The World of New York Wines : Is Winemaking "Agriculture" as a Matter of Law? What is Legal Zoning with respect to the Wine Industry?

Uncork New York! is the website of the New York Wine & Grape Foundation, headquartered in Canandaigua, New York State, USA. If you think you know the wine world, but are not familiar with New York State wines or wineries, you are in for a surprise.

In a region sometimes known better for its severe winter snow blizzards, New York State is home to the largest wine producer in the world, Constellation Brands, headquartered in the Finger Lakes District at Victor, New York, about 10 miles northwest of Canandaigua, the town (and lake) which in the year 1945 gave the company its original corporate name, Canandaigua Industries Company.


Its current name, Constellation Brands (NYSE: STZ, STZ.B), was a renaming from the later names Canandaigua Wine Company and Canandaigua Brands. At the Constellation Brands website we can read:

Constellation is the largest wine company in the world; the largest multi-category supplier of beverage alcohol in the United States; a leading producer and exporter of wine from Australia, New Zealand and Canada; and both a major producer and independent drinks wholesaler in the United Kingdom.

Constellation began business as Canandaigua Industries Co. in the year 1945 by selling bulk wine in barrels to bottlers in the Eastern United States. 60 years later, in 2004, Constellation Brands bought the famous California winemaker Robert Mondavi Corp. for $1 billion – in cash.

The bulk wine origin of Constellation Brands in the Finger Lakes District was possible because the area was favorable for winegrowing and a lot of grapes were grown there (including also many of the grapes used in the famous Welch’s brands of grape juice).

Indeed, the largest wine-producing region in New York State today is the Finger Lakes District, a development enabled in part by the 1976 Farm Winery Act, which permitted small wineries to sell wine directly to the public (as is customary in Europe). As written at “Finger Lakes winemaking industry matures, produces world-class wines“, CNY Business Journal (1996+), FindArticles.com, 26 May, 2009 :

Grapes have been grown in New York State for as long as there have been farmers here. There are four wine regions today: Lake Erie, Finger Lakes, Hudson River, and Long Island….

[T]he soil and climate of the Finger Lakes region are especially favorable for growing many of the European grape stocks. The lakes are deep and usually do not freeze over in the winter, so that winds coming across the lakes bring humidity and warmth to the vineyards.

[I]n 1976, the New York State Legislature passed the Farm Winery Act. This act made it economically feasible for farmers to have small wineries, because it allowed them to sell directly to consumers, liquor stores, and restaurants, instead of through a wholesaler or distributor.

Shortly after the passage of this bill, the largest of the wineries around the Finger Lake-Taylor, Widmer, and Great Western–were absorbed by the Canandaigua Wine Company….

In 1976 there were only 19 wineries in all of New York State. Today that number is around 250, with many of those wineries on the shores of the Finger Lakes.

As written in the reply affidavit of Robert Ransom (Index No. 08-275) to the Supreme Court of the State of New York, County of Ulster in a recent matter involving Rivendell Winery, LLC in the Hudson Valley (“1.” is missing since paragraphs are numbered from the beginning of the affidavit and not from the “A“):

A. THE FARM WINERY AS A BUSINESS

2. The sale of wine and other products in a winery tasting room are fundamental and foundational to the entire winery business. Like so many farms in different industries, without direct sales, there would be no business. Petitioner Rivendell relies on its direct-to-consumer sales for more than 99.2% of its sales. We have virtually no wholesale business.

3. The farm winery industry was founded on the concept of direct sales.Thirty years ago there were no farm wineries. In those days to be a winery in New York State legally required the sale of wine produced to be made through a series of distributors – what is commonly referred to as the “three tiered system” (producer sells to distributor who sells to retailer who sells to consumer). It was not legal for a wine producer to sell directly to the public. Also, a winery was allowed to procure grapes from any source, not restricted to the use of New York State-grown grapes.

4. In the early 1970’s a large upstate winery moved its production to California, effectively stranding several hundred grape growers for whom they were the largest customer. After several years of watching their grapes literally die on the vine, a number of grape growers got legislation enacted in New York State which allowed them to make wine and sell their wine directly to consumers. The NYS Farm Winery Act of 1976 was the enabling legislation that has since been emulated by virtually every State and is the basis for the Farm Winery or “boutique winery” industry that we belong to. N.Y. Unconsolidated Laws § 71, et seq. In 1985, the New York State
legislation was broadened to allow additional privileges to Farm Wineries and to further define allowable sources of raw materials. In that legislation it was clearly established that NYS Farm Wineries were required to utilize 100% New York State grown grapes to produce their wines, but were not required to grow the grapes themselves.

5. Without the ability to sell wine directly – through a tasting room or retail shop on the premises, virtually no farm winery in New York State would be able to economically survive….

24. The New York Farm Winery Act has become a model for winery legislation all over the country. Today, there are farm wineries, selling from their own tasting rooms, in every state of the United States. In New York today there are more than 250 farm winery licenses and every one located in an agricultural zone is permitted a tasting room (through which it makes its sales).

