‘Think global, act local’ is a familiar mantra in an ever more eclectic pharmaceutical market. Our downloadable e-book explores the many risks associated with launching medicines across national borders. This blog focuses on the critical need to optimise risk management by aligning global with local strategies.
The more emerging markets and digital networks expand the horizons of the pharmaceutical industry, the more vulnerable your product becomes to risks in the local environment.
These may include political instability, media hostility, labyrinthine supply chains, lax or heavy-handed regulation, ethical grey areas, currency fluctuations, economic upheavals, and impenetrable, sluggish or uncompetitive pricing and reimbursement procedures.
In at least some of these areas, only a highly localised approach will do – or rather a keen awareness that global strategies favouring harmonisation, standardisation and economies of scale must allow for local insight and flexibility if launch risks are to be anticipated and managed effectively.
Trend to harmonisation
Globalisation in pharmaceuticals has benefited from an iterative trend towards harmonisation of legislative, regulatory and quality standards, driven by institutions and initiatives such as the European Commission and the International Conference on Harmonisation (ICH).
These processes have ironed out many of the disparities and duplications that impede market access for medicines. Yet significant variations persist, some of them inevitable and some tied to national industrial, political or economic policies, cultural or linguistic distinctions, historical neglect or the gulf between rich and poor populations.
In the nominally harmonised European Union, economically and politically sensitive issues such as pricing and reimbursement are left largely to national discretion. That is likely to continue, given that healthcare funding is inseparable from local demographics, disease profiles and budgetary priorities.
In some emerging markets, on the other hand, slow progress towards global standards in areas such as intellectual property may reflect protectionist concerns around cultivating local industry or tempering demand for expensive medicines.
The picture is further muddied by economic volatility that can abruptly reshape the market-access landscape in countries as various as Greece, Spain, Lithuania or China, as well as complex local infrastructures for the purchase, supply and distribution of medicines.
These discrepancies multiply the risks of:
• unforeseen regulatory delays;
• additional time and expense generating market-specific data or labelling;
• disparities in pricing and reimbursement;
• product diversion;
• reputational damage;
• failure to launch.
Crucial launch factors such as pricing, reimbursement and health-technology assessment are also subject increasingly to referencing from one market to the next. Launch sequencing or optimal pricing may be undermined by referencing to low price points in economically constrained markets or by exploitation of price differentials to drive parallel imports.
In this context, global to local alignment, with enough transparency, visibility and sensitivity to realise when and how global strategies must bend to local considerations, should always remain central to the product launch.
Here are three examples of where things can go wrong, the potential impact on product roll-out, and how problems can be remedied by an effective, real-time launch-awareness tool:
Launch Risk 1: The global launch strategy, and its local adaptations, are not communicated fully and seamlessly across brand teams, departments and country management.
Any breakdown in communication internally can lead to misunderstanding, poor judgment and misalignment when a launch strategy is rolled out globally.
The result may be deferred market access; dilution of product branding; sub-optimal pricing or reimbursement; negative publicity susceptible to political opportunism; or, with extended delays, changes in market conditions that may require substantial amendments to the launch plan.
A well-equipped digital launch tool enables real-time communication between launch teams, as well as individual team members, across national, departmental and functional boundaries.
Comprehensive visualisation of launch concepts, strategies and processes, as they are activated from market to market, ensures not only that key personnel are kept in the loop but that any emerging issues are quickly identified, understood and addressed at global and local level.
Launch Risk 2: Neither the product branding nor the marketing strategy is consistent across markets.
In a crowded market, where companies must work harder than ever to convince regulatory authorities, healthcare professionals and budget holders that their product offers genuine value, strong, consistent branding is imperative to differentiate your product from its competitors.
It must be backed up by a fully aligned marketing and promotional strategy, one that incorporates enough flexibility to accommodate local variations in the market-access environment.
With a professional launch-readiness tool, consistent visualisation of launch processes and strategies, together with the ability to drill down from brands through to launch markets and functional issues, ensure that key strategies and activities are fully aligned across the organisation.
This mitigates the risk of branding or marketing straying off message. At the same time, it flags up any national developments that call for adjustment of branding, messaging or promotional tactics to accommodate local needs.
Launch Risk 3: Launch teams both globally and in individual markets are not keeping pace with planned tasks and milestones.
Timing is crucial to any product launch. Even a short delay in accessing the market can put your drug at a significant disadvantage.
Launching a medicine involves a number of risk-sensitive processes, from setting up manufacturing and packaging to securing timely approvals; working through pricing and reimbursement systems; cultivating key opinion leaders; developing, synchronizing and clearing promotional and advertising campaigns; and priming supply chains.
While market-to-market discrepancies are likely to frustrate even the best-laid plans, keeping all of these elements on course and on schedule as much as possible will lower the risk of missed milestones throwing the whole product roll-out into jeopardy.
An effective digital launch tool can track compliance with launch tasks and milestones, quickly addressing any local divergence and providing a real-time platform for dialogue and resolution. Documents are updated in situ and made available instantly to colleagues, reducing potential for human error and communication bottlenecks.
TRiBECA® Knowledge is a market leader in smart digital launch tools that help pharmaceutical companies to optimise launch readiness. For the full range of risks associated with global product launches, download our new e-book '10 Launch Risks that can be controlled and managed'.