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Pharmacapsules @ Gowlings |
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| May 29, 2008 - Volume 7, Number 6 | Executive Editor: Jennifer Wilkie, Chantal Saunders | ||
In this issue
MPs Support Orphan Drug Proposal
Canada is now one step closer to a national orphan drug plan after the House of Commons recently voted in favour of a motion compelling the government to consider a policy to help those suffering from orphan diseases and facing unequal access to medicines. Orphan diseases are commonly defined as those affecting only one in 2,000 Canadians. Orphan drugs are generally very expensive, at times costing up to $400,000 a year. The private member's motion, M-426, was passed on Wednesday May 7, 2008. This motion will require the government to: (1) examine options for defining rare medical conditions; (2) consider creating a fund to improve access to treatments and (3) explore methods to encourage drug research. The motion was brought forward by Liberal MP Don Bell. This is a cause close to Mr. Bell's heart as his grandson, Dylan Hunter Bell, died on July 14, 2007 at the age of 12 after suffering from pulmonary hypertension, an orphan disease, having required continual drug treatment.
For more information, please see:
Annual Drug Spending in Canada
The Canadian Institute for Health Information recently released its annual report entitled Drug Expenditure in Canada, 1985 to 2007. It reveals that spending on prescription and non-prescription drugs totalled $27 billion last year, compared to $25 billion in 2006. It is estimated that 84% of the total spending on drugs in 2007 was for prescription drugs. It is said that the reason for this increase is due to the aging population, increased use of drug therapies and new drugs entering the market. The report also shows that drug spending varies widely from province to province due to varying provincial drug programs, disease patterns and demographics.
For more information, please see:
FDA Clinical Trial Regulations
As part of the FDA's and the HHS Office for Human Research Protections' initiative of issuing regulations instead of guidances for clinical trials, they are working on a final rule for registering institutional review boards (IRBs). Existing FDA regulations do not take into account all the different types of organizations involved in conducting clinical trials and also fail to take account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms.
For more information, please see:
FDA Clinical Trial Regulations
On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market. The new computerized "Sentinel System" will assist the FDA in monitoring existing data sources such as the U.S. government's Medicare health insurance plan. Health and Human Services Secretary Mike Leavitt told reporters that, "We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market." In the past, the FDA relied on mandatory reports of side effects by manufacturers and voluntary reports by physicians and patients. Under the new proposal, data will be gathered from private insurer claims, hospital records, and Medicare. The FDA expects that the large sample populations involved will allow it to rapidly identify risks that appear when products move from small clinical trials to wider use in the marketplace. More than 25 million patients receive prescription drug care under Medicare alone. It is not clear how soon the Sentinel System will be implemented.
For more information, please see:
Emerging Nanotechnologies Raises Concerns
A recent study reported in the scientific journal, Nature Technology, has revealed concerns over the use of nanotubes because their qualities mimic the toxic qualities of asbestos. The structure of nanotubes, which are currently available for sale, endows them with powerful physical properties, such as strength greater than that of steel, and as such, carbon nanotubes are being explored for a wide range of uses in electronics and medicine. Some potential applications involve coating the nanotubes in other substances, which could blunt any toxic effects. However, British and U.S. based scientists have reported experiments, which find that longer threads of nanotubes injected into the lining of mice stomachs provoke inflammation and lesions. Researchers have acknowledge that their findings have limitations and have called for more study into the efficacy of nanotechnology. These findings support earlier research from Japan which showed that mice injected with carbon nanotubes developed mesothelioma. It is unclear what causes these effects.
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EU Expands Antitrust Inquiry of Drug Companies
European antitrust regulators are continuing their inquiry into industry and corporate practices in the European pharmaceutical market. The inquiry was initiated as a result of the declining number of new drugs reaching the market, as well as perceived delays in entry of generic drugs as compared to other jurisdictions such as the U.S. The inquiry has included questioning or raiding approximately 100 companies, including some of Europe's largest pharmaceutical manufacturers, as well as various medical organizations. Investigators are also investigating whether generic companies have accepted payments from brand-name manufacturers during the course of patent litigation, mirroring earlier antitrust decisions in the U.S. The competition commissioner has indicated that it is still far too early to draw preliminary conclusions from the sector query.
For more information, please see:
Proposed Amended Drug Regulations Not Popular With Provinces
The provincial health ministries are unhappy with proposed federal regulations which reaffirm transitional provisions enacted in 2006. A decision last year however had the effect of reading down this legislation thus generic manufacturers were effectively able to argue that they can ignore certain patents on the patent register. The legislation introduced at the end of April, was for the stated intention of restoring the certainty and the intention of Parliament in requiring these patents to be addressed. Provinces complain that this may mean that certain products will not become genericized as quickly as it would if the Court's decision continued to apply with consequentially higher prices for drugs to be paid for by the provinces. While the B.C. Health Minister had written to Health Canada requesting additional time to make submissions and complaining about the abbreviated time that had been provided, a communications officer at Industry Canada indicated that "a longer consultation period was not warranted since the regulatory proposal merely reaffirms a policy measure dating from 2006 that was the subject of extensive consultations at the time.".
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Some Canadian Biotech Companies Unhappy With Length of FDA Approval Process
Canadian biotech companies amongst other countries' companies are reported recently to have been indicating their unhappiness with the speed with which the FDA is approving new drugs. In particular, certain Canadian companies have been delayed an entry to U.S. markets for months due to delays in obtaining approvals. Such delays effect stock prices and business dealings relating to anticipated approval time frames. The FDA has indicated that a shrinking staff and dwindling funds have resulted in hold-ups in approving new products.
