GLOBAL Safety Issues

Contributed by:

Denise Myshko

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BY DENISE MYSHKO

The European Commission has proposed a series of efforts, commonly referred to as the Pharmaceutical Package, which contains three important initiatives: a proposal for a directive on how to modernize pharmacovigilance; a proposal to address counterfeit medicines; and a directive on the future direction of the supply of health information to patients. The reform package is essentially a watered-down version of the reforms that were originally proposed by the EU Industry Commissioner Günter Verheugen, meaning that it is less pro-industry than first thought, says Mitra Thompson, senior analyst, at IHS Global Insight. “The main blow to brand-name pharma companies is that the promised ban on drug repackaging has been shelved,” she says. “The industry had been hoping the ban would crack down on competition from parallel traders. A positive impact on the industry will be more flexibility in the way that producers can approach consumers with information, thanks to the loosening of advertising products in specialist Internet and print media. Manufacturers also will have to develop closer ties with their wholesalers and suppliers and ensure that they only work with wholesalers that are on the European Medicines Agency’s approved list.” Raymond Panas, Ph.D., director of international clinical development at Sucampo Pharmaceuticals, says the modernization of pharmacovigilance models is gaining in popularity around the globe. “Having a centralized database to track and evaluate postmarketing events provides a greater opportunity for signal detection of events not seen during clinical development,” he says. “Furthermore, the broader patient population could help determine if trends are truly global or isolated to certain patient groups. Counterfeit products are a problem and can be an issue in the emerging markets. This issue isn’t really going to be resolved until local agencies step up and address the problem within their borders. Unfortunately, counterfeit products can result in serious consequences for the unsuspecting patient. With growing technologies and the broader use of the Internet, product information may become more difficult to control.” But Bruce Garrett, M.D., president and CEO of Global Research Services, says pharmacovigilance needs more standardization in Europe. “Every European country still has its own regulatory authority, and the reporting mechanisms are not universal,” he says. “This process needs to be simplified, easy to work with, and accepted by all EU and non-EU countries. The trafficking in counterfeit medicines is a border inspection issue. More inspection needs to be done within suspect countries. More information provided to patients can only improve the research process. The more patients know, the more they will understand the need to improve upon currently available treatments and hopefully there will be a greater willingness to be a part of the research process.” Carleen Kelly, president of Surge Worldwide Healthcare Communications, says the European initiatives are important from a safety perspective, strengthening transparency and communications about adverse events, and for ensuring that patients receive the actual medications prescribed. “Companies taking the lead in implementation may be perceived positively,” she says. “The patient information initiative may slightly relax existing regulations and provide opportunities for better dialogues with physicians.” Patricia Lovell Hoare, executive VP of regulatory affairs at Chiltern, says the pharmacovigilance procedures in place within the European Community for postmarketed drugs are the most stringent in the world. “The competent authorities and safety surveillance groups are proactive and vigilant in monitoring changes in the risk profile of marketed products while possessing the authority, vested in them by government, to take measures that will ensure compliance,” she says. “While more information will be available to patients via the media, direct advertising of prescription drugs will remain banned. The provision of additional data to patients — suitably phrased — can only be classified as a positive step in enabling patients to be better informed in managing their conditions and to be fully aware of side effects and contraindications.” F Global regulatory trends • Globally, the regulation of pharmaceutical prices has increased in recent years. • In most cases, regulation has reduced pharmaceutical revenue. • Regulatory approaches that reduce pharmaceutical revenue may generate modest consumer savings in the best cases, but risk much larger costs as decreased innovation leads to reductions in life expectancy. • Approaches that reduce consumer costs (by cutting copayments) without affecting pharmaceutical revenue are more likely to benefit both current and future generations of consumers. Source: Rand Corp. For more information, visit rand.org. drivers of and constraints on the applicability of evidence-based medicine Drivers Constraints Epidemiological and demographic changes Tailor-made medicine High cost of biogenerics and biotechnology products Pressure on the government to keep the status quo Need for pharmaceutical cost-containment within all types of healthcare systems Lack of public resources for assessment of cost-effectiveness of medical treatments and pharmaceuticals Need to manage large number of insurance claims Practical difficulties in following guidelines, including information overload Ease of applying standardized procedures through advanced IT Physicians’ reluctance in complying with guidelines Drug lifecycle management Sheer volume of evidence Other countries simply following suit of largest global healthcare and pharmaceutical markets U.S. healthcare system being substantially different from European models Source: Arrowhead Publishers. For more information, visit arrowheadpublishers.com. approved biosimilar products Approval Time Biosimilar Product Name Compound Manufacturer January 2006 Omnitrop somatropine (human growth hormone) Sandoz May 2006 Valtropin somatropine (human growth hormone) BioPartners August 2007 Binocrit* epoetin alfa Sandoz August 2007 Epoetin Alfa Hexal* epoetin alfa Hexal August 2007 Abseamed* epoetin alfa Medice Arzneimittel Pütter Gmbh December 2007 Silapo epoetin zeta Stada December 2007 Retacrit epoetin zeta Hospira September 2008 Ratiograstim# filgrastim (granulocyte colony-stimulating factor (G-CSF)) Ratiopharm September 2008 Filgrastim ratiopharm# filgrastim (granulocyte colony-stimulating factor (G-CSF)) Ratiopharm September 2008 Tevagrastim# filgrastim (granulocyte colony-stimulating factor (G-CSF)) Teva September 2008 Biograstim# filgrastim (granulocyte colony-stimulating factor (G-CSF)) CT Arzneimittel * Approvals based on one development. # Final approval came after the CHMP re-issued a positive opinion for approval in July 2008. The CHMP had originally issued a positive opinion in February 2008, but was asked to re-examine the data by the European Commission and to evaluate whether data from a biosimilar filgrastim, marketed as Grasalva in Lithuania by Sicor Biotech UAB (part of Teva) was relevant for the assessment of the marketing authorization applications for these products. Source: IHS Global Insight. For more information, visit ihsglobalinsight.com. Patricia Lovell Hoare • Chiltern Dr. Raymond PanaS • Sucampo Pharmaceuticals Having a centralized database to track and evaluate postmarketing events provides a greater opportunity for signal detection of events not seen during clinical development. Patricia Lovell Hoare • Chiltern While more information will be available to patients via the media, direct advertising of prescription drugs will remain banned in Europe.

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