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European Biopharmaceutical Review

Global Challenges

Recent reports suggest that the biopharmaceutical industry has 5,408 new medicines in clinical development globally (1). This is welcome news at a time when the industry faces a new and growing set of challenges in terms of communication, cost bases, patient engagement and patent expiry.

This article focuses on three areas in which multilingual communications and cross-cultural knowledge are indispensable for the biopharmaceutical industry to achieve continued international growth: patent protection, social media and trial outsourcing.

Protecting Your Intellectual Property

Obtaining a patent for multiple countries can be arduous, and the international legal requirements are subject to change. In the biopharma industry, even the definition of what is patentable is by no means fixed, and a number of applications are subject to litigation (2).

The European Patent Office (EPO) received 258,000 patent applications in 2012, representing an increase of almost six per cent on the previous year (3). As always, biopharmaceutical patents make up a significant proportion of that increase.

In line with the existing system, those seeking European-wide patent protection must file an application with the EPO. This application must be translated into one of the official languages of the EPO: English, French or German.

Once the patent is granted by the EPO, it must then be validated in every country where patent protection is required. The process of validation entails further translation of at least portions of the patent application into the local language of each country. There may also be additional fees at a national level.

Patent applications are an increasingly international affair. The top five positions for applications to the EPO in 2012 were held by the US (24.7 per cent), Japan (19.9 per cent), Germany (13.4 per cent), China (7.3 per cent) and Korea (5.5 per cent). So it is not difficult to imagine the sheer volume of translation that is taking place to get all of these patents granted and validated in the desired areas of protection. The rise of applications from Asia continues to play an important role, with over 50 per cent coming from Japan, China and Korea combined.

It is important to know what is required to protect your invention, and this can vary greatly. To take the Balkans as an example, it is helpful to know that Serbian and Montenegro are the same for the purposes of a patent; and that a Serbian translation can be used in Bosnia, but not vice versa, as in Serbia the whole patent is translated, whereas in Bosnia only the claims are. Croatian translations can also be used for protection in Bosnia.

Unitary Patent System

However, the patent process in Europe is changing: a new unitary patent is being developed for introduction as early as 2014, under which anyone who holds patent protection across the European Union (EU) may file an application in one language across all of the 25 participating member states. This means that no country-by-country translation fees would apply. According to the European Commission, the unitary patent system will bring the cost of a unitary patent to under €5,000 once it is in full force. The unitary patent will be valid in 25 EU states; currently Spain and Italy have declined to participate in the system.

It is important to note that the unitary patent will not replace the current system of European national patents, but will operate alongside it. However, it is unlikely that anyone is going to choose the greater logistical difficulty and expense of the old system, if the one language equivalent provides the same protection at a much lower cost.

Going outside of Europe, some interesting trends are developing in Chinese patent applications which suggest that in much of Asia intellectual property is still a local concern that is driven in large part by state subsidies; fewer than five per cent of Chinese innovators sought international patents between 2005 and 2009 (4).

Going Social and Local

Much has been made in recent years of the opportunities open to the biopharmaceutical industry as a result of the explosion of social media. It almost goes without saying that companies that do not have a social media presence are missing out on a big slice of the marketing pie.

Engagement is one of the key concepts of the pharmaceutical industry; it is by engaging with potential and existing patients that companies increase brand awareness and engender brand loyalty.

Social media communication must be targeted, but aim at active engagement, not at the presentation of passively digested information. Inviting comments, encouraging sharing and redistribution of content, generating conversations and debates – these are all means of engagement, ways in which to involve the users of social media in your company’s brand community.

When taking social media international, it is crucial to engage people by communicating with them in their own language and dialect. This also means ‘speaking their language’ more generally – what makes your target audience tick? What interests them? How can your company and what you do appeal to them and fi t into the bigger picture? One way to approach this is by segmenting your audience by age group, gender, even in larger demographics by region, to ensure that you are pushing the most effective and appropriate content for each segment.

Early adopters of social media like Roche are now seen as trailblazers in their area of the industry, and deservedly so, as a glance at their local social media efforts shows (5).

Crowdsourcing

There are other social media decisions to be made before going international. For example, do you intend to introduce an element of multilingual crowdsourcing? This is, incidentally, one approach taken by Twitter, by appealing to users to translate content and validate other users’ translations.

Many pharma marketers will understandably bridle at the thought of crowdsourcing translation of social media content: yes, it may be less expensive than paying a professional agency, but how can you control the content? You are allowing third parties to represent your brand; not the best means to brand integrity. Even if you are crowdsourcing from within your own pool of employees, some may be reluctant to do it for fear of saying something out of turn and putting the company – and their own positions – in jeopardy.

Strict control of social media content is unavoidable in a heavily regulated industry like pharma, as companies seek to ensure compliance with industry and local-specific rules and regulations about what can be stated, and how. It is a question of adopting a Roche-like approach, being clear from the outset about what your objectives are, and what you may and may not post.