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New Global Initiative of the World Health Organization (WHO)
Recently, delegates at the annual Assembly of the WHO have backed a new initiative which aims to promote new approaches to pharmaceutical R&D and enhance access to medicines around the world. The 61st Assembly, which reportedly had a record 2,704 delegates from 190 nations attending have approved a global strategy aimed to provide a framework for enhancing essential R&D especially with relevance to diseases impacting on developing countries, also focussing on the major current threats to health such as cancer and heart disease and making R&D finances in developing countries sustainable. The strategy also calls for a finalization of a plan to provide drug makers with greater incentives in such areas of research and making advances affordable and accessible in developing countries.
For more information, please see:
Bisphenol A Concerns Continue
In a recent article it is reported that not only baby bottles and water bottles are cause for concern with bisphenol A but also canned foods. According to recent testing conducted for various news agencies, the amounts of bisphenol A have been found in higher amounts than even those amounts for the bottles previously looked at. Health Canada has indicated that none of the amounts tested exceed the regulatory limits and that Health Canada is not concerned about these levels for older children and adults saying that the risk is negligible. However, the fact that food makers may start reformulating cans without this chemical, they have indicated they are committed to working with the industry to investigate possible safe replacements for these cans containing epoxy based linings.
For more information, please see:
Recent Cases Apotex v. Sanofi-Aventis; Appeal of Motion of to Strike; Infringement Proceeding; May 13, 2008; ramipril The Court of Appeal upheld the order of trial judge striking portions of the counterclaim relating to improper conduct. However, the Court of Appeal found that the reasons of the trial judge were unsupportable. The Court of Appeal struck the improper conduct pleading as there was no relationship between the alleged improper conduct and the equitable relief sought by the parties. The Court also considered and approved of the Trial Division's reasoning in staying part of the counterclaim that was duplicative. The full text of the decision can be found at: Abbott Laboratories v. Canada (Minister of Health); Mandamus Proceeding; May 20, 2008; lansoprazole The Court of Appeal upheld the decision of the trial judge refusing to grant an order prohibiting the Minister from issuing a NOC to a generic company without requiring them to address two patents on the Patent Register. The Court held that this decision would not preclude Abbott from challenging such a decision in the future should the Minister issue the NOC. However, the Federal Court will not grant an order that simply requires the Minister to do what the NOC Regulations require. Furthermore, granting the order requested by Abbott would not be fair to any other generic manufacturers who filed an ANDS prior to the listing of the two patents at issue on Patent Register, as they would not have an opportunity to be heard. The full text of the decision can be found at: Nycomed v. Sandoz; motion under s. 6(5)(b) of the NOC Regulations; April 28, 2008; pantoprazole The Court dismissed a motion by the generic manufacturer to dismiss the proceeding on the basis of abuse of process. The Court found that there had been no final determination as to the eligibility of listing of one of the patents at issue. Furthermore, the Court held that there had been no previous decisions on the issue of whether there were any claims to the medicine itself or the use of the medicine in the patent. The Court also refused to grant the motion to dismiss the non-infringement allegations on the basis of abuse of process. The Court found that Sandoz had failed to meet its burden of establishing by evidence or cogent argument that there could be no evidence whatsoever on the merits from which infringement could be found. The Court awarded costs to Nycomed at the high end of Column V of the Tariff forthwith and in any event of the cause as it was successful in opposing the motion and at least two of the grounds raised were ill-considered, ill-founded and should not have been raised. These grounds unnecessarily wasted the Court's time and the efforts of Nycomed to proceed with the merits of the case. The full text of the decision can be found at: Ranbaxy Laboratories Limited v. Pfizer Canada; Motion to Intervene; April 15, 2008; atorvastatin The Trial Division had issued an order of prohibition on one patent and denied prohibition on another patent. Both parties appealed. Apotex then brought the within motion for leave to intervene in that appeal. The Court of Appeal dismissed Apotex' motion. Apotex wanted to intervene on the basis that it disagreed with the Trial Judge's application of the Saccharin doctrine in Canada. Apotex' argument was that Ranbaxy's position on the appeal was extremely narrow and would not adequately represent its own position in another proceeding where the issue of the Saccharin doctrine was also an issue. The Court held that it was far from clear that a decision in this case between two parties unrelated to Apotex would finally resolve the issue in an infringement action between Apotex and another party. The Court of Appeal upheld its previous decision that it is inappropriate to rely on NOC proceedings as setting binding precedent in controversial or uncertain questions in patent law. Furthermore, by allowing Apotex to intervene, the Court would need to allow the other party to the infringement proceeding to intervene as well. This would undoubtedly complicate and delay the appeal. Furthermore, Apotex had known about the decision under appeal for several months yet waited until the eve of its trial to bring the motion to intervene. The full text of the decision can be found at: GlaxoSmithKline v. Pharmascience; 55.2 Proceeding on Merits; May 9, 2008; valacyclovir The Federal Court refused the prohibit application at issue in this case. The Court upheld the validity of the patent on the basis of obviousness and anticipation. However, the Court held that GSK had not met the burden of establishing that its patent was a valid selection in terms of utility as neither the patent nor the evidence of the expert witnesses was sufficient to establish an advantage of the selected compound over the genus from which it was chosen. Specifically, the Court found that the fact that patent showed testing of the selected compound against the three compounds from the genus of millions was not enough to show whether that "same advantage would exist vis-à-vis a few, some, many, most or all of the other compounds claimed" by the previous patent. It was necessary to have a sound prediction establishing the special advantage. The full text of the decision can be found at: |
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