The Translation of Medical Patents: An Introduction

Now, more than ever, we live in a globally connected world. Thanks to technology, progress and collaboration opportunities feel limitless. Language barriers don’t even exist anymore, with the services of professional translations available. Translation services are utilized in every area of the medical field. From medical devices to clinical trials. The translation of medical patents is yet  another area of the medical field that translators touch.

What are medical patents?

Traditionally, a patent is a legal instrument that gives the patent holder exclusive rights for making, selling, or offering to sell the subject matter that the patent “claims”. More specifically, medical patents may relate to pharmaceuticals. This can include the methods of making and using them. As well as medical treatment regimens, surgical procedures, medical devices, and health care information technology.

What is the purpose of medical patents?

The primary goal of a medical patent, or any patent, is to provide a unique marketing advantage to the inventor. Another goal is to limit the usability of any aspect of the subject matter of the patent for a set amount of time. This assists the patentee in limiting their competition. The patent can stop competitors from making, using, or selling the item or process outlined in the patent. These protections help the filer of the patent maintain the value of their invention.

You may be wondering who utilizes medical patents. Biotech companies, physicians, and universities are some of the most common to do so. Medical patents allow them to protect their inventions from their competition temporarily. The patentee can take advantage of this time period to generate revenue. Which will ideally help make up for any incurred research and development costs.

There is another great benefit to medical patents. One consumers can appreciate as much as creators. After receiving a New Drug Application (NDA) the Food and Drug Administration tests any medical product applicants for safety and effectiveness. This is a rigorous approval process that requires clinical trials and compliance with an extensive approval process. This can be an expensive step of the process, but is a necessary one. 

The translation of medical patents

You can file an international patent application in many languages, as long as the receiving office accepts that language. If you choose to file your application in a language that the International Searching Authority (ISA) does not accept, you must provide the ISA with a translation of the application. The ISA is one of the world’s major patent offices and it identifies published patent documents and technical literature that can influence if your invention is patentable. If your chosen language is not available for consideration, you always have the option of submitting your patent in Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian, and Spanish. These languages are official “publication languages”. And all receiving offices must accept these languages. This is the step in the process in which you may require the translation of medical patents.

The cost of medical patents

The cost of filing a patent may be one of the biggest challenges you’ll face. And the translation of medical patents will incur an additional cost. If you’re filing your patent in multiple countries, this cost can mount as each country will have its own set of fees. Not to mention the inventor may have to hire translation services to translate the patent into different languages for different countries they file in. Between filing fees, translation costs, and paying a patent lawyer, filing can cost anywhere from $2,000 to more than $20,000. These costs feel steep, but they protect both the creator of the invention and the consumers who will be using it.

The security you receive from medical patents, and the translation of medical patents, is undeniable. By filing your patent in multiple countries, you protect your invention in those regions. Because the wording of a patent certificate is very complex, it is important to work with a highly skilled translator and a subject matter expert. You want to ensure the specific terminology and details of the patent are understood properly. If the quality of translation is low, you risk dire legal and financial consequences. Errors in translation can result in the ineligibility of the patent in some markets. Investing in quality translation services will help protect your invention and your finances. 

Pharmaceutical Packaging Translation

Pharmaceutical Packaging Translation: A Growing Global Need

Language touches every area of our lives. Words can gift hope and faith. Or they can start wars. There is no denying that language can mean life or death. Especially when it comes to the medical industry. Mistranslation of medical terminology, treatments, or a patient’s history is extremely dangerous. The pharmaceutical packaging market in particular has rapidly growing translation needs. By 2025, it’s estimated that the pharmaceutical packaging market will be worth $128 billion. For comparison’s sake, as of 2015, the market’s worth was almost $69 billion.

Where is Growth Coming From?

Why such a large increase in growth? To start, there is an increased global demand for medication in emerging economies. Combine that fact with an aging population, increase in chronic diseases, antimicrobial resistance, and strict medical regulations. The Latin America market alone is anticipated to experience a Compounded Annual Growth Rate (CAGR) of 6.51% by 2022.

Where Translation Comes Into Play

Pharmaceutical packaging translation may not be an immediately apparent need. But when broken down, the amount of translation required is substantial. Not only do pharmaceutical labels need translation, but so do those hefty leaflets that come in the packing. All packages must include information on a pharmaceuticals’ name, strength, and form. Each will also contain a statement of active substances per dosage. As well as the method and route of administration. And of course, a warning to keep the product out of the reach of children.

