Eyes On Europe - Pharmaceutical Executive

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Eyes On Europe
Intelligent surveillance can help pharma companies act before local crises damage global brands.


Pharmaceutical Executive


Also see Under Review
Despite recent EC legislation, there is still room for negotiation on several issues critical to pharma:
12

Surprises may be good for birthday parties, but when it comes to pharma marketing, global companies with US headquarters need to know what to expect from European markets. Whether they face stiff competition for blockbuster products; are involved in acquisitions, mergers, or litigation; or are monitoring the European Commission's (EC) decision making process, global pharma marketers must be aware of negative buzz that might affect their global brands. Otherwise, cases such as the following can result:

  • A multinational company with US headquarters was blindsided several months ago by an attack on its reputation that began as a small article in a local German newspaper.
  • A French affiliate thought it had mitigated a published attack on a global brand's safety profile, but the internet carried the news to other markets. Now the US-based global brand manager faces a larger crisis.
  • A global brand manager was never informed that Sweden excludes "lifestyle" products from its national formulary. Now several other countries may follow suit, and brand managers marketing those treatments in other European countries must play catch-up to protect their local brands.

Generally, European-based marketing and public affairs executives effectively monitor local policy, defend local market share, and protect their local corporate image. However, they can't be expected to flag every issue brewing in the countries around them. Systematic intelligence gathering can help executives from US-based corporate headquarters keep abreast of local issues throughout Europe, assess them from a macro perspective, and mobilize strategies to deal with problems that may adversely affect their products-before they escalate into crises.

This article describes how companies can gather timely intelligence by giving corporate executives and their public relations agency partners the resources necessary for global surveillance.

First Signs of Trouble Global crises often germinate on the local level through the activities of competitors, national or local politicians, physician thought leaders, and consumer and environmental advocacy groups that wield more power and prestige than their US counterparts. The first signs of an emerging global problem usually appear-both off- and online-in local business, consumer, or medical media.

In one case, the German press accused a global pharma company of wielding US political power to damage a popular German pharma company. That not only created a hostile environment for new product launches there but also had the potential to malign the global pharma player's reputation in an entire therapeutic category. By the time its US headquarters knew what was happening, the damage was done.

That scenario can occur in multiple languages, so monitoring in English alone is insufficient. To avoid surprises, pharma companies need intelligence experts with a grasp of politics and marketing in each key European market. Information gathered across national boundaries and within specific markets enables global executives to take decisive action during the early phases of a gathering storm. Superior political/marketing intelligence and analysis-on a local level-helps companies sniff out whether lawsuits, discontent among third-party groups, seemingly harmless attacks from competitors, or new policies have the potential to derail them globally.

According to Jeff Winton, Pharmacia's vice president of global public relations, intelligence gathering is important, but only as a means to an end.

In his experience, many companies conduct surveillance but leave out critical analysis.

"The real endpoint must be global scenario planning and issues management based on all collected information," he says. "Planning far in advance of any issue and anticipating any and all issues must be a key part of any program. To protect yourself against crises, you need to have a global process in place that will successfully use the material gathered."

Managing Data Overload Pharma companies need a seamless intelligence gathering system that monitors discussions in every language at every level-local, national, and Pan-European-and from various sources, including word-of-mouth and digital as well as traditional media. Yet, managing intelligence gleaned from Europe is virtually impossible to do solely from the United States. To gather and analyze the information in a timely fashion, US-based pharma companies and their public affairs leaders must work with agency partners that have

  • offices in all key markets-preferably wholly owned rather than loose affiliates-staffed by executives with political/marketing intelligence and analysis capabilities, as well as access to the most up-to-date and comprehensive news sources. At a minimum, those include the Observer in Germany, Argus Media in Switzerland, Knippsel Info in the Netherlands, and Auxipress in Belgium.
  • a lead European office that collects individual country reports issued in different languages. It can provide a cogent overview and develop an overall intelligence report assessing implications from business, corporate reputation, and political perspectives.
  • a US-based headquarters that partners with the company's global public affairs executives to develop strategies focused on protecting global brands.
  • the ability to deliver timely information and analyses-as early as 9 a.m. US Eastern Standard Time-including an executive summary describing how the day's events throughout Europe may affect a company's business. Ideally, it should be delivered to senior management in an encrypted e-mail message that can be decoded and shared. Each document should include country-specific breakdowns containing summaries of all news sources, including their political leanings, circulation, and reporters' tone or bias-all in English.

