Latin America Language Diversity & Tax Hurdles Basics


Ref. Pharma, July - August 2009, Vol 5 Num 4.

Tax or No Tax

Risks associated with patent protection and counterfeiting are sometimes offset by tax incentives in more developed countries, but that is not the case in Latin America. As a case in point, Brazil has the highest tax on medicine at an astonishing rate of 30%, making it one of the highest in the world. No wonder companies have found some solace in Puerto Rico where the government can eliminate the tax entirely. This incentive goes to companies that introduce innovative technologies to the region. Even without this sweetheart deal, Puerto Rico tax rates peak at 7%, making it one of the most desirable place to do clinical trials and market pharmaceuticals.

Added Costs:

Owing to the off-shore nature of its location, Latin America can have added trial-related costs, such as personnel costs (for monitoring, source document verification, site visits) and training expenses (investigator and co-ordinator meetings, ongoing support pre- and post-enrollment). Examples of other trial-related documents and materials that often require translation include the following:

  • Investigator brochures
  • Study protocols
  • Approval letters from regulatory authorities, review boards and ethical committees
  • Questionnaires, instructions for investigators and nurses, etc.
  • Packaging (inner and outer) and labeling
  • Instructions for automatic randomization
  • Patient diaries
  • Electronic Data Capture (EDC)
  • IVRS (voice recording)
  • Adverse events reporting
  • Notice of study discontinuation or close out.

Unity in Diversity

The main languages spoken in Latin America — Brazilian Portuguese, the Latin American varieties of Spanish as well as French — are among the most widely spoken in the world, and pose no new challenges during translation. Eleven of the twelve independent countries in South America speak Spanish, and the overall linguistic and cultural unity of the continent is a unique advantage for conducting clinical trials, compared with other global trial locations such as Central and Eastern Europe or Asia (other than China), which are made of a number of countries using different languages. At the same time, there is no such thing as a single standard and unified Latin American Spanish in the region. There are regional differences between the Spanish spoken in individual countries. The term “LA Spanish” and its choice as a target language is often really an effort by companies to try to reduce translation costs, and to try to find a common ground that would be acceptable in every country, even if not using the country specific vocabulary. This means that a decision needs to be made each time on what kind of Spanish will be most appropriate for the given market or type of material.

Brazilian Portuguese

Brazilian Portuguese ó as a language with some spelling, lexicon and grammatical differences from the European Portuguese used mostly in Portugal ó has undergone an interesting development recently.

New spelling rules, as agreed by all 8 Portuguese-speaking countries in the form of the Orthographic Agreement of 1990, were officially adopted in Brazil on 1 January 2009, the first country to adopt the new rules. The unified spelling may only affect a relatively small number of words (some 0.5% of those used in Brazil), but this should remove 98% of the spelling discrepancies between the two variants of Portuguese (that used in Brazil and that used elsewhere). Portugal may adopt this standard before January 2010, although it is not required to do so before 2014. Even though the lexical differences will remain, overall, this unification is set to decrease the costs of Portuguese translations and will enable better reuse of translated content between these two markets.

Linguistic and Cultural Considerations

In May 2008, the “First Latin American Workshop on Ethics and Clinical Trials” was held in Buenos Aires, Argentina. The workshop was organized by the non-profit organization, Salud y Fármacos, with support from WEMOS (a Dutch foundation), the Health Science Center of the University of Texas and the Pan American Health Organization-Argentine. Salud y Fármacos and WEMOS have expressed concerns with the ethics regarding how clinical trials are conducted in Latin America. “The Buenos Aires Declaration on Ethics and Clinical Trials” was unanimously signed by participants in the workshop. It specifically addresses the need for cultural considerations and competent translation in the following sections from the declaration:

4. In Latin America, protocols originating from outside the region must be translated by competent expert translators for presentation to local authorities (the regulatory agencies, ethics committees, etc.) into the language of the country where the clinical trial takes place (Spanish, Portuguese or French). 5. The informed consent should fulfill the following requirements: a: Informed consent forms originating from outside the region must be translated by competent expert translators. b: Persons, totally independent from the clinical trial, must verify that all social and ethnic strata that participate in the trial understand clearly the content of the informed consent form. c: When indigenous populations participate in the trial, the informed consent form should be presented to them in their native language.”

Translation and Review In-Country

The keys to quality translation are using translators that are native speakers of the selected language, working in-country, careful consideration of the type of material being translated and the target audience.

This is especially important for clinical trials. Finding native-speaker, in-country translators with a proper command of the subject matter is always a challenge, and can be especially tricky when little-spoken indigenous languages are required. It cannot be assumed that an unlimited and readily available pool of ready-and-waiting qualified linguistic resources (especially for “exotic” languages) is in place.

There are often linguist technical issues (font support), terminology issues (Does the term exist in the language in question?) and infrastructure issues (simple telephone or Internet connection, access to basic translator tools) to be addressed. And lingering political feelings about current and historical linguistic concerns should not be overlooked. Find a professional translation partner with experience in the region to manage these complex issues! In-country reviews (ICRs) have also become one of the key elements of an efficient translation process. These serve primarily to ensure the technical accuracy and factual correctness of the translated content, and are done by medical professionals who have the practical experience in the subject area in the given country. This means they can assess, with authority, the accuracy and usability of the text in the local context, for the specified use, and how it complies with local practices and context.

The cost of translating is a very small fraction of the total costs of clinical trials or, indeed, the overall drug development process. But the costs of wrong translations are high and the risks very real. When translating content directly linked to regulatory approval or launching the drug — such as Patient Information Leaflets (PIL), packaging or Summary of Product Characteristics (SPC) — inadequate translation can push back a product launch or lead to product recalls. And, in some cases, can even lead to product liability lawsuits.

In clinical trials, the situation is similar. Using professional and qualified translation resources is critical and will accelerate clinical trials overseas ... as well as minimize any risks associated with inaccurate translations or blunt mistranslations. In summary, there are only a few official languages in this vast region, which can be helpful for clinical trials. At the same time, a considered approach is required to ensure an appropriate process for translating results in an accurate and appropriate way for every stage.

Summary

Despite overall regulatory drug approval timelines that may take longer than the United States or Europe, the overall enrollment time for trials conducted in Latin America can be shorter; there are fewer trials competing for the same patients, there are more patients per site and patients are easier to enroll than in the United States and Europe. Personnel costs, training expenses, establishing good relationships with investigators and regulatory authorities, plus language considerations are mission-critical elements that should be given serious thought prior to launching a clinical trial campaign in Latin America. Lastly, it is important to note that any company that wants to sponsor a clinical trial must appoint a local partner with expertise in the regulatory, medical, linguistic and cultural issues. The implications of not doing so can delay protocol approval, leading to lengthy completion times. At a potential loss of $1–3 million per day when a product does not make it to market, can anyone afford to take this risk?