All applicable warnings must be included, alongside the:

  • expiration date
  • special storage requirements
  • batch number
  • authorization number
  • disposal guidance
  • contact information for the marketing authorization holder
  • product’s name in braille

All of the above information must be written in the official languages of the country where the product is sold. Similar to medical devices, pharmaceutical products are regulated in most countries. Each having their own set of specific rules.

Canada is a prime example of what to expect when distributing pharmaceuticals in a country that has more than one national language. Because they have two official languages, English and French, pharmaceutical packaging translation is required to ensure both languages are present on required materials. Even if the drug is available for sale without a prescription, such as over the counter allergy medication. The EU requires Member States to make official languages clearly legible on packaging leaflets. In the EU, companies must comply with any guidelines enforced by the European Medicines Agency (EMA) and its Committee for Human Medicinal Products (CHMP), as well as abiding by any local regulations.

Pharmaceutical Packaging Translation Solutions

Pharmaceutical packaging translation requires a professional native speaking translator with medical translation experience and knowledge. Word for word translations aren’t sufficient for medical translations. They require a complete comprehension of the subject matter. As well as the ability to communicate the true meaning of the text. Which is why it’s important to utilize specialist native translators who have the cultural and linguistic experience required to properly translate pharmaceutical packaging. 

These types of translators are more in demand than ever due to the large amount of pharmaceuticals shipped across countries and continents. Not only does proper translation enhance a patient’s safety, but it helps maintain compliance with any country-specific regulatory requirements.

In order to accommodate multiple languages on packages, you can consider utilizing modern labeling techniques that allow more space for multiple translations of vital information. There are tools available that allow you to print multiple languages on one label. Because the label wraps around the prescription bottle multiple times, it can replace a standard adhesive label without negatively affecting legibility, packaging size, or appearance.

medical-records-translation

What is the Danger of an Incorrect Translation of Medical Records?

Caring for patients can come in many forms. And in many languages. For doctors to provide the best care possible to their patients, it is vital they have access to properly translated medical records. A patient’s medical records contain potentially lifesaving information about their medical histories. Let’s dig deeper into why the proper translation of medical records matters so much.

What Information Does a Medical Record Contain?

Not all medical records will contain the following information. In fact, some people have none to very little medical records at all. But generally, the information below may be found during the translation of medical records.

  1. Personal identification information: Such as their social security number or their government-issued identification number.
  2. Medical history: Their history may include past diagnoses, medical care records, allergies, and treatments they have received amongst other information.
  3. Family medical history: A patient’s family medical history can help draw attention to genetic health concerns.
  4. Medication history: Doctors need to know about any prescription, herbal, over the counter, and even home remedies that a patient may be taking or have taken in the past. 
  5. Treatment history: Knowing if a patient has received a treatment, and whether it was successful or not, is valuable information for a medical provider.
  6. Medical directives: While not all patients will have a medical directive on record, it is important to understand their directive clearly if they do. Generally this document is kept on file and details the medical wishes of a patient if they are unable to speak for themselves.

Why are Medical Records Important?

All of the information about a patient’s medical history that their record may contain are key pieces of their treatment puzzles. If any of the information in a medical record is mistranslated, patients are no longer receiving the care they deserve.

These records allow physicians and medical staff to better understand a patient’s medical history and their current diagnosis. Creating a topnotch treatment plan can also be aided by the complete translation of medical records. 

If a patient is not able to communicate clearly with their doctor, which can happen regardless of a language barrier, the results of treatment can be disastrous. An unknown allergy to a medication can cause fatality. And not knowing what treatments a patient’s body doesn’t respond to can be dangerous and waste precious time.

What Mistranslation Can Cause

One example of the dangers of mistranslating a medical record is an unfortunate story about an English woman living in Spain. Teresa Tarry was supposed to have surgery for a benign lump in 2007. Instead, she left surgery with 55% incapacity and believed she had a cancerous tumor. Weeks later she discovered that the lump was not actually cancerous. The doctors at A Coruna’s Abente y Lago hospital misinterpreted her medical records. A translation mistake led the doctors to believe Tarry had a family history of breast cancer. Even though there was no such history. Without a family history of breast cancer, there was no need for such aggressive preventative treatment. A small misunderstanding damaged the quality of her health and life forever.

Translation of Medical Research: an International Need

Progress is a collaborative effort. By tapping into an international network, researchers can learn, discover, and create at a faster rate than ever before. In order to collaborate across the globe, the translation of medical research becomes an unavoidable need.

