Pharmaceutical companies are increasingly looking beyond core international markets to drive future revenues. As traditional markets mature, multinationals have identified the developing nations as their most likely growth engine. Optimising the so-called ‘emerging markets’ has itself emerged as a key strategy across the industry.
Many of the sector’s biggest players are establishing operations in hitherto under-developed nations. Moreover, clinical trials are being conducted in many more countries across the world. This is driving a fundamental change in data source – and forcing pharma to reassess aspects of its traditional operating model. One such aspect is publication planning. How has the industry’s growing focus on emerging markets impacted this crucial activity? Does the simple combination of engaging with new customers in ‘new’ countries naturally dictate a new model for publication planning?
Emerging definitions
The term ‘emerging market’ is a broad church. The most advanced appear to be the BRIC nations (Brazil, Russia, India, China), but other countries are growing rapidly and presenting opportunities for pharma. IMS Health’s 2012 report into ‘pharmemerging’ markets identified Argentina, Venezuela, Mexico and Turkey among the 17 fastest-growing developing nations.
Beyond the obvious socio-economic factors that are propelling growth in these countries, one common denominator that appears to unite them all – and marks them out for pharma attention – is their attempts to increase patient access to healthcare. The movement towards systems of universal access is gathering pace and, as governments seek to reduce variations in care, pharma is waiting patiently in the wings.
The industry has extended its research activities into emerging markets significantly, particularly in the Asia Pacific (AP) region. This increase in the number of clinical studies has facilitated the emergence of huge amounts of research data – and a parallel rise in the need for that data to be published.
Consequently, the need for emerging markets to be educated around publication planning has intensifed. But with each country having its own cultural idiosyncrasies, does this mean that publication planning methodology needs to change? The answer, in terms of good practice and governance, is an emphatic no. The definitive principles of publication planning remain the same. But the utility of publications in driving clinical practice is dependent on cultural understanding and nuance.
Publication planning is the appropriate, credible and unbiased dissemination of all data emerging from the research process, in an organised fashion to meet the informational needs of healthcare audiences. This simple definition has enabled publication planning to broaden in line with market evolution.
The number of publication outlets has, over time, expanded beyond peer-reviewed journals and into satellite symposia, international meetings and online media. Likewise, whereas traditional publication planning commonly focused on scientific exchange with HCPs, the rising importance of payers has meant that health economic data has become a vitally important aspect of the publication plan. Moreover, data is now as likely to be sourced from a real world trial as it is an RCT.
The overall purpose of a publication plan is to provide an unbiased and citable record of the science, and to support turning this data into clinical action. It is a crucial scientific exchange that aims to inform clinical behaviour and optimise the management of disease. But, while the delivery of publication planning has evolved to suit market needs, its core principles remain the same – whatever the marketplace.
These principles generally revolve around Good Publication Practice. “Ethical standards around balance, transparency and authorship are immutable and must be applied globally,” says Charlie Buckwell, chief executive, McCann Complete Medical.
“In the age of social media, the impact of bad publication practice is huge. A minor mistake in an emerging market can reverberate around the globe. Whether you are translating globally-derived data to local markets to help local decision-making, or using locally-derived data in major publications for a global impact – and the two are quite distinct – the core ethical principles of publication planning must be upheld.”
On this basis, is the idea that emerging markets may be facilitating a change in publication planning methodology a red herring? Maybe.
“Publication practice is publication practice, no matter where you do it,” says Julia Ralston, CEO, MedErgy Health Group and a former President of the International Society of Medical Publication Professionals (ISMPP). “Whether you are responsible for publication planning or supporting a publication process, you should be applying the same principles. Best practice needs to be universal.”
Ethical standards around balance, transparency and authorship … must be applied globally
The trick, says Ralston, is to strike the right balance between compliance and culture. “It’s clearly important to look at your local environment and establish what’s different. Clinical practice, or the way you context your data relative to local practice, may need to vary.
“Cultural nuances will always come into play. But, whether you’re in the US, China, Australia or India, there is no need to preach a different approach. The governance is well established and everybody should be adopting it. Whether you’re talking globally or locally, in a mature market or an emerging one, it really shouldn’t make any difference.”
