Greece's parliament has passed major new pharmaceutical cost-containment legislation which will require drugmakers to cover, each quarter, any overspending on the strict limits which the bill sets for the national drugs bill.
The new law - which passed on a 213-58 vote, with a number of deputies abstaining - states that overall drugs spending by Greece's social insurance funds must not exceed 2.88 billion euros for this year.
The legislation also mandates that, from April 1, clinicians must prescribe medicines from the 10 most-widely used therapeutic classes by generic name only, and from June 1 this requirement will apply to all products on Greece's positive reimbursement list. The funds will reimburse at the level of the cheapest product in each class, and any cost difference between this and the product supplied will have to be paid for by the patient.
Moreover, "inappropriate" prescribing - ie, of medicines by other than their generic name, and not of the cheapest product available - will now be classed as a criminal offence, according to local reports.
Generics currently account for just 18% of the pharmaceutical market in Greece, one of the lowest levels in the European Union (EU , and the latest measures aim to bring this up to the EU average of 50%. Health Minister Andreas Loverdos - who says he intends to slice a massive one billion euros off the nation's drug spending in a single year - has condemned a "coalition of interests" for allegedly attempting to cast doubts on the quality and safety of generics with the aim of hindering their wider uptake in Greece; however, counterfeit drugs are a significantly greater problem for Greece than for other EU nations.
The new law also seeks to save money by mandating the use of computerised prescriptions, with the imposition of a 1-euro fine on doctors for each hand-written prescription, and deregulation of pharmacy opening hours.
The legislation constitutes a requirement by the EU, the European Central Bank (ECB and the International Monetary Fund (IMF - Greece's "troika" of creditors - for agreeing a second bailout of 130 billion euros for Greece.
It is also reported that Yiannis Tounta, president of Greece's National Organisation of Medicines (EOF has been in talks with the troika concerning moves to delay the introduction into Greece of innovative new medicines until the products have been accepted for reimbursement by 8-10 other EU member states. Cancer drugs would be excluded from the proposals.
Commenting on the new legislation, analysts at IHS Global Inslght say that the requirement for pharmaceutical companies to pay back any spending above the stated limit in each quarter is "very negative." This is especially so given that many multinational and Greek drugmakers are owed considerable amounts, by the public hospitals in particular, and that the multinationals which have been paid in Greek government bonds have seen their value plummet, they note.
• A number of decrees concerning implementation of some of the major measures contained within the cost-containment legislation are expected to be announced shortly.
On February 29, a federal district court judge issued an
Order requiring that Cardinal Health, Inc. comply with an Immediate Suspension Order ("ISO" issued by the Drug Enforcement Administration ("DEA" . The court previously granted a temporary restraining order delaying Cardinal's compliance with the ISO, pending a decision on a preliminary injunction requested by Cardinal. However, the Court denied this preliminary injunction in its Order. Cardinal
appealed this decision on the same day as the court's Order.
Partially at issue in this dispute is the question of who is responsible for stopping diversion, a form of illegal sales of controlled drug substances. Diversion is distributing controlled drug substances to an entity without a valid DEA registration. In this case, diversion of the prescription pain killer oxycodone allegedly took place at pharmacies supplied by Cardinal's Lakeland, Florida distribution facility. Cardinal states that it has a system in place to stop diversion and that it is ready and willing to suspend shipments to any pharmacy that the DEA identifies as likely to be engaged in diversion. The DEA, however, states that the Lakeland facility has a continuing, affirmative obligation to police its retail customers to ensure that the controlled drug substances it provides are not being unlawfully diverted--and the Lakeland facility fell short of its legal and contractual obligations.
According to a
Complaint filed by Cardinal, the ISO requires the Lakeland facility to immediately halt shipments of all controlled drug substances to about 2,700 pharmacies, hospitals, and other customers to prevent alleged imminent danger to the public health or safety. Notably, only Cardinal's Lakeland facility is subject to the ISO. The DEA, however, does not allege that Cardinal itself distributed controlled drug substances to any entity not permitted to purchase them. Instead, the ISO was issued because four pharmacies that were supplied by the Lakeland facility have allegedly distributed oxycodone for illegitimate uses.
Bayer Healthcare currently faces about 11,300
Yaz lawsuits filed by women who claim that Yaz causes serious injuries. The pharmaceutical giant agreed to settle about 70 of these lawsuits.
In its 2011 Annual Financial Report, the company informed investors it has have settled a number of cases and may continue to settle case by case.
On December 8, 2011, a panel of advisors for the U.S. Food and Drug Administration met to discuss the benefits of birth contraceptives
Yaz and Yasmin®. In a vote of 15 to 11, the agency determined that the benefits of the pills outweighed the risks.
A study conducted by Canada Health officials compared what are considered “new generation” birth control pills, which includes Yaz and Yasmin, to traditional birth control pills. Results of the study revealed that Yaz and Yasmin pose a higher risk for blood clots than traditional pills.
Yaz was introduced by Bayer in 2006. The oral contraceptive generated sales of $781 million for the company in 2009 but those sales have since dropped to $374 million due to emerging safety concerns.
Women who have taken Bayer’s oral contraceptives claim to have suffered adverse side effects such as stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease, and even death.
Yaz, Yasmin, and other new generation birth control pills contain an active ingredient known as drospirenone which is not found in traditional birth control pills. The FDA conducted a study examining more than 800,000 women. The study compared pills containing drospirenone to pills not containing drospirenone. Results revealed that women on pills containing drospirenone face a 74% higher risk for developing blood clots than women taking traditional pills.
Prior to the settlement of
Yaz lawsuits, mediation was ordered between all parties involved. Judge Hendon, who is presiding over all Yaz lawsuits, issued an order which indefinitely continued the start of the first trial. The order mandated both parties to engage in settlement negotiations in good faith.
GlaxoSmithKline Plc (GSK is adding new products in
China and hiring “a few hundred” more salespeople to promote them, betting that health-care reforms will widen access to drugs and make up for state-mandated price cuts.
The drugmaker will expand its sales force of 4,000 in China this year after hiring more than 700 people in 2011, Chief Executive Officer
Andrew Witty said today in Beijing.
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