Wednesday, May 04, 2011

Alternative Medicine: Traditional Herbal Medicinal Products Must Be Registered for Safety and Efficacy in the European Union Starting May 1, 2011

After a seven-year transition period which started in 2004, alternative, herbal, Ayurvedic, Chinese, African, etc. medicines must be registered in the European Union for safety and efficacy as of May 1, 2011, or they may not be sold as "medicines".

The EU Directive on Traditional Herbal Medicinal Products does not prohibit the sale of traditional herbs or plants but they can not be sold as "medicines" without registration, which requires proof of safety and efficacy.

The EUROPA Press Release of April 29, 2011 by the European Union provides as follows:
"Traditional herbal medicines: more safety for products put on EU market

From tomorrow, EU citizens can be reassured that the traditional herbal medicines they buy in the EU are safe and effective. The expiry of the 7 year transition period set out in the 2004 Herbal Directive (2004/24/EC) means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011. The Herbal Directive introduces a simpler registration procedure than for other medicinal products, in respect of the long history of use of traditional herbal medicinal products. At the same time, the Directive provides the necessary guarantees of their quality, safety and efficacy.

John Dalli, European Commissioner for Health and Consumer Policy, said, "We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy. Patients can now be confident about the traditional herbal medicinal products they buy in the EU."

Simplified procedure

In order to protect public health, all medicinal products, including traditional herbal medicinal products, need a marketing authorisation to be placed on the EU market. The simplified procedure introduced by the Herbal Directive allows these products to be registered without the safety tests and clinical trials that a full marketing authorisation procedure would involve.

Instead, an applicant who wishes to register a traditional herbal medicinal product must provide documentation showing that the product in question is not harmful in the specified conditions of use. They must also provide evidence that the product has a proven track record, ie. that it has been used safely for at least 30 years – 15 of these in the EU.

Seven years to register

The Herbal Directive was adopted by the European Parliament and the Council on 31 March 2004. It gave an exceptionally long transition period of 7 years for manufacturers to register their traditional herbal products already on the EU market when the Directive entered into force.

Applicants have had 7 years to apply to the competent authority in the Member States(s) where they wanted to market their product. If, by 30 April 2011, a herbal medicinal product is not registered or authorised, then it may not be on the EU market after 1 May 2011. After this date, producers of traditional herbal medicines can still apply for a registration through the simplified registration procedure.

The Herbals Directive:

  • Does not ban traditional medicines from the European market. On the contrary, it introduces a lighter, simpler and less costly registration procedure than for other medicinal products. Plus it has given producers of traditional herbal medicinal products an exceptionally long transition period of 7 years to register their products.

  • Does not ban vitamins, mineral supplements and herbal teas.

  • Does not ban alternative therapies and therapists, homeopathy, plants or books on plants.

Background

Some plants contain substances that may be used to treat diseases. Medicinal products that are made from these substances are known as "Herbal Medicinal Products". Even though they are natural, a number of these products may be harmful to health. Therefore, these products are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products.

"Traditional" herbal medicinal products are a sub group of herbal medicinal products that have been in use for at least 30 years, including at least 15 years in the EU, and that are intended to be used without the supervision of a medical practitioner and are not administered by injection. This category is not limited to European traditional herbal medicinal products; it can also include Chinese and Ayurdevic medicinal products.

The Herbals Directive updated the 2001 Directive on the Community code for medicinal products for human use (Directive 2001/83/EC) by introducing a simplified procedure specifically for traditional herbal medicinal products.

Link to MEMO/11/71

Further information:

http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

"

Law and History: The Essence is the Same: Jonathan Sumption, Appointed to the Supreme Court of the United Kingdom

The LawPundit writes about the history of civilization and is gratified to have found an allied voice in the sometimes vast wasteland of scholarship:

The essence of law is to strip away the vast proportion of facts and what you’re left with usually supplies the answer. History is exactly the same.

- Jonathan Sumption (just appointed to the Supreme Court of the United Kingdom, author of a "narrative history of the hundred years’ war, so far numbering three volumes, [which] has been praised as “a masterpiece” by Frederic Raphael and “an enterprise on a truly Victorian scale” by Allan Massie")

This gift of reducing things to their essence is sometimes not shared by people in the humanities, linguistics, archaeology, anthropology and related historical professions such as Egyptology, Assyriology and Biblical scholarship and is one reason why those fields are marked in part by existing colossal mainstream errors that still need to be corrected down the road.

Conveyancing Quality Scheme (CQS) for Home-Buying in England and Wales via The Law Society

The Law Society, which represents solicitors in England and Wales, reports on its Conveyancing Quality Scheme (CQS), a home-buying quality standard, in Legal Ombudsman gives backing to Law Society's new home-buying quality mark, writing that it has thus far accredited 90 firms.

Privacy Law and Injunctions in the UK

See Inforrm's Blog for the UK status of privacy law and injunctions as of May 2, 2011 at Law and Media Round Up

Case Law Round Up of Freedom of Expression and Media Law in the USA at Inforrm's Blog as of April 30, 2011

Check out this useful April 30, 2011 posting on US Freedom of Expression and Media Law Round Up at Inforrm's Blog.