That reply affidavit supplies us with a lot of information about wine in New York, but the Rivendell Winery has thus far lost that case and has closed its doors because of the cost of the contested and bizarre zoning decision by the already infamous Hudson Valley town of New Paltz (see New Paltz in fiction), a decision confirmed in an unconvincing opinion by Gerald W. Connolly of the New York Supreme Court, County of Ulster, the lowest court in the New York Court system, which declared absurdly that winemaking was NOT agriculture. As written at the Wine Spectator:

Does processing and producing wine count as agriculture? Apparently in a small town in New York state it doesn’t. For nearly two years, Hudson Valley-based Rivendell winery fought a legal battle to build a mixed-use winery in the town of New Paltz, N.Y., but a recent court ruling, coupled with the rising costs of legal fees, has forced the winery to close. The winery’s founders, Robert Ransom and Susan Wine, were planning to move their 20-year-old winery to a property in New Paltz, with the intent of renovating an existing building into a winery and tasting room. Their plans came to an abrupt halt when a New Paltz building inspector determined that the proposed plan was not permitted under local agricultural zoning laws. When the town’s Zoning Board of Appeals supported the inspector’s ruling, the couple appealed their case to the New York Supreme Court. But Ulster County Supreme Court Judge Gerald Connolly recently ruled that the couple’s proposed farm winery was not permitted agricultural use. According to the Hudson Valley’s Daily Freeman, New Paltz resident David Porter applauded the decision. “Rivendell doesn’t even grow its own grapes,” he said. “They’re not agriculture, they’re commercial.” Unfiltered can only wonder how the négociants and cooperatives of Burgundy feel about this.” [LawPundit: emphasis added – in Europe, wine is agriculture, and in most cases, wine is agriculture also in the U.S.A. – with the exception of New Paltz]

Given the judicial opinion by Gerald W. Connolly in the Rivendell case, it would, by the logic of the reasoning in that case, be nearly impossible to put up a winery anywhere, because you can’t farm grapes on residentially zoned property, and you can’t process them on agricultural land. The New Paltz zoning interpretation essentially makes it impossible to have a winery in their jurisdiction and that can not be the law now can it?

See also the comment about this matter at Hudson River Valley Wineries.

Thankfully, the Finger Lakes District presents us with a much more positive picture of the New York State wine world. For a longer version of this post in this regard, see WinePundit.

What are the Best Blogs for Law Librarians? Online University Lowdown Focuses on the Importance of the Law Librarian in its Selection of the Best 50

We taught legal research in the Trier Law School FFA program for a number of years and remain convinced that research is the bread and butter of the legal profession. You have to know or be able to find the law. Often it is the latter.

Understandably, law libraries and law librarians remain as indispensable as ever.

Online University Lowdown has published its list of the 50 Best Blogs for Law Librarians.

Covered in that list of 50 are:

  • University Law Library Blogs
  • Law Librarian Blogs
  • Legal Research Blogs

LawPundit Mentioned in the New York Times Topics : Yuan News

Our previous LawPundit posting, How Much is the Dollar Worth? Past U.S. President Franklin D. Roosevelt’s (FDR) First Inaugural Address Shows why Greed Kills : Also in $$-Rich China, was mentioned in the New York Times Topics, the Yuan News of May 25, 2009, under the rubric “Headlines Around the Web” (we have added the red circle around the LawPundit link). Take a look at that NY Times website page, which has numerous links to stories about the Chinese currency, the Chinese Yuan, and especially its relation to the U.S. Dollar and the balance of trade.

Where to Invest One Million Dollars? Technology Company Executives Reveal Their Favorites : How about Cheap Kindles?

At the Reuters blog MediaFile, Tiffany Wu has a May 22, 2009 posting titled Tech execs, where would you put a million dollars?

Selected tech execs were asked at the Reuters Technology Summit: “If we gave you $1 million to invest anywhere — but not in your own company — where would you spend it?

The tech exec answers given provide some nice insights into today’s technology as well as the state of the world economy.

Take a look at the tech exec answers at this link.

Our own favorite answer, by the way, comes from Eli Harari, perhaps because we can – rightly or wrongly – also envision people and school children all over the globe using “cheap Kindles” down the road:

MISCELLANEOUS

  • I like very much these electronic readers. We actually started that several years back, we were ahead of the time, and we found that publishers, textbook publishers, were not very receptive. The area of flexible paper and digital paper and publishing. We’re not there yet. But (Amazon’s) Kindle is stepping in the right direction. There is a lot of innovation in that space. But it’s got to be like a $49.95 product, not a $300 or $400. It’s got to be for the masses. It’s got to bring educational qualities to kids in the Amazon, 1,000 miles away from civilization.

– SanDisk Chief Executive Eli Harari

Caveat emptor. No one really knows what the future will bring. But tell me one thing – who makes the batteries that make these things run?

