vet has to prove that the animals are "under his care". This means that the vet must visit the farm every six months to ensure they have a working knowledge of the stock management system. (My vet charges £14 per visit). Urgently needed medicines can no longer be left outside the surgery outside regular opening times. It will be necessary to make a charge to meet the farmer when these emergencies occur. It is now against the law to dispense small quantities of injectables in a syringe. Neither can a vet accept back a virtually full medicine container used to dispense a single dose on the farm. A container can contain up to 50 doses. (Vet bulletin for farmers Jan 1995).
There is no longer an anaesthetic approved for use on cattle. The only one that can be used is approved for horses but this can only be used if the horse is classed as a farm animal. Cross species administration of medicines means the minimum withdrawal period is one month. This means that cattle cannot be killed for human consumption if it had an anaesthetic a month before.
Over 1,700 animal medicines have been withdrawn from the UK authorised list of 2,727 following the EEC Directive 81/851. This requires that all established medicines must be re-licensed at a cost of £15,700 per medicine and after 1998 the cost will rise to £78,800. Those that have been withdrawn are in the public domain so may be copied once someone has borne the cost of testing. Some are valuable products, such as the only vaccine against myxomatosis, but have little use so it is uneconomic to test them. (S Telegraph 4/7/93). Not only are prescription medicines covered by these rules but also flea powders, vitamins and rehydration products are also to be restricted (Vet bulletin for farmers Jan 1995). The result of the EU rules has been a massive increase in vet's bills to pet owners. Regulations intended to prevent drug residues in meat also apply to pets such as cats and dogs. Vets cannot use cheaper generic medicines on them any more as they are not economical to license. These rules are a heavy burden on animal charities which also have to buy expensive branded medicines some of which are not so efficacious (BBC R4 You & Yours 27/7/95). The UK government may defy this regulation to protect a poultry vaccine from withdrawal (BBC R4 Farming Programme).
All animal medicines currently sold by specialist merchants and agricultural suppliers will only be sold by vets. 1000 businesses to go. This directive has been referred to a working party. Tack shops will be forbidden to sell fly repellent (Horse & Hound 18/11/93).
Orfoids were a popular traditional remedy for orf, a disease in sheep. Now they are sold as Ovaloids and it is forbidden to mention what they are for. The packaging says "they are useful for the well-being of sheep". Sales of this product have consequently fallen. The supplier of this product Battle, Hayward and Bower Ltd. has suffered severely from the EEC directives 81/851 and 81/852, which require evidence that products are efficacious. This is extremely expensive to prove with herbal based products like Orfoids, the company lost its licence. Battle, Hayward and Bower mention that they had to remove lindane from their sheep dip although in France it is still used. Neither Ireland nor Italy have started to implement 81/851 and 81/852 while the UK has finished the re-licensing operation (Battle Hayward & Bower, Lincoln 23/5/94). Another company selling a remedy for orf is D Brincombe of Crediton. Its product is Tub-Orf and this highly regarded medication was also banned by the Veterinary Medicines Directorate. It is now called Frobut, Tub-Orf backwards, but again no claim can be made for its actual role. Another example of pointless bureaucratic intervention attempting to shut down a valued business (PE 8/3/96)
Aspirin, bicarbonate of soda and liquid paraffin will be withdrawn from use by vets because they have not been subject to the expensive licensing and testing procedure. This regulation derives from EC Directive 90/676 covering remedies for human use used on animals. Contravention leads to a fine of £5,000. (S Telegraph 19/6/94).
The European Directive on Medicines leaves no discretion to member countries deciding whether to suspend or withdraw a particular product (Financial Times 14/12/93).
Somatosalm is an important new drug that reduces mortality when salmon move from fresh to salt water. It has been developed using an EU grant by a new Belgian company, Pharos. They applied to the EU for registration over 18 months ago. The response has been that they object to the name, it sounds too much like Bovine Somatotrophin. BST has been banned but because Somatosalm leaves no harmful residues it implies that BST does not either. This is the only reason, there is no scientific evidence for refusing registration. (FT 8/2/96 and New Scientist)
Britain and Denmark have highly developed methods of pain control for cancer victims, many of whom die in excruciating agony. Other EU countries are influenced by religious sentiments about martyrdom, religious redemption and addiction. These countries put high barriers against the use of morphine. For example in Germany only 2% of terminally ill cancer patients receive morphine whereas WHO guidelines say 98% should have done so. A Euro-working party in the Netherlands is holding talks about harmonising prescribing policy and it is likely that dying cancer patients will be the unwitting victims of a Euro-consensus. (New Scientist 6/4/96).
Resistance to antibiotics is a growing hazard. MSRA is a virulent bacteria sweeping across hospitals which can only be killed by vancomycin. A similar drug is used on farms and vancomycin resistant bacteria have been found in farm animals. If this resistance is transferred to MSRA then the results would be fatal for humans who caught the infection. The German and Danish governments have banned the use of the drug on animals. The EU has ruled their action illegal on the grounds that it is an unfair barrier to trade (New Scientist 27/7/96)
The EU Commission has told the Swedes to lift a ban on antibiotics in pig feed. Although Swedish pig farmers have been able to raise pigs without a constant diet of antibiotics the EU says their law is an infringement of free trade. (BBC1 Country File 9/2/97)
Directive 92/27 on labelling of medicinal products proposes that the term mouthwash become illegal, and must be replaced by oromucosal solution. An enema must be described as a rectal solution. Other words to be banned include: mixture, lotion, application and elixir. Gargle is to be allowed. If these rules are approved by Brussels than they will be implemented through Statutory Instruments without Parliament ever seeing them. (Sunday telegraph 26/1/97)
The EU has decreed that 150 widely-prescribed drugs be renamed. Adrenaline becomes epinephrine, benzhexol becomes trihexyphenidyl, indomethacin becomes indometacin, lignocaine becomes lidocaine and nicoumalone becomes acenocoumarol. Several of these drugs are used in an emergency and doctors unfamiliar with the new terms could put patient's lives at risk. (D Telegraph 31/3/97)
Directives 93/16/EEC and 96/335 amend the Cosmetic Product (Safety) Regulations This requires virtually every manufactured cosmetic product to be re-labelled. We use the internationally recognised terminology originating in the USA. In order to ensure consumers anywhere in the EU understand the ingredients they must be described in Latinate terms. In order to translate Anglo-Saxon terms into Latinate terms it is necessary to purchase the 684-page EU directory and a chemical commercial dictionary costing £500. Water becomes aqua, lemon extract becomes citrus lemonium, soapwort becomes saponara officinalis. Rose Essence, an essential oil, has the same term as aqueous rose water. Every product must now have a safety assessment dossier, costing £600 a time. Many small volume products will be dropped because they will be uneconomical to process. A general medical practitioner must sign off the safety assessment. Previously acceptable qualified chemists under the UK Medicines Act 1958 are no longer legalised to approve such documents . GPs will have little knowledge of cosmetic production. (Eurofacts 11/4/97).