One World, One Voice

The regulatory harmonization that started in the early 1990s has benefited the pharma industry in a host of ways. Companies can now limit the length and expense of global clinical development programs by conducting large multinational clinical studies at key centers worldwide. Key opinion leaders around the world gain similar product experience with a new molecule months before launch. Most important, the harmonization allows companies to submit product applications that follow the Common Technical Document guidelines and therefore are similar in content and format across all major pharma markets. As a result, new products have indications and package inserts that vary little between countries.

This evolution is very positive for pharma marketers, who can now develop global brands free of the constraints of multiple labels and indications. In addition, better sharing of breakthrough research-through bigger but fewer international scientific conferences and a handful of prime medical journals-has led to an alignment of treatment guidelines in almost all disease areas, making it easier to globalize product information.

Yet global marketing departments are still not widespread among pharma and top-tier biotech companies. Pharma companies are usually dealing with the hurdles of historical structures, in which key affiliates, reporting to the CEO or head of business, are reluctant to give up their autonomy and influence. And biotechs like Amgen, Genentech, or MedImmune are often too focused on their local market or are not truly global, having sold overseas rights to their lead products and given up marketing control. And whatever the reasons, the global marketing units that do exist are not always as efficient as could be expected. They often don't have the full set of responsibilities needed to be effective and successful. Their role may be limited to the management of early stage products, while control of the launch and postmarketing phase is left to independent, local country-specific departments. Even when a global unit creates global brand strategies, implementation is too often left to the local groups.

Pros + Cons

On the Plus Side

A global marketing unit can quickly increase product sales and reduce marketing expenses, but only if its role is understood and accepted within the company. The role of global marketing can be characterized by its three broad functions:

• define product vision/strategies

• guide and support their implementation worldwide

• maximize products' commercial and therapeutic value.

In addition, global marketers provide guidance, oversight, and collaborative support to local marketers and product managers to create unified brands and to ensure that marketing strategies are consistently applied.

But before a company establishes such a department, it should understand the possible benefits and limitations. Following are several poten-tial advantages in developing global marketing programs.

Cost savings. Developing one set of brand elements, core promotional materials, and core training manuals in particular, reduces costs at the local country level. Instead of bearing full development costs (multiplied by the number of countries involved), local marketing departments need only budget for the adaptation of core materials.

Cost savings may also be realized by running global market research studies for positioning, forecasting, message, and concept testing or tracking. The use of a single questionnaire, translated and printed in multiple languages, and one vendor for each study instead of multiple efforts translates into lower market research expenses. Likewise, global promotional or educational programs, such as symposium spin-offs, can result in production efficiencies that decrease per-unit costs. Effective global marketing departments can offset the need for, and therefore the cost of, creating multiple regional marketing groups.

Internal efficiency. When departments such as clinical research, preclinical, regulatory affairs, and manufacturing have only one contact from global marketing, they do not have to deal with conflicting feedback or information overload from multiple marketing groups. Through a global marketing unit, all marketing groups can be represented and heard instead of only the most vocal or influential group. Global marketing departments reflect common needs or issues across the board. They can spend time educating, debating with R&D, and nurturing relationships built on trust, making the exchange of information more frequent and effective.

Key Relationships : Global marketing departments can- and should- exchange information with key players in the organization

Consistency in branding. Marketers cannot attain global brand identity without achieving consistency over an extended period of time and across multiple markets. Maintaining a common marketing platform around the world helps maintain one unique recognizable brand and company image. This is particularly important for disease areas in which national practice guidelines are aligned and scientific information flows freely across national boundaries. Branding consistency is impossible unless a brand's core message is communicated by all company representatives inside and outside the company, from sales reps to upper management.

Marketing efficiency. A marketing program that has worked particularly well in one country can be quickly identified, analyzed, and implemented in other countries. For example, Syntex translated and adapted a successful locally produced brochure on cytomegalovirus (CMV) infection for use in other countries, and Gilead used an Australian pricing dossier as a template for several European countries. By making country-by-country comparisons, global marketing departments can document what works best and help disseminate best marketing practices. Similarly, such units can systematically gather, analyze, and disseminate competitive intelligence quickly and efficiently to any market in the world.