LawPundit Posting on the Economy of Norway Mentioned in the New York Times World Topics : Headlines Around the Web

The New York Times apparently liked our previous posting about the NY Times article by Landon Thomas Jr. on Thriving Norway Provides an Economics Lesson, yesterday, May 23, including a mention of LawPundit and a link to our commentary on Thomas’s article which we titled Do it Like the Norwegians : Prudence, Stability and Sovereign Wealth Fund Legislation in Thriving Norway are an Example for the Rest of the World (we have appended the two red circles and the blue double-headed arrow to this partial scan and miniaturization of the respective New York Times World Topics page):

LawPundit at the New York Times

How Much is the Dollar Worth? Past U.S. President Franklin D. Roosevelt’s (FDR) First Inaugural Address Shows why Greed Kills : Also in $$-Rich China

As Dollars Pile Up, Uneasy Traders Lower the Currency’s Value” – that is the title of Jack Healy’s May 22, 2009 piece at the New York Times.

How Much is the Dollar Worth and What is it Likely to be Worth Tomorrow?

The opinions differ. Some have uncertainty and fear, but all that we really have to fear . . . is fear itself.

In his first inaugural address, past U.S. President Franklin Delano Roosvelt addressed and confronted the nation with the problems raised by what was then the depths of the Great Depression. President Obama is today in an analogous situation – having to pull the economy out of the hole into which it has dug itself. Here is an excerpt from FDR’s words, which are still quite applicable today:

This great Nation will endure as it has endured, will revive and will prosper . . . the only thing we have to fear is fear itself…. [W]e face . . . common difficulties. They concern, thank God, only material things….

Yet our distress comes from no failure of substance. We are stricken by no plague of locusts. Compared with the perils which our forefathers conquered because they believed and were not afraid, we have still much to be thankful for. Nature still offers her bounty and human efforts have multiplied it. Plenty is at our doorstep, but a generous use of it languishes in the very sight of the supply. Primarily this is because the rulers of the exchange of mankind’s goods have failed….

They know only the rules of a generation of self-seekers. They have no vision, and when there is no vision the people perish….

The measure of the restoration [of the economy] lies in the extent to which we apply social values more noble than mere monetary profit. Happiness lies not in the mere possession of money; it lies in the joy of achievement, in the thrill of creative effort.

The joy and moral stimulation of work no longer must be forgotten in the mad chase of evanescent profits. These dark days will be worth all they cost us if they teach us that our true destiny is not to be ministered unto but to minister to ourselves and to our fellow men.

[Confidence in the future] thrives only on honesty, on honor, on the sacredness of obligations, on faithful protection, on unselfish performance; without them it cannot live.

Read the full text of the inaugural address here.

The solution, now as then, is to roll up our shirtsleeves and get to work.

Whether in deflation or inflation, the dollar, higher or lower in value, will surely survive.

And to learn that money is not everything, one has to read about the problems that China has simply because it has too many dollars, 2 trillion of them. Paul Krugman in his April 2, 2009 article at the New York Times clues us in on China’s Dollar Trap.

There is a lesson here: greed kills.

Do it Like the Norwegians : Prudence, Stability and Sovereign Wealth Fund Legislation in Thriving Norway are an Example for the Rest of the World

Norway is doing something right that many of the countries in our world are doing wrong, namely running the national economy wisely.

Is Norway a model for a healthy and prudent national economics?

Landon Thomas Jr. in his May 13, 2009 New York Times article Thriving Norway Provides an Economics Lesson gives us a nice summary of the economic policies followed by a “wealthy” but “relatively frugal” country. Of course, it helps that Norway is the world’s third largest exporter of oil and in 2008 counted $68 billion in oil revenue. But that is not the whole story.

As Thomas writes:

[I]n the midst of the worst global downturn since the Depression, Norway’s economy grew last year by just under 3 percent. The government enjoys a budget surplus of 11 percent. By comparison, the United States is expected to chalk up a fiscal deficit this year equal to 12.9 percent of its gross domestic product and push its total debt to $11 trillion, or 65 percent of the size of its economy….

Norway’s relative frugality stands in stark contrast to Britain, which spent most of its North Sea oil revenue — and more — during the boom years. Government spending rose to 47 percent of G.D.P., from 42 percent in 2003. By comparison, public spending in Norway fell to 40 percent from 48 percent of G.D.P.

‘The U.S. and the U.K. have no sense of guilt,’ said Anders Aslund, an expert on Scandinavia at the Peterson Institute for International Economics in Washington. ‘But in Norway, there is instead a sense of virtue. If you are given a lot, you have a responsibility.’

Read the full article to find out why Thomas writes:

The global financial crisis has brought low the economies of just about every country on earth. But not Norway.

Linex Legal : Forget it : This Allegedly Free Service Is Not Free For Everyone : Possibly Illegal Discrimination on the Basis of the Email Provider

As someone who is retired from teaching law at the university level, I nevertheless keep up on legal developments worldwide, inter alia, also co-authoring the world’s leading (Langenscheidt-Routledge) German-English dictionary on business, commerce and finance and also doing legal work for the European Commission.

