Showing posts with label Drug patent extension. Show all posts
Showing posts with label Drug patent extension. Show all posts

Thursday, October 8, 2015

TPP degrades democracy results in less competition

- The announcement that an agreement was reached by the 12 nations negotiating the Trans-Pacific Partnership(TPP) has resulted in considerable discussion and debate on the pact.
The text of the agreement has never been made public and it is not clear when the text will be released. The details released are probably released by parties whose interests are involved. Many critics of the TPP complain about the secrecy and lack of transparency in the process. There is much discussion of the impact of the deal on agriculture sectors such as dairy farmers who have a supply-managed system. While the agreement does open the system somewhat to allow more imported products into Canada, the basic supply management system remains. The negative impact of the changes will be muted through compensation paid to the industry courtesy of the Canadian taxpayer. The auto parts industry will also be hurt with many jobs lost. Again Harper promises billions of taxpayer money to mute the negative impact.
There is less discussion of other significant aspects of the agreement. The TPP, as with other trade agreements such as NAFTA, is less about free trade and more about placing the power of global corporations beyond the reach of democratic governments. Ironically, our government quite consciously bargains away our right to pass laws and regulations as we see fit. If we pass laws or regulations which are considered inconsistent with the TPP, a foreign corporation can sue Canada.
A leaked text of part of the TPP includes an investor-state dispute settlement(ISDS) very much like the already existing mechanism in Chapter 11 of the North American Free Trade Agreement. Wikipedia describes an ISDS as follows: Investor-state dispute settlement (ISDS) is an instrument of public international law, that grants an investor the right to use dispute settlement proceedings against a foreign government. Provisions for ISDS are contained in a number of bilateral investment treaties, in certain international trade treaties, such as the North American Free Trade Agreement (Chapter 11)...If an investor from one country (the "Home State") invests in another country (the "Host State"), both of which have agreed to ISDS, and the Host State violates the rights granted to the investor under public international law, then that investor may bring the matter before an arbitral tribunal.As mentioned, NAFTA contains such a provision.
There have been many cases in which Canada has been sued by foreign corporations. In August 2008 Dow Chemicals submitted a claim for losses caused by a Quebec ban on the sale and certain uses of pesticides containing 2-4 D. In this case, the two sides reached a settlement accepted by the tribunal. States cannot sue corporations under the ISDS nor can they receive any compensation should a corporation lose except for their legal costs in some cases.
Canada has already lost seven cases under the ISDS process and paid out damages of $190 million and who knows how much in legal fees. One case filed against Canada challenges a Quebec ban on oil and gas fracking in the province. An analysis of cases under the NAFTA provisions can be found here:This study documents the 77 known NAFTA investor-state dispute settlement (ISDS) claims up to January 1 2015. These include 35 against Canada, 20 against the U.S., and 22 against Mexico. Canada has paid out NAFTA damages totaling over $CAD172 million, while Mexico has paid damages of $US204 million. The U.S. has yet to lose a NAFTA chapter 11 case. All three governments have incurred tens of millions of dollars in legal costs to defend themselves against investor claims.
In Europe, the issue of ISDS mechanisms has been hotly debated The EU parliament has passed a resolution that will require replacing an ISDS system in the Transatlantic Trade and Investment Partnersip(TTIP) ".. by a new public and transparent system of investment protection, in which private interests cannot undermine public policy and which is subject to public law." Brazil refuses to sign any treaty with ISDS clauses. South Africa intends to withdraw from any treaties that have ISDS clauses. In Canada the politicians of the major parties appear to think the issue is not worth bringing into public debate. What is significant are issues that impact specific interests such as the dairy industry or auto industry, where the parties might win or lose votes if they take the wrong position. That the democratic system itself is endangered and more power given to global corporations does not seem important.
If provisions in the TPP allow more penetration of global corporations into new markets such as the Canadian dairy and auto industry then competition will be fostered but in general the exact opposite is the case. In any free trade deal there are always clauses extending copyright and patent lengths, giving corporations monopoly rights over their products. We can expect the costs of drugs to our health care system to increase dramatically as a result of the TPP. It will become more difficult for producers of less expensive generic drugs to be able to replace drugs protected by patents. Protection of copyright terms in the TPP will prevent free or less expensive copied version of items:In the area of copyright, the TPP would require far longer terms of protection than what Canadians agreed to in a parliamentary copyright law review that only wrapped up recently. To smooth the way for the TPP, the federal government has already agreed, in the latest omnibus budget bill, to extend copyright terms for audio recordings from 50 to 70 years. The TPP could also require protection for controversial “digital locks,” which allow copyright holders to encrypt software in computerized devices and criminalize its circumvention.We do not know exactly what will be in the final text. With provisions such as these in the leaked text, it is not surprising that the final text will probably not be released until after the election.