Simpler coordination/greater control. By being close to the information source for clinical, preclinical, and manufacturing data, global marketers know more about the compound than local marketers and are best able to communicate how to effectively promote it. That knowledge base includes scientific data, product attributes, market research, pricing, positioning, branding elements, advertising, and sales support materials. However, the advantage necessitates two- to three-year minimum personnel assignments and a focus on internal promotion rather than on external hires. Branding guidelines and scientific and training brochures developed by the global marketing team become important tools for local marketing managers and help them project a uniform brand message to their counterparts in other countries.

The Challenges

Global marketing may encounter some difficulties, most of which involve cultural and regulatory differences between countries. Companies must understand regional differences so they can determine the boundaries of global marketing programs.

Customer needs and usage patterns. Although regulatory harmonization and increased similarities in local prescription guidelines have minimized some differences in cultural values, economic development, and usage patterns, market idiosyncrasies will continue to exist. In fact, market differences may be more acute in some disease areas-such as oncology-than in others. Taking this market as an example, many older oncology products are not available across all markets. Treatment guidelines often vary because they are based on local experience. And cultural differences, such as being more or less aggressive in treatment approach, further differentiate conventional oncology practices across borders. Global marketers must be familiar with such variations to implement strategies at the local country level or to make difficult corporate recommendations, such as not launching in one particular country.

Product development. Although these issues are less common, they may still exist for older products or in poorly defined disease areas. For example, products may be at different stages of their lifecycle in different countries, indications can vary, or some product line extensions may not be available in some markets. AmBisome, an IV antifungal first marketed in 1991 by NeXstar, has 12 first-line indications and six second-line indications, none of which is approved in all key countries where it is marketed. Fortunately, this situation rarely occurs with new products.

Regulatory and legal environment. Diverse regulatory challenges exist in different countries. In general, regulatory guidelines surrounding promotional activities are more stringent in the United States than they are in other countries. In the United States, sales aids are typically submitted to FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) for review (although it is not mandatory) and must be approved by DDMAC if they carry a black box warning label.

In other countries, sales aids are less regulated, leaving more flexibility in the interpretation of clinical data and the development of product claims. In many European countries, it is customary for companies to sponsor physicians to attend conferences, a practice that is no longer allowed in the United States. On the other hand, direct-to-consumer advertising is not allowed in Europe and most other developed markets, although it is widely used in the United States. These differences require some flexibility in the local application of global marketing and promotional guidelines.

Global promotional elements, such as visual aids, should include extensive data and alternatives, making it easy for local marketing departments to adapt materials to their own local regulatory guidelines without changing key brand messages. For example, both Viread (tenofovir) and Hepsera (adefovir dipivoxil) global visual aids included scientific data (such as virology or preclinical data) that Gilead marketers knew would not be allowed in some countries but would be strong selling points in others.

Critics often claim that global marketing programs ignore fundamental differences across countries and cultures. But these differences are limited, and a good global marketing program will take them into account. Companies should not try to make programs fit all markets and regulatory requirements. If they do, they will end up with conservative plans that are largely ineffective. Instead, global marketing teams must be creative, yet understand that there may be limitations to how the plan will be implemented in some countries.

Make It Work

To be effective, global marketing departments must oversee the development and management of the company's brands from very early in the clinical program (Phase I) to long after the product has been launched in all key markets (ideally until patent expiration). And company leaders must clearly communicate global marketing objectives to the entire organization. Several other parameters are also critical to the success of a global marketing department.

Teamwork. Companies cannot expect global marketing strategies to be effective without constant input and feedback from local markets. Too often global marketers involve local markets late in the process, resulting in rigid, inadequate campaigns and resistance from local marketing teams.

The attempt to enforce an inadequate campaign will often result in having local marketers simply discard it and replace it with one of their own. To avoid such mistakes, the global marketing department should create product teams early in the development process, involving managers from at least the top markets. The product team is responsible for ensuring that global strategies and programs can ultimately be implemented locally. The team can also be an excellent sounding board and a source of useful information about various marketing aspects such as local competition, market dynamics, and market needs.

The product team should meet regularly and at every important step of the marketing development process throughout the life of the product. Team meetings should leave enough time for feedback, local presentations, and discussion. Too often these meetings are used to download information but do not leave enough time for constructive criticism or brainstorming sessions. To strengthen the team and limit frustration, it is important to foster healthy debates and give each local manager a chance to express an opinion. In addition, global marketers should visit local markets frequently. This allows quality time for local feedback and gives the global marketer an opportunity to meet with other important members of the local company, including those from medical, regulatory, and sales.