Recently, I ran across an outfit called Linex Legal at LinexLegal.com (apparently based in the UK) which allegedly offers a free legal newsletter service. They write at their website:

Sign up for a free account

Discover what you have been missing. Sign up now for your free account and access all the latest updates and reviews covering your area of interest.

When I went to the registration page at the Linex Legal registration page, they – however – had the following proviso:

If you register with a public email address (hotmail, yahoo, gmail etc), your access to Linex may be restricted.

Hmm. Can one – as a matter of law – offer a free online service in come-on advertising, without CLEARLY and EXPRESSLY limiting that come-on accordingly, and then discriminate against certain preselected public email providers at the registration page? I doubt it.

OK. I did want to see what this service was all about – more out of curiosity than out of any expected utility – so I registered for the allegedly free service with my personal Stanford Alumni address, and got the following reply:

Unfortunately – being a business to business tool – we can only accept registrations with an academic email address.

I suppose from that statement that they only offer their free service to those who are actively getting paid by academic institutions and from whom some kind of a business-to-business commercial or advertising advantage at such institutions appears obtainable in the short or long term.

In other words, the “free” advertising aspect is just a come-on for commercial ends.

Now, in our view, either such law sites are offering a free or a commercial service – nothing wrong with that, as long as the service is truthfully labelled – but the “free” misleading come-on in the Linex Legal advertising is not suitable for the legal field and in our opinion, unless clearly, expressly, and openly advertised as being free for only a select group of persons, i.e. for those with active academic email addresses, it would appear to us that the Linex Legal advertising is clearly misleading and thus fraudulent as a matter of law.

The harm to persons such as myself is that I wasted a good bit of my valuable time registering for a free service which actually was not intended to be free for me – and I am quite angry about that. Time is my most valuable commodity and I do not have a mind to award it for free to outfits like Linex Legal. I have a mind to bill Linex Legal for my lost time -and that bill would be quite expensive – and rightly so.

Change in the Pharmaceutical Industry : USA, UK & Europe, especially Germany : Working Paper by Harvard’s Daemmrich Summarized by Rob Houck

LawPundit: The following summary by Rob Houck (here published with the author’s consent) of a working paper by Arthur Daemmrich of the Harvard Business School came to our attention indirectly via assistance from Janine Labusch. Thank you. Materials in [brackets] have been added viz. modified by LawPundit, e.g. an updated URL reference.
_____________

Summary by Rudolph (Rob) Houck, Eaton & Van Winkle LLP, 3 Park Avenue, 16th floor, NYC, NY 10016, 212-561-3608, rhouck@evw.com, May 6, 2009 of WHERE IS THE PHARMACY TO THE WORLD? INTERNATIONAL REGULATORY VARIATION AND PHARMACEUTICAL INDUSTRY LOCATION, Working Paper 09-118, by Professor Arthur Daemmrich, Harvard Business School.

The Harvard Business School publishes a weekly on-line newsletter announcing its faculty’s new research. Many of the articles are interesting and offer insights into commercial, legal and political questions. Professor Daemmrich’s research is particularly interesting because it compares trends in the US and German pharmaceutical industry and their causes. This memo summarizes his “working paper.” A complete copy is available at [http://www.hbs.edu/research/pdf/09-118.pdf].

DISCLAIMER/DISCLOSURE: This summary was prepared [by Rudolph (Rob) Houck] from a public source, without the input or approval of Professor Daemmrich. Some sections are taken directly from his Working Paper but not put in quotation marks [LawPundit: we have for purposes of this paper added quotation marks where appropriate since Houck’s article was originally not intended for publication, and we requested to publish it.].

SUMMARY: Two models of drug development have developed: one which focuses on mass-marketing blockbuster drugs and a newer, consumer-oriented model. Another development is the increased influence of “patients and disease-based organizations in defining disease categories,” structuring clinical trials and making regulatory decisions. Prof. Daemmrich notes this second trend is prevalent in the US and not in Germany and may have helped the US take over world leadership in the pharmaceutical industry.

INTRODUCTION: Pharmaceutical companies are products of both the free market and intense regulation. They play a major role in national economies. Important recent factors include: rising costs, increased attention to adverse reactions, and to “lifestyle treatments” and less attention to serious diseases. Government policies vary regarding drug price controls, enforcement of safety laws and post-market monitoring.

Since 1980, Germany’s historically dominant pharmaceutical industry has declined, even compared to Switzerland and the UK. During the same period, the US’s industry has flourished. Both countries have “advanced technologies, significant” government and insurance “spending on biomedicine, support for new therapies and large patient markets”. The important differences Prof. Daemmrich identifies are the role of government regulation and the role of patients as actors. The US Food and Drug Administration centralizes safety regulation while Germany has a “network of physicians, industry and government officials”. In the US, disease-based organizations affect innovation and regulation. Not so in Germany.

Despite having research done in many countries, the pharmaceutical industry creates great benefits for the home country, through high-paying, skilled jobs and tax revenue. The home country itself also has greater and earlier access to the resulting new drugs. These companies are viewed as “national assets.”

Drugs are regulated on a national basis: research, “testing, marketing and pricing”, and these regulations vary widely from country to country. Other influences on drugs are also organized on a national basis: oversight of “the medical profession, pharmacists, and organizations” representing patients. Countries differ on how they “define “the patient” (who benefits from safe, effective, affordable therapies)” and “the consumer” (who desires protection and choice).

Prof. Daemmrich identifies a tension between (a) the influence of consumers on regulation and (b) the responsibility of consumers to seek out their own information on pharmaceuticals, treating prescription drugs like other consumer goods. He rejects studies which show that the industry is moving to countries with lower labor costs and weaker regulatory systems. The industry remains concentrated in the US and Europe, where barriers to drug approvals are high.

Prof. Daemmrich looks at how the US and Germany reacted differently to “a new disease (HIV/AIDS), demands by terminally ill patients” for “new drugs and personalized medicine”. The US changed its regulations in response to these forces, becoming more consumer-oriented, while still retaining “procedure-based decision processes”. In contrast, he thinks Germany’s more complex system “of shared authority (the medical profession, other “peak associations” and the state)” combined to weaken Germany’s pharmaceutical industry. This tension between regulation and innovation were decisive in shifting the industry from Germany to the US.

HISTORY: In the 1970’s the US pharmaceutical industry was on the decline. The causes were regulatory caution, the costs of clinical testing and weak innovation. In 1974, 5 of the top 10 pharmaceutical firms were located in Germany or Switzerland. Only one French firm and no UK firm were in the top 15. By 2005, 9 of the top 15 were based in the US and only one – Boehringer-Ingelheim – was in Germany. Furthermore, the sales by the largest firms have increased rapidly since 1988, partly through merger, but largely through innovation as “pharmaceuticals …become high-demand consumer products.” The size of the US market is not determinative – 3 of the top four firms are based in Europe. The same trend is evident in spending on research. In the 1970’s the US spent much less than European firms on research. Now US pharmaceutical firms spend three times what European firms do, a growth rate of 6 times. This is not a simple matter of European cost containment. German and French firms also introduced fewer new chemical entities. From 1997 through 2007, US firms had 40% of all FDA approvals and Germany only 6%.

2007 US pharmaceutical sales totaled $663.5 billion, but only $32.2 in Germany, $29.6 in France and $17.4 in the UK. In 2008, the US had “twice as many clinical trials” as in the EU. A.T. Kearney ranks countries in terms of their attractiveness for clinical studies: US, China, India and Russia, with Germany number 10. Dr. Daemmrich ties clinical studies closely to research, investment and market approval. Germany’s weakness in this area (clinical studies) is due to the country’s high costs, low patient population and difficulty in recruiting participation (possibly due to the ready availability of drugs to all economic classes in Germany – RSH). More attractive are the Czech Republic, the UK, Poland and Hungary.

Of course price controls “in Europe and their absence in the” US play a significant role.

Bain notes three advantages in the US: “government support for basic biomedical science, investors’ risk tolerance in supporting new” companies and cooperation between industry and university scientists. Bain put the cost to Germany at $5 billion due to lowered access to drugs and jobs, jobs which went to the US.

RECENT US DEVELOPMENTS: In the 1960’s the US was greatly affected by equality of access and protection from dangerous compounds such as thalidomide (Contergan). But US public attitudes shifted back towards more risk tolerance in the 1980’s. New disease-based interest groups pressured Congress for more funding and monitored it more closely. The internet increased the size of these groups and their effectiveness. Groups interested in HIV and breast cancer in particular exerted pressure for research, lower drug prices and regulatory review. The debate in Europe was focused more on prices, equality of access and protection from dangerous compounds. A new, “consumer mode” of regulation took hold in the US, while administrative approaches continued in Europe.

Professor Daemmrich next cites (1) HIV-AIDS, (2) terminally ill patients and (3) personalized medicine (drugs based on individual genetic makeup and efficacy) as important factors in the recent development in US drug regulation. These three factors are discussed below:

  1. With the outbreak of HIV-AIDS in the US, pressure for faster approval of drugs could be focused on one central body, the FDA. The German system shares “regulatory authority among government officials, the medical” profession and industry, so there was no one physical or administrative site where pressure could be exerted. Germany’s more comprehensive medical care also reduced pressure for change. In contrast, under pressure from gay activist groups, the FDA approved the first anti-AIDS drug in only 107 days. The agency began to issue rules to expedite availability of experimental drugs. The standard of approval changed to “reasonable basis” for concluding that a drug would not expose patients in clinical trials to “significant additional risks”. In 1992 “AIDS patients who were not” participating in clinical trials got access to those drugs. Pressure further changed FDA rules regarding the minimum number of clinical trials, patient screening, placebo use and restrictions on trial participants. The FDA also approved drugs based on indicators other than long term survival, such as changes in T-cell count. In contrast, German gay men and supporters worked on prevention and education. One organization, Deutsche AIDS-Hilfe, became the sole representative of AIDS patients and a “quasi-public” administration. Being part of the establishment, it did not use “confrontational techniques to bring about” change. The German government wanted one organization with which to deal, to operate within official channels. It focused on public education, insurance and daily assistance to patients. The few confrontational organizations in Germany were not taken seriously. The German government decided that the 1976 Drug Law anticipated new diseases like AIDS and did not have to be changed. The German Federal Health Ministry (BGA) focused on reducing duplicate tests and time spent on animal testing. Professor Daemmrich sees this response as one limited to technical details. The boundaries between experts and patients remained unaffected. Germany’s failure to test its blood supply led to splitting the BGA but not to bring about a confrontation “between insiders and external critics”. The newly formed government agencies operated like the old one. The public put little pressure on the German network of physicians, regulators “and the pharmaceutical industry”.
  2. In the US, drugs may be used as prescribed by doctors, whether or not approved for that use by the FDA. Still, the drug must be approved for at least some use before it is available outside clinical trials. Furthermore, requirements that drug companies report and investigate adverse reactions and fatalities complicate matters. The courts played a role in policy making here. A suit was brought to require access to medications whose safety and efficacy was still questioned. The appeals court then held that the testing traditional procedures – involving large, double-blind, placebo-controlled studies – were required. The efficacy of studies was dependent on patients volunteering as subjects and that efficacy would be undermined if patients had uncontrolled access.

    In contrast, in Europe access to pre-approval drugs is “the responsibility of physicians and pharmacists, with” the government playing a smaller role. Professor Daemmrich suggests that the greater tension in the US between the government and the patient has resulted in affirmation of the importance of clinical studies. The European procedure permits compassionate use but leads to less certainty for pharmaceutical companies.

  3. Regulators in the US and Europe are looking for “biological markers” as a means of judging the efficacy of new drugs in individual patients, an aspect of “personalized medicine”. Although a subject of debate in both areas, the public reimbursement programs in Europe make cutting off funding and therefore access to some drugs more uniform.

    The US has developed the Critical Path Institute, a non-profit organization to coordinate among the FDA, industry and academia, to develop new biomarkers. Professor Daemmrich predicts that the European equivalent, the Innovative Medicines Initiative, will spend more of its funds on “brain disorders and metabolic disease than” on biomarker development and the development of new clinical trial methods. He says that the FDA is taking a more active role in this process than European agencies.

    Finally, the US and Europe are taking different paths regarding drug delivery. In the US, the trend will be towards “genetically based diagnostic tests and personalized, targeted” pharmacological treatments. In Europe, discussions are more technical and focus on healthcare cost savings which could result from new testing methods. In Europe, drug accessibility is an “all or none” proposition.

CONCLUSION: The emergence of the US as “pharmacy to the world” results from well-recognized factors such as US “intellectual property policies, “funding for biomedical research” (NIH), “absence of government” price controls and “the availability of venture capital”. Professor Daemmrich adds to this list the regulation of clinical trials and its reform.

Government regulations reflect “a country’s innovation concept”, but also cultural differences. In the US, regulations shifted from protecting the consumer from the effects of capitalism to providing “greater access to drugs and speedier approvals”. US policy makers also recognized the importance of “the pharmaceutical and biotech sectors”. The “boundary between testing and marketing” has been softened. The regulatory process in the US has moved from the “medical profession to the state” and now to a “new consumer/patient oversight model.”

In contrast, in Germany, “the medical profession exercised a near-monopoly over” the concept of “the patient.” There, “drug laws codified existing power-sharing arrangements”. The German state did not claim “authority over pre-market testing”, but rather was only one member of a network. The German medical profession maintained and “expanded its authority to speak for the” patient. Few disease-based organizations even tried to change the regulatory system. Hence, the drug approval process seldom is a subject of debates regarding “national competitiveness or industry” motivation.

The recent emergence of a US “consumer/patient regulatory mode has driven increased use of prescription drugs”. This avoids the “cost vs. life decisions” confronted in England. One risk in the US is patient groups which are really formed by industry and subject to industry manipulation. Another risk is the focus on diseases “prevalent in wealthy countries, to the” neglect of third world diseases.

X-Life : Using Mobile Cellphone Technology as Cultural e-Diplomacy : Can Game-Playing be Useful as a Form of Education in the International Sphere?

4 BILLION cellphone subscribers worldwide. Incredible. About 4 times as many as Internet users. Now, that is an eye-opening statistic for this posting.

Having taught at a law school for a number of years, the LawPundit has a cutting edge interest in teaching, learning and education. So where is the future leading us in this regard and what media are best suited for the learning purpose?