Also from a practical point of view, how local should you go with social media? This depends on the platform. Twitter is more suited to multiple accounts due to the nature of the user interface (releasing the same tweet in various languages from a centrally controlled page could create a negative saturation effect). Facebook, on the other hand, allows targeting of users by distributing certain messages only to followers in a certain locale, so that all communications can be managed from a central page if the administrator knows how to use Facebook in a more advanced way.

Of course, all of these decisions require resources to be dedicated to them, so the availability of resources must be factored in before embarking on a social media campaign. What is clear is that engagement on local social media is essential if you are trying to target a market, whether you are recruiting patients, distributing patient information, or marketing a product.

Global Outsourcing

It is now well known that outsourcing has gone truly international, as biopharma companies, contract research organisations (CROs) and contract manufacturing organisations (CMOs) seek out less expensive arenas to conduct research and manufacture products. This is especially true of global clinical trials. A study in The Lancet estimated that there are 150,000 patients involved in around 2,000 clinical trials in India alone. However, there are some concerns within the industry; for example, recent reports suggest that some of the most cited reasons why biopharma CMOs have avoided emerging markets are cultural and linguistic differences (6).

It is not melodramatic to say that lives depend on the quality of communication in the patient and doctor materials used in global clinical studies. Clear communication to patients of concepts such as placebo and informed consent is indispensable from a legal and, more importantly, an ethical point of view. Cultural sensitivities must also be taken into consideration, allowing for the world’s various takes on medical norms and the family unit, for example. This is particularly important for patient reported outcomes, where scales and questionnaires need to undergo a thorough process of linguistic validation, as well as cognitive debriefing, before they can be submitted to the Food and Drug Administration. Market research at the feasibility stage and perhaps a little cross-cultural training are great tools to empower decision-makers.

Again, success depends on speaking the participant’s language. To stay with India, the national Census in 2001 revealed there are 30 languages which have in excess of a million native speakers, and 122 with more than 10,000 native speakers. In the wrong hands, this makes it a minefi eld for incorrect communications.

Translation Expertise

But perhaps as important as getting the language right for clinical trials is ensuring that the translators have the correct expertise and experience. This is understandably easier and less expensive to achieve in Hindi than it is in Garhwali, an Indian language which few have even heard of, but which boasts over 2.2 million speakers in the northern Indian state of Uttarakhand.

Whatever the language, the translators need to have technical expertise, but also understand where they fit into the clinical trial process, what happens before and after the distribution of the material they are translating, and – crucially – the reading and comprehension level that the material needs to be aimed at (normally between 10 and 12 years old for patientfacing material). For obvious reasons, it is important that the patients can easily understand the commitments they are making and the risks associated with the treatments they are consenting to undergo.

The best way to minimise the risk of problems in the translations for clinical trials is to do everything possible to ensure that the source patient materials are ready before commissioning multilingual versions. If possible, have the source text independently proofread for typos. It is much quicker to correct an error at the source level than to correct it in the source and in 30 other languages.

Involving and consulting a trusted vendor earlier in the process and making them aware in advance of any deadlines you are up against will enable the planning and execution of multilingual clinical documentation to be much smoother.

Clear Communication

All three of the areas discussed represent challenges to biopharma companies and their partners. The difficulties are by no means insurmountable, but require two commitments from those who are responsible for international communications.

First, there is a need for recognition of the importance of international outreach, whether it be to protect drugs, biologics or devices; to reach huge untapped patient and/or customer markets through social media engagement; or going global with clinical trials.

Biopharma companies and their partners must commit to the notion that a global programme needs to work just as well in Vietnam as it does in Vermont; the multilingual content needs as much time, care and attention as the English.

Having recognised the opportunities provided by globalisation and the continuing opening of markets, those who handle communications in the industry need to be shrewd and judicious in selecting their target markets and segmenting their target base in order to maximise return on investment.

What is clear is that the development of a clear strategy before applying for and validating a patent, a structured and integrated approach to social media, and a holistic plan to become culturally and linguistically aware when taking your clinical trial global are crucial. Only by making these commitments can you be sure that your international communications are effective and achieve their aim.

References

1. www.pharmatimes.com/article/13-0121/ global_biopharma_5_408_new_ medicines_now_in_r_d.aspx

2. www.pharmacompliancemonitor.com/ 2012-highlights-for-biopharma-patentcases/3942/

3. www.epo.org/news-issues/ news/2013/20130117.html

4. www.economist.com/news/ business/21569062-valuing-patents

5. www.roche.com/about_roche/at_a_ glance/socialmedia.htm

6. www.outsourcing-pharma.com/contractmanufacturing/ biopharma-cmo-market-srecent- downturn-could-be-short-lived


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Chris McCourt is an Account Executive in the Life Sciences division of TransPerfect, a leading provider of language services and global clinical development solutions. After graduating with a first class degree in Modern Languages from Oxford University in 2009, Chris worked in the localisation industry in production and account management roles before taking up his current position.
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