Friday, November 16, 2007

Evergreening. How to extend drug patents and keep out competition

The evergreeners are also the people who feted Mulroney, not that the Liberals were any better. They both are in the pockets of the drug companies. It is amazing that we actually have a body that to some extent controls the prices of drugs and keeps us well below US prices. Even so we are nowhere near as progressive re drugs as such as Norway. At least evergreening has at last been stopped or at least I assume it has been. This is from the following site.
CMAJ • December 5, 2006; 175 (12). doi:10.1503/cmaj.061513.
© 2006 CMA Media Inc. or its licensors


Articles by Kondro, W.
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Medicine and the Law (including Forensic Medicine)


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Supreme Court rules against drug patent "evergreening"
Wayne Kondro
CMAJ

It has become almost axiomatic in the pharmaceutical world that litigation has replaced innovation as the primary mode of operation, says the head of the Canadian Generic Pharmaceutical Association.

The Supreme Court of Canada tossed another salvo into that litiginous world Oct. 3 by ruling that the controversial practice of evergreening — which allowed brand-name pharmaceutical firms to obtain an automatic 2-year extension on the term of patent protection by filing new patents of an altogether marginal nature, such as the shape, dosing range or colour of a pill, and then claiming infringement on its original patent — should not have been allowed under Health Canada's old drug regulatory regime.

This latest decision overturned a lower-court ruling to quash Apotex Inc.'s notice of compliance to market a knock-off of the AstraZeneca proton-pump inhibitor, omeprazole, which was sold in Canada from 1989 to 1996. The drug was removed from the market and its patent expired in 1999 but AstraZeneca used the regulatory system to successfully trigger a series of successive 24-month "stays" to prevent Health Canada approval of a lower-cost generic equivalent.







In his October decision, Mr. Justice Ian Binnie wrote that "Given the evident (and entirely understandable) commercial strategy of the innovative drug companies to evergreen their products by adding bells and whistles to a pioneering product even after the original patent for that pioneering product has expired, the decision of the Federal Court of Appeal would reward evergreening even if the generic manufacturer (and thus the public) does not thereby derive any benefit from the subsequently listed patents."

Given that the government of Canada moved a month before the ruling with new regulations to limit evergreening to instances in which there is proof of actual infringement of the original patent, the decision was somewhat of a pyrrhic victory for the generic industry.

Nevertheless, Canadian Generic Pharmaceutical Association president Jim Keon was "very pleased. We've felt all along that these evergreening practices were problematic and costly for consumers."

Keon also argued consumers will bear the financial brunt of the Oct. 5 amendments to the Food and Drug Regulations to extend data protection on brand-name drugs from 5 to 8.5 years (including 6 months pediatric exclusivity), as well as eliminate the ability of generic firms to make damage claims for profits made by a brand-name company while it's using evergreening to delay competition.

If a generic product is now held off the market because of a protracted legal dispute, its' maker can now only seek redress for its own lost profits, Keon lamented. "Any disincentive is now gone. If I were the CEO of a brand name company, I'd be telling my legal people, let's see how many patents we can get, how many various aspects we can patent and then list every one of those and litigate to the maximum. If successful, fantastic. We get the extra profits. If the court later on finds against us, we'll pay a small fine for that because there's no other downside."

Canada's Research-Based Pharmaceutical Companies (Rx&D) spokesman Francois Lessard says they have no comment to make on the decision other than that it "is commercial in nature and applies to a single product. The association doesn't have a commercial mandate."

Conservatives keep their distance from former PM

Not only is this interesting as showing the party "faithful" as avoiding contamination by the former Prime Minister and buddy of Harper--who probably helped him a lot during the last election campaign and since--but also because of the event. Mulroney is being feted for extending drug patent legislation, an extension that put billions in the pockets of the big drug manufacturers and also increased the cost of drugs for all of us. No wonder he is being feted.
I have appended part of another article on the high cost of drugs. In my next post I include an article on evergreeining by which drug companies extended their patents even beyond twenty years keeping out generic drugs even longer.


Friday » November 16 » 2007

Tories lose appetite for dinner with Mulroney
Conservatives keep their distance from former PM

Don Martin
National Post


Friday, November 16, 2007


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MONTREAL -- Brian Mulroney huddled with wife, Mila, and a few faithful in a hotel suite on Thursday evening. When the dinner bell rang, the former prime minister shook hands with his "true friends" before heading for his first Quebec appearance as a Conservative outcast.

As featured recipient of the Rx&D Health Research Foundation's Medal of Honour for his former government's 1987 legislation to extend drug patent protection, the Mulroney drawing card had sold out the 500-seat gala weeks ago.

But dozens of empty chairs for the speech reflected his startling reversal of fortunes, now that his business affairs with arms dealer Karlheinz Schreiber are heading for a public inquiry.