"The agency partners closely with a seasoned issues management team at corporate headquarters, which manages all information that may affect the company's brands or reputation," says Mari Mansfield, global public relations manager of psychiatric products at GlaxoSmithKline. "Corporate PR executives not only create and oversee a well orchestrated plan of action, they ensure that all communications reflect the company's long-term vision."


Also see Under Review
Despite recent EC legislation, there is still room for negotiation on several issues critical to pharma:
12

Related Article


Under Review
Despite recent EC legislation, there is still room for negotiation on several issues critical to pharma:

Information and advertising versus patient protection. Although existing law prohibits direct advertising of prescription medicines to the public, the European Commission is advocating legislation that would allow the pharma industry to disseminate information about treatments for three conditions: asthma, HIV, and diabetes. After five years, the commis-sioners are expected to release a report evaluating the results. The Commission argues that the public wants more information and can easily get it on the internet. It says it's preferable to provide pharma information vetted by the European Agency for the Evaluation of Medicinal Products (EMEA) rather than to let con-sumers find unregulated-and potentially inaccurate-information on their own.

Yet some consumer and patient groups, such as the European Consumer Asso-ciation, have increased opposition to the EC's proposal. They view it as a step toward US-style direct-to-consumer advertising and claim it is an industry-inspired attempt to boost sales rather than help patients. They argue that implementation will lead to overconsumption of medicines and higher healthcare costs.

Intellectual property vs generics. The commission must balance protection of companies' intellectual property rights with patients' right to access lower-priced generics. That pits the two against each other: Pharma favors the Commission's proposals relevant to its business, but consumer groups and generics makers are working toward more efficient ways to notify consumers and doctors about the availability and price of generics.

Centralized procedure versus mutual recognition. Within the European Union, there are two routes for authorizing medicinal products:

  1. Companies apply directly to EMEA, leading to EU-wide marketing authorization by the Commission. They must use that procedure for all biotech products, but they are not required to do so for other innovative medicines.
  2. Companies apply to one or more individual EU member states of their choice, and other national marketing authorizations recognize the approval, known as mutual recognition. When that is not possible, EMEA prepares a binding arbitration. Single national authorizations are still available for pharmaceuticals to be marketed within only one EU member state.

The industry wants to keep both systems because, for some products, the centralized procedure is too slow. It also worries that supporting the centralized procedure will weaken assessment skills among nationally based evaluating bodies. The 15 EU mem-ber states are likely to agree and may fight to keep roles for their own regulatory bodies. They are not only reluctant to cede their powers to the European Union; they are loath to lose local authorization expertise.

Pharmacovigilance and fast-track registration. The Commission wants to eliminate the obligatory five-year re-evaluation for marketing authorization renewal and upgrade EMEA's monitoring of side effects. Member states will be obliged to provide side-effect information for a database with direct links to EMEA and the relevant regulatory authorities in the other member states.

That stronger pharmacovigilance should also guarantee better health protection, especially with the fast-track registration procedures the Commission proposes. Again, consumer associations object to those proposals because they see no need for a fast-track procedure, except when life-threatening diseases are involved. They want pharmacovigilance procedures to include greater involvement of patients and health professionals.

Pediatric medicines. In December 2000, the Council of Health Ministers invited the Commission to "make appropriate proposals as soon as possible in the form of incentives, regulatory measures, or other supporting measures in respect of clinical research and development, taking into account the ethical aspects of clinical trials on children." Major issues involved in that legislative charge will be a longer period of intellectual property protection to reward work on innovative pediatric medicines and marketing authorization that would extend patent protection to new pediatric uses of older products.

Antimicrobial resistance. In November 2001, the Commission encouraged member states to address the growing threat of antimicrobial resistance. The resulting recommendation charges the Commission to support member states' efforts to moni-tor and control communicable diseases. Future actions will focus on prevention, diagnostics research, public awareness, monitoring of prescribing habits, and establishing systems to ensure good marketing practices. Some countries-Belgium and France among them-have already launched public education cam-paigns asking for more appropriate use of antibiotics. Others plan to do the same.

Biotechnology. The Commission, in close cooperation with the European Council and Parliament, will determine the priorities of an action plan adopted in January 2002. Major biotech issues concern intellectual properties, legislative proposals for tracing and labeling genetically modified organ-isms, and a proposal regarding cell and tissue implants.

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