New Supreme Court Justices Appointed in the United Kingdom (UK) including the First Appointment Directly From the Bar, a Barrister


Image linked from BBC News

Are you up-to-date on The Supreme Court and the United Kingdom's legal system?

Did you know that Her Majesty The Queen signed a warranty granting "Courtesy titles for Justices of the Supreme Court" of the United Kingdom so that all Justices are addressed in a similar manner as "Lord" or "Lady"? The non-peerage title is good for life and the spouse of a "Lord" is also to be called "Lady".

There is a changing of the guard in process at the Supreme Court of the United Kingdom. Just last month Sir John Dyson, now Lord Dyson, was sworn in as the UK's 12th Justice to fill a post vacant since the Court started its work in October, 2009. Afua Hirsch has the story and we link to a photograph of the current Court via Akira Suemori of the AP at the Guardian.co.uk website (the Supreme Court website has the same photo):



Is Dyson (back left) that tall or did they just put the other tall guys on the chairs? Check out the article.

This month, as reported in the Guardian by Owen Bowcott, two new Supreme court judges have been appointed to replace retiring Lord Saville and imminently retiring Lord Collins, Lawrence Antony Collins, Baron Collins of Mapesbury, PC, who in his younger days received an LL.M from Columbia Law School in New York.

One appointee is Lord Justice Wilson of the Court of Appeal for England and Wales and the other is Sir Jonathan Sumption OBE QC, soon to be a non-peerage "Lord", "the cleverest man in Britain, with “a brain the size of the planet” and fees to match", a lawyer whose salary of £206,857 at the Supreme Court will be considerably less than the £1 million plus he reportedly earns annually in representing the likes of Russian self-made billionaire Roman Abramovich, now owner, among other things, of the Chelsea football club.

The appointment of Sumption is being touted as bit of a sensation in the UK as it is the first time a barrister has ever been appointed directly from the Bar to the Supreme Court of the United Kingdom, although other judicial appointments from the Bar have been made in the past.

Patent Suits as A Lethal Instrument to Eliminate Competition

Mike Masnick at Techdirt explains How One Startup Used Patents To Kill A (Better) Competitor and how patent holders "are using patents not to innovate, but to block and kill other companies...."

Not Over: Winklevoss Facebook Appeal and Civil Code Section 1542 Waiver of Claims in Settlements

Not Over.

As Yogi Berra stated and of which Judge Alex Kozinski should take judicial notice: "It ain't over 'til its over".

Bill at OC Metro Blogs discusses the Winklevoss Facebook Appeal at No Cooling Off Period for Settlement Agreements | OC Metro Blogs as involving California Civil Code Section 1542 waiver of claims in settlements. Civil Code 1542 provides:
"A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor."
The Winklevoss twins have filed a rehearing en banc from an appellate decision against the Winklevosses by the 9th Circuit Court of Appeals in which Chief Judge Alex Kozinski does not cut a very good figure in his awkward opinion for the court, talking about how good the lawyers of the twins were, that they had an opportunity for discovery (since when does that exculpate fraud?), what an expert professional their father was, how much Facebook has grown in value since the original settlement, and that one should now let sleeping dogs lie.

ALL IRRELEVANT. The statute does not write "should have been known" but rather writes "does not know or suspect to exist".

California Civil Code does not contain anything about the matters discussed by Kozinski in his opinion as being material to the LAW and Judge Kozinski and his brethren should learn to interpret statutes as they are written.

Section 1542 says explicitly that the general release (waiver of claims) is void if there are claims that a party does not know or suspect to exist in its favor, which would have materially affected the settlement. The language of the statue is quite clear.

The Winklevosses are claiming that material information about Facebook valuation was intentionally kept from them by Facebook during the settlement process. Since VALUATION is the central element in a settlement of this kind, "undisclosed material information" obviously fits the statute as bearing on claims that a party DOES NOT KNOW or SUSPECT TO EXIST in its favor, which would have changed the settlement, the major portion of which was corporate stock, whose VALUE determined how many shares the settlement encompassed. Facebook obviously had an interest to inflate its actual stock value in order to settle for a corresponding stock amount that actually was worth less than a true valuation of the company would have indicated. That at least is the legal position of the Winklevoss appeal.

A case of this kind demonstrates why the 9th Circuit is the Circuit most reversed by the U.S. Supreme Court because they apparently have trouble sticking to the language of the statutes.

Whether one now favors or likes any of the parties, whether they were represented by demigods or not, and regardless of the professions of their fathers or the fact that they were able to exercise discovery, the fact is that if one party wilfully fails to disclose information material to the settlement then a waiver of claims is void.

Whether or not the Winklevosses would actually get MORE stock or possibly even LESS in a new settlement or legal proceeding, given the sykrocketing market value of Facebook, is also irrelevent to this court case. If the Winklevosses want to take that risk, it is their right, win or lose.

But you can not, as a Court, put a stamp of approval on fraudulent settlement behavior.

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