At some tables, a third of the chairs weren't taken. Several guests confided to me they were last-minute invitees and didn't really know why they'd been chosen, except to squish a seat cushion.

This is what a boycott looks like when a current prime minister erects a firewall between his government and a former prime minister.

Just one week ago, Prime Minister Stephen Harper imposed a government-wide Mulroney isolation order until unproven allegations of a cash-for-planes deal are cleared up.

Ottawa organizers, who had promoted the Mulroney salute as a rare opportunity to mingle with the government caucus, confided that 17 Conservative MPs, including Health Minister Tony Clement's office, had backed out or simply not turned up.

The only Conservative of any parliamentary stripe recognized from the podium was former party bagman Senator David Angus. Mulroney loyalists tried without success to cajole a few words of praise from him for the record, but he looked over at me like I was a drill-armed pain-fetish dentist.

Even Grits seemed squeamish at the thought of being recorded as having shared the same physical space as Mulroney. Former Liberal cabinet minister Martin Cauchon ran for the washroom at the sight of me waving a notebook in the air.

The no-contact rule eliminated all parliamentary support staff who traditionally fill in for busy bosses. Politically sensitive lobbyists or industry reps joined the no-show parade, fearing they'd be caught in a published photo with the guest of honour.

It all smacked of excessive precaution and pettiness. One conference official was upset with Clement for giving the event a pass without a doctor's note. "This is about a billion-dollar health research industry, not a political grudge match," he said.

The Mulroney speech, which opened and closed to a standing ovation, was a defiant display of bravado and vintage blarney. The beaming former prime minister acts like there are only blue skies over a 14-year political afterlife that will be re-examined in microscopic detail for cloudy behaviour.

"I was thinking about the good things about political life," Mulroney said. Pause. Grin. "I had to think hard."

There's no disputing Mulroney's mastery of the microphone, a skill that will undoubtedly surface on the witness stand for the days, if not weeks, he's in front of the inquiry.

That's undoubtedly the queasy optic that convinced Harper to put a barge pole between his cabinet and the former prime minister, even though the allegations come from a story-changing, probable deportee sitting in a Toronto jail.

Insiders insist this family feud will not break the Conservative party into Mulroney and Harper camps. The two factions will be bound together by the "discipline of power" and the pursuit of long-term government control, one cabinet minister told me.

But Harper's no-talk, no-touch edict has infuriated Mulroney, who believes he has been betrayed and found guilty despite the expected presumption of innocence.

In the long run, an internecine showdown between a proud former prime minister and the cautious current one would still seem possible. But if any illustration is needed of how quickly relationships sour (and arguably become restored) in politics, one need only refer to Thursday gala's guide.

There, on the first page, Mulroney was hailed as a "visionary" who had the "courage to adopt sound and visionary public policy" in health research.

"I am proud to say that our government carries on the legacy of prime minister Mulroney," noted this high-profile fan.

The person praising and pledging to follow this Conservative pariah? Why that would be none other than ... former friend Prime Minister Stephen Harper.

dmartin@nationalpost.com









Copyright © 2007 CanWest Interactive, a division of CanWest MediaWorks Publications, Inc.. All rights reserved.

This is from this site.
CHA stands for Canadian Health Act services.


The increase in the cost of non-CHA services has become particularly pronounced in the case of prescription drugs whose share of health care costs almost doubled, from 7 percent in 1987 to 12 percent in 2001. The disproportionate rise in prescription drug costs among all items of health care expenditures over the period 1987-2001 alone accounted for about 53 percent of the rise in the share of resources allocated to the health care sector. Since 1997, drug costs (prescription and non-prescriptions) have exceeded expenditures on physicians by a growing margin. In 2003, spending on drugs represented 16.2 per cent of the total health expenditures in the country, up from 9 per cent in 1984.

It is often argued that higher drug costs pay for themselves because they provide hospitals with more effective therapy. However, according to a recent of study of 1035 new drug applications that received approval by the Food and Drug Administration in the United States for the twelve year period from 1989 to 2000, in 85 percent of the cases the new drugs do not provide significant improvement over current therapies. According to the National Institute for Health Care Management, drug manufacturers have capitalized on perverse incentives in new patent laws and advertising regulations to flood the market with new products (known as “evergreening” in the industry). Joel Lexchin tells us that of the 455 new patented drugs introduced into Canada from 1996-2000, only 25 (just over 5%) were major improvements.

Successive Tory and Liberal administrations have rewritten patent laws and regulations extending the period of patent protection and restricting access to lower priced generic drugs. The extension of patent protection was justified on the grounds that we needed to encourage the multinational drug companies to do more of their research and development in Canada. In other words, the cost of higher drugs would be offset by the multinationals’ willingness to increase Canada’s role in the “knowledge” economy. But if these new drugs drive costs up without improving our health or saving resources, this is the equivalent of paying corporations to dig holes and fill them in again.