Open and frequent communication. New clinical data that may affect product strategy must be quickly communicated to local managers with an explanation of the potential implications. In some cases, project team meeting minutes are a good way to communicate important information, beyond just clinical data. Similarly, the global team should ask local managers for feedback (and give them enough time to react) whenever a new market research study is planned.

Local attendance during market testing is also a good idea. It involves and educates the local manager and has the added benefit of providing quick feedback to the global manager. Indeed, any gathering is an opportunity to share information. For example, international conferences can be a good setting for inexpensive two-hour informational meetings or even one-on-one discussions between global and local product managers.

Training. For global marketing strategies to be correctly implemented at the local level, companies must consistently train local managers so that they understand the "whys" and "hows" behind global strategies. They must be given a road map and a set of guidelines that they helped design. Training should be ongoing and should cover products, markets, and marketing. Documents such as global marketing plans or branding guidebooks can serve as useful training elements if they are detailed and designed to give clear guidelines. But simply distributing them is not enough; global marketers must also review and explain.

Indeed, global marketers should hold yearly training meetings for local product managers and should seek help from members of other functional areas such as manufacturing, clinical, and regulatory to strengthen the quality of the training. External participants can also include advertising and medical education agencies. Clinical data, ongoing studies, regulatory guidelines, market data, marketing strat- egies, brand elements, and promotional and educational programs should all be reviewed during training sessions.

Leadership. Global marketers must have the ability to define a vision for the company's products and motivate people to embrace that vision. They will not only have to persuade local marketing managers but also company management, clinical research, manufacturing, and other functions.

At Gilead, frequent meetings were held with all parties at every important step of the branding development process. Each option proposed by the global marketing team was explained, discussed, and altered if needed, based on the comments received. The process requires persistence, openness, and the ability to listen to ideas from others. But it has the benefit of rallying the whole company behind the branding strategy. At the same time, irrelevant requests, suggestions, or foot dragging must be dealt with respectfully but firmly.

In the case of Gilead's new HIV product, Viread, a country affiliate had developed a visual aid that diverged from the global branding guidelines. During a review meeting, the affiliate presented no clear rationale to support the new concept and agreed to correct the visual aid. Ultimately, that country's launch was one of the most successful worldwide. Sometimes, late in the process, local companies express differences of opinion and will try to develop local programs that significantly deviate from global strategies. This is understandable if they have not been involved in the development of the global programs or if those programs are inadequate. But it is otherwise counterproductive and expensive for the company. In such situations, global marketers must be able to reason, explain, and persuade affiliates to stick to the plan. They must also be ready to recognize mistakes and adjust rapidly when needed.

Execution. At most major pharma companies, the execution of marketing strategies is left to local managers, without commitment or control from company management. This is an incredible waste of time and resources for the company and results in inconsistent programs and a loss of brand identity.

In today's markets, where harmonization tends to rule, pharmaceutical companies should not readily accept major strategy and program differences between countries. Local managers must be held accountable for implementing global plans and should be required to explain why a particular strategy or program cannot be done locally, if they intend to do something different. Regular prelaunch review meetings with affiliates and brand team meetings, in which local managers present and justify their plans and key promotional programs, are essential to review and evaluate local programs on an ongoing basis.

Room for Improvement

Although some companies have created global marketing or branding departments, the value of such units may not be fully understood by senior managers who haven't been exposed to them. Advertising executives say that very few companies have effective global marketing departments. Local markets still have too much flexibility and can often choose their own campaigns without challenge. On the other hand, global marketing departments often forget that their primary responsibility is to develop a vision for the brand that can be efficiently and consistently implemented everywhere. "Think globally, act locally" is the key to successful global marketing.

Market differences between countries still remain and should not be underestimated. There is, however, no justification for the absence of a global marketing department. It seems inevitable that in the future many of the differences in competitive environments will be minimized.

As regulatory harmonization continues and product labels become more uniform between countries, the implementation of global marketing strategies will get easier. Global marketing departments are uniquely positioned to develop and carry out these strategies. Companies that establish these departments will see immediate benefits, including cost savings, greater efficiency, and branding consistency. But to be successful, global marketers must be accepted and valued by all company functions. And to do that, they need a clear definition and understanding of their mandate, their role, and their limitations.