At ABC News, via an ad at America.gov, there is a video at Ahead of the Curve interviewing Metrostar Games CEO Ali Manouchwhri regarding X-Life Games and Acquainting Cultures With Technology, in this case via the intercultural mobile cell phone game X-Life as a form of e-Diplomacy.

As written at the X-Life Games website in Launch of X-Life Games Heralds New Era for U.S. Diplomacy:

Mobile Gaming Technology Pioneers e-Diplomacy Outreach to the Middle East and Persian Gulf

RESTON, Va.–(BUSINESS WIRE)–

MetroStar Systems, Inc., a leader in New Media technology solutions for the federal government, announced today the much anticipated release of X-Life Games and its availability for free download on www.xlifegames.com. Developed by MetroStar Systems, X-Life Games is an English language mobile game that encourages cultural exchanges between Arabic, Persian, and English speaking cultures, demystifies American culture, and breaks down barriers that impede mutual understanding. Leveraging the latest in mobile technology, X-Life users in the Middle East and Gulf region will be introduced to American culture in a non-threatening and constructive manner.

Marisa Taylor writes at the Wall Street Journal blog Digits:

The game has two different role-playing modules, one in which a user’s avatar is a student studying abroad in the United States, and the other is a musician in a Guitar Hero-like scenario (Grammy-winning band Ozomatli contributed a song for the game).

Users win points by answering questions or solving puzzles about U.S. history and culture correctly, with the aim of getting users to follow their avatar to the X-Life Web site and chat with other users.“

Can that possibly work?

Read Taylor’s article to find out the whys and wherefores and how successful things have been thus far in the e-diplomacy game.

What is Democracy? Democracy is … Voting has Begun : Cast Your Vote at YouTube in the Worldwide Democracy Video Challenge : 6 Geographic Regions

What is Democracy? Democracy is …

VOTE NOW

As written at America.gov:

Vote for the Video that Defines Democracy Best

The Democracy Video Challenge is an online video contest in which contestants submitted videos that explore the nature of democracy. People worldwide can select a winner by voting between May 15 and June 15 for the video that best captures the nature of democracy.

Richard Engel at the Democracy Video Challenge has opened the voting starting today.

Cast your vote at YouTube.

VOTE NOW

What is Democracy? : PUBLIC Online YouTube Voting in the Worldwide Democracy Video Challenge Final Begins May 15 and Runs to June 15


America.gov staff writer Tanya Brothen has an article on the Democracy Video Challenge, an online video contest which was launched at the United Nations on September 15, 2008 and for which online voting beings on May 15, running to June 15, 2009, i.e. voting begins TODAY. In Films Highlight Hundreds of Definitions of Democracy, Brothen wirtes:

Filmmakers from more than 90 countries submitted about 900 videos, displaying a variety of opinion, vision and creativity.” [900 videos represent 580 applicants]

There were 196 video semifinalists, viewed on May 7 at the Smithsonian’s Hirshhorn Museum in Washington D.C and 21 finalists will be selected today, May 15, of which seven will receive prizes in the voting. See the contest rules. See also Facebook.

As Brothen informs us:

Award-winning filmmaker and documentarian Michael Apted and Peruvian economist Hernando de Soto will oversee the competition’s selection of 18 finalist videos, to be announced May 15. They will select three films from each of six regions (Western Hemisphere, Europe, Middle East/North Africa, sub-Saharan Africa, South and Central Asia and East Asia/Pacific).

The public will select the winning videos by voting online from May 15 through June 15 at www.youtube.com/democracychallenge. The winners will receive an all-expenses-paid trip to Washington, New York and Hollywood, where they will spend time on television and film sets; meet with film professionals, democracy advocates and government officials; and attend special screenings of their videos.

There are actually 18 world geographic finalists plus three anonymous finalists, for a total of 21 finalists, as the Video Challenge Rules write as follows:

Round 2: An independent panel of judges comprised of film experts and democracy and youth organizations will evaluate the semifinalists. They will choose three finalists from each of the six world geographic regions as defined by the U.S. Department of State (Western Hemisphere, East Asia Pacific, Europe, Africa, Near East, South & Central Asia) and three anonymous finalists for a total of twenty-one finalists, which will be revealed on the Contest site (www.youtube.com/democracychallenge) on or about May 1, 2009.

Round 3: The twenty-one finalist Videos will be posted on the Contest site in mid-May 2009, and the general public will have one month to vote for their favorite videos using YouTube’s rating system. One grand prize winner from each of the six world geographic regions and one anonymous winner will be announced on or about June 15, 2009.

The demvidchallenge is using Twitter, where one can keep up on what is happening. See http://twitter.com/demvidchallenge

Update of the Paul, Weiss Reference Guide to U.S., European (EU) & Global Legislative and Regulatory Measures to Deal with the Financial Credit Crisis

Paul, Weiss has just issued a comprehensive updated edition (May 6, 2009) of A Reference Guide to the Financial Crisis Rescue Efforts, such as are being taken via legislative and regulatory measures in the United States, Europe (European Union, United Kingdom, Germany, France, Italy, Ireland, The Netherlands, & Other European Countries) and also on a Coordinated Global basis. As written at the 124-page Guide:

In view of the multifaceted and evolving nature of the U.S. government’s response to the financial crisis, we have developed this reference guide to the principal regulatory programs and initiatives that have been announced to date. The guide summarizes the U.S. Treasury programs implemented under the Emergency Economic Stabilization Act of 2008, the administration’s Financial Stability Plan and other key programs implemented by the Federal Reserve and the Federal Deposit Insurance Corporation. The guide also summarizes the principal actions taken by European governments and the G-20 in response to the global credit crisis. This guide should be read in conjunction with the update alerts and other materials posted on our web site portal dedicated to the financial crisis.

View the full text of the PWFCRG.

Andis Kaulins Hitting a 300-yard Drive : Golf-Club Cochem/Mosel Driving Range

Andis Kaulins Hitting a 300-yard Drive from Andis Kaulins on Vimeo.

Andis Kaulins Hitting a 300-yard Drive

Well, I nearly fell on my head on that one. I by no means have a perfect swing. But I won my club’s men’s championship in 2008 at age 61. It is the speed of the swing that makes for distance, determined mostly by a quick body turn at impact. If you look carefully, you will see that I barely cock my wrists. I won the longest drive competition in one tournament in 2008 with a drive of 340 meters (about 370 yards). But remember, drive for show and putt for dough. For scoring it is the short game that counts.

France Defies European Union and Passes Controversial Anti-Piracy Three Strikes and You’re Out Creation and Internet Law Against Illegal File-Sharing

The French National Assembly of the Fifth French Republic, the lower legislative chamber in the bicameral Parliament of France, has passed the “three strikes and you’re out” anti-piracy “Creation and Internet Law”, also called the “Three-Strikes Law” against illegal file-sharing and it is expected that the upper house, the French Senate, will also pass the law tomorrow.

As written at ZeroPaid.com:

Today the French National Assembly formally passed the controversial “Creation and Internet” law by a narrow 296 to 233 margin.

The legislation, backed by President Nicolas Sarkozy, and surprisingly defeated in the same body last month, calls for the creation of the Haute Autorité pour la Diffusion des Oeuvres et la Protection des droits sur Internet (HADOPI), a new govt agency whose task it would be to sanction those accused of illegal file-sharing.

The law is controversial in the European Union because it directly defies efforts of the EU Parliament in recent weeks to make the Three Strikes Law illegal through telecom law amendments which make internet access a fundamental right of EU citizens. As reported by La Quadrature du Net:

“A formidable campaign from the citizens put the issues of freedoms on the Internet at the center of the debates of the Telecoms Package. This is a victory by itself. It started with the declaration of commissioner Viviane Reding considering access to Internet as a fundamental right. The massive re-adoption of amendment 138/462 rather than the softer compromise negotiated by rapporteur Trautmann with the Council is an even stronger statement. These two elements alone confirm that the French ‘three strikes’ scheme, HADOPI, is dead already.” explains Jérémie Zimmermann, co-founder of La Quadrature du Net.

It thus has all the makings of an upcoming confrontation between the French Parliament and the Parliament of the European Union.

The passage by the French Assembly had an immediate reaction in the United Kingdom, as reported by Nigel Kendall, Technology Editor at the Times Online, who writes that the UK is the latest country in Europe to formulate a strategy to combat illegal online file-sharing:

A group representing the UK’s creative industries today called for the UK government to intervene to prevent the spread of illegal file-sharing of copyrighted content such as music and film.

The group, a loose coalition that includes The British Phonographic Industry and the Film Distributors’ Association, as well as trades unions such as the National Union of Journalists and the Musicians’ Union, issued a joint statement following a meeting in London on May 12.

There is in the long term of course no question that the days of illegal fire-sharing are numbered, since large parts of the world economy are built on intellectual property rights which have to be defended. The French law is taking the logical approach by providing for the tracing of illegal file-sharers and a three-strikes and you are out policy toward them, leading to the cutting of their Internet connections. As written at the Hollywood Reporter:

The “Creation and Internet” law, nicknamed the “Hadopi” because it involves the the creation of a Hadopi (High Authority for the Broadcast of Content and the Protection of Rights on the Internet) committee, authorizes the tracing of illegal downloaders through their IP addresses.

Once illegal downloaders are faced with the consequence that their Internet connections will be cut off, illegal file-sharing will drop quickly since the average citizen will not want to take that risk and will thus no longer engage in what he or she knows to be illegal file-sharing, but which currently has little risk of detection or penalties.

We presume that a compromise political and legal solution will be the recognition of Internet access as a fundamental right of EU citizens, provided that they do not engage in illegal activities via that very same Internet. We see no direct confrontation to be necessary here.