Think local
The well-worn notion of ‘think global, act local’ applies throughout. Dr Martin Godfrey, managing director, Wells Healthcare, says: “A publication plan is like an onion. At its core, the industry is looking for publications with the highest impact factor – and these will often tend to be the major international publications from Europe or the US. But if you’re looking at markets in the Middle East or Asia, you need to peel back the next ring of the onion and look for local publications that suit your needs.
“This requires a certain level of tailoring and a good understanding of the local environment. Not only do you need a comprehensive view of the medical meetings and publications that exist in the local market, but you must also have a detailed knowledge of when the clinical trials are going to be finalised and the data available.
“This means working hand in glove with a partner so that a manuscript can be developed in harmony with the trial results, and coordinated so that it is published in areas where there is the highest impact. Ideally, it’s best to have a publications committee, enabling data owners to have contact with local operations to support the research process. Fundamentally, the publications process is the same everywhere – but it needs a level of tailoring to ensure it’s in tune with local languages and cultures.”
Dr Karl Torbey, medical director, AdelphiEden Health Communications, agrees: “An appreciation for the culture-specific and region-specific drivers is essential before proceeding with a typical Western publication plan. For example, in the Far East, there is deference to authority: junior personnel may defer or refuse deserved first-authorship. Equally, some diseases are perceived very differently depending on where you are. One size definitely does not fit all; what works well in Mesopotamia may flop in North Africa. Religion and other variables can influence things like KOL mapping exercises. The key is to adapt. The reed that bends survives the storm.”
Nowhere is the ‘East-meets-West’ culture laid out more starkly than in Asia Pacific. Professor Karen Woolley, CEO, ProScribe Medical Communications and inaugural chair of the Asia Pacific Advisory Committee, ISMPP, says: “There are notable exceptions to the rule, but publication planning and publication steering committees are still relatively new concepts in the heterogeneous Asia Pacific region. The need for publication planning, however, is increasing rapidly as more global teams in the US and EU recognise the global shift toward the AP region and the impact this is having on healthcare research and publications.
“The Chinese Academy of Sciences, for example, already publishes three times as many papers as the NIH (National Institutes of Health). The reach of international legislation and compliance concerns, as well as local industry codes, mean that regional publication planning and delivery have to be approached with an absolute commitment to ethical practices. This commitment translates into nothing, however, unless coupled closely with cultural sensitivity.
“A failure to appreciate the cultural elements of countries can undermine the development and delivery of publication plans. In the AP, key aspects such as how you run a PSC meeting, approach documentation, enlist affiliate support and discuss journal choices, can all differ from approaches used routinely in the US and EU.
“Publication planning is a new frontier in the AP. As the region becomes the new superpower in medical literature, it is critical – for ethical, scientific and clinical reasons – that we get it right.”
Emerging models
The AP market is characteristic of all developing regions. “Emerging markets are all incredibly heterogeneous,” says Buckwell. “Cultures and attitudes to disease and treatment vary enormously. Likewise, healthcare systems and infrastructure differ greatly. Faced with the globalisation of data, the industry’s challenge is to achieve scientific exchange in a heterogenic environment – and to make it manageable. It’s simply not possible to have 170 different strategies for all the different countries – but it is possible to develop models for different types of environments, to provide a consistent baseline that can act as a platform for tailored plans. And these should all be underpinned by global standards.”
The heterogenic nature of the global marketplace will continue to present challenges to the industry as it seeks to increase trust in its dissemination of scientific information.
An appreciation of the culture-specific and region-specific drivers is essential before proceeding …
Publication planning and the robust implementation of global standards will continue to have a major role to play in enhancing pharma’s worldwide reputation – in both mature and emerging markets. But success will be a collective responsibility.
“We are working towards a goal where we have universal understanding of best practice across the entire process, and that the same support mechanisms and education are in place all over the world,” says Ralston.
“But progress is still variable, particularly in some of the less developed countries. Organisations like ISMPP and other professional organisations are working to ensure there’s an effective understanding of publication practice every day and everywhere.”