Medical research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” under the  Health Insurance Portability and Accountability Act (HIPAA). This broad definition can include biomedical research, health services research, and epidemiological studies. It can also include studies of the behavioral, social, and economic factors that affect health.

Medical research provides a high value to society. This research can provide vital information regarding:

  • The outcomes of treatment or public health interventions
  • Functional abilities
  • Health care costs and use
  • Disease trends
  • Risk factors
  • Patterns of care

Clinical trials are one of the more familiar forms of health research. A clinical trial involves patients volunteering to participate in studies so that researchers can test the safety and effectiveness of new medical interventions.

The Need for Translation of Medical Research

Because an increasingly large portion of health research is information based, there is a great need for the translation of medical research. This research is heavily information based. It can include the analysis of data and biological samples required for the purposes of diagnostic, treatment, or billing.

As the field of science is changing rapidly and increasing in complexity, it is impossible for any single researcher or institution to have the required expertise to develop and validate the safety of a given medical innovation. The sharing of information between medical institutions is essential to the success and safety of medical advancements.

The Language Barrier

Until recently, English has been considered the lingua franca (aka a language that is adopted as a common language between speakers whose native languages are different) in medicine. As of 2012, roughly 80% of all scientific journals indexed in Scopus (a large abstract and citation database) were published in English. But as more and more scientific cultures are now developing in many countries around the world, there is an increasing amount of journals being published in the national languages.

Non-English language based medical communities are growing in strength. Germany is one such country expressing a strong interest in working with materials written in their native language. When polled, seven out of 10 German physicians reported that it was important or very important that the medical articles they read are in German.

In India, authorities are pushing to provide all research papers bilingually so there is less of a language barrier. K Vijay Raghavan, a principal scientific advisor to the Government of India, told the Education Times that, “The power to grasp complex scientific concepts and analyse problems comes best to researchers when they are pursuing science in their own language.” He noted that researchers also need to have a proficient understanding of English as it is still the international language of science. “Thus, our goal is to have all kinds of literature and reference material — from school to research — available bilingually so that researchers who work in native languages can benefit from them,” Raghavan said.

Translation of Clinical Trials Protocols Course: Lessons We’ve Learned 

Recently, two of our hard-working teammates, Silvina and Celeste, took on an intensive training course regarding the translation of clinical trials protocols. The course was taught by Pablo Mugüerza, a very prestigious medical translator, and the course load consisted of about 40 hours worth of material. The material covered topics such as medical terminology and theory. There were also opportunities to practice analyzing different translations. We sat down with our two stellar translators to get their takeaways on the training. They reflected on what they learned and how their new knowledge base will help them moving forward.

What is a Clinical Trial Protocol?

The focus of their training was understanding and enacting correct translation of clinical trials protocols. Celeste explains a clinical trial protocol as an “informative document for the investigators that will conduct the trial. It explains everything that is going to happen, as well as what they should and shouldn’t do.” This document also informs the investigator how the patient will be treated, and what both the benefits and risks are of that medical treatment. She continued to breakdown what a protocol entails, “It explains the design of the trial, how long it will take, where it will be conducted, what medications are being studied, and what is expected of the trial. It also states the purpose of the trial and what they are trying to discover.”

How Was the Training Structured?

For each of the four weeks of the course, the students covered a module that consisted of theory and 25 new terms related to clinical trials. They also tackled translation exercises. According to Silvina, at the end of each module, “There was an exercise, a translation test for us to do. We also had a recap activity to review the terms.” Their weekly assignments were just the beginning. Silvina noted that each week they took tests to confirm they understood and retained the knowledge they learned. There was also a final exam at the end of the training, which they both passed with flying colors. This was an “online test which consisted of fifteen questions about the terms we had learned. And the last week, we also had a final exam. So it was hard work,” Silvina said.

What Were the Objectives of the Course?

The first goal of the course was to gain a deeper view of what a protocol and a clinical trial is. Alongside learning 100 new pieces of terminology and how to properly approach the translation of clinical trials protocols.“My expectations were to learn more terminology, because there is so much information required to specialize in that field. You need to be able to really understand what you have to translate into Spanish,” said Celeste.

What Were the Takeaways?

Both Silvina and Celeste found that this training served as a reminder of the value of education. In a field as critical and challenging as medical translation, it’s key to stay on top of vocabulary, medical advances, and best practices. Silvina greatly appreciates Terra Translation’s commitment to education and training. “I think that training is essential nowadays. In many professions, not only in translation. Because everything is changing and advancing so fast. We must keep abreast of the latest research in this field,” Silvina said.

Celeste also believes adaptability is vital, “You have to be flexible and open minded. You need to know that the education is never going to end. The great thing about being a translator is that you are always learning, it never ends.”

medical-devices-translation

Why the Translation of Medical Devices is Crucial

Every patient deserves the best care possible. Having a language barrier does not warrant an exception. That’s why it is so vital the translation of medical devices documentation is performed by qualified translation professionals. The process of medical translation deserves the utmost care and professionalism at all times. There are many reasons the proper translation of medical devices is so crucial, the following reasons are a few of them.

Global Reach

With the global over-65 population expected to rise up to 1 billion by 2020, medical devices that improve the quality of life should show steady growth in demand. As will the need for proper medical translation services that ensure user manuals, marketing materials, and medical communications are accessible around the world.

According to OEC, the United States of America is the top exporter of medical devices and mainly exports to the European Union (EU). This means that medical device companies should consider working with qualified translators to make sure their products’ documentation is understandable for the end user. There are 24 official languages spoken in the EU and most countries in the EU require translations into a minimum of one of their official languages. Sometimes more languages are required. Belgium is a prime example. They require French, German, and Dutch translations.

Why Compliance Matters

Compliance is a key element in the localization of medical devices. Manufacturers need to follow the regulations of the countries where they want to market their devices. To market medical devices and their accessories in foreign markets, companies need to remain compliant with international and local regulations in each country.

So how do you balance language requirements if you are exporting medical devices to multiple countries? Generally, there is a strict regulatory approval process for medical devices. You need to review each country’s regulations as they can differ. However, the one overlapping requirement is to provide medical device documentation translation. Any content that goes hand in hand with a medical device must be submitted in the required languages. This content can include:

  • Packaging, labels, mailing materials
  • Usage instructions
  • User interface and software
  • Marketing materials
  • Technical information
  • Patient literature

This is where things get tricky. 22 out of 28 of the EU member states require companies label their medical devices in an official language. Even if the device is intended for only professional usage. That means you may have to translate a device’s supporting documents into all the languages commonly spoken in that region. If you’re looking to distribute your device in the EU, there are six EU member states that accept labeling medical devices in English. However, the device has to be for professional use only. Also, there are some regulatory authorities that might allow limitations to the translation of medical devices requirements. One could be that you only have to translate the device identification label, operating, and safety information. Exceptions like these are why it’s imperative you have a clear understanding of each country’s requirements.

Safety First

Why are the language rules regarding medical devices so stringent? When the lives and well being of patients are at stake, there is no room for error. Simply, being bilingual is not a sufficient skillset to safely handle the translation of medical devices. The patients, doctors, and general public, all deserve high-quality and accurate translations of the content associated with medical devices.

The Vital Importance of Translation of Clinical Trials

Clinical trials are an undeniably important step towards making medical progress. However, that progress can not come at the cost of trial participants. The participant’s ability to understand everything a medical trial involves is equally important. Proper translation of clinical trials is a necessary step in creating a safe clinical trial. Especially in low and middle-income countries where patients may only have access to medical care through clinical trials. There are the research needs of pharmaceutical companies and academia to consider as well. But at the end of the day, the needs of the participants are of the most vital importance.

The Stakes

There are regulations in place designed to protect patients who take part in a clinical trial. Protecting patients through a well-designed clinical trial is of the utmost importance. Legitimate translation of clinical trials can help avoid dangerous mistakes. The following steps of a trial require careful consideration because if there is failure to meet the ethical and specified guidelines, there is danger of incurring health risks and even causing patient fatality. Generally, Patient Reported Outcomes (PRO) have to be evaluated. The drug must also be determined as safe for human consumption.

The risks of mistranslation can include:

  • Improper translation may cause the patient to not understand or properly follow instructions.
  • The likelihood for appropriate follow up and treatment of any side effects of the trial decreases.
  • There may be disparities in prescription and administration of the study preparation.
  • Aside from the participant’s needs, faulty translation can cause damage to credibility and economic revenues.

The Reach

In recent years, more and more clinical trials are not held in their country of origin. The 20 largest pharmaceutical companies based in the United States conduct one-third of their clinical trials solely in foreign locations. It has also been found that the majority of study sites are outside of the United States. This shift to holding foreign trials means proper translation services are necessary to accurately implement and portray the outcome of a clinical trial. Foreign trial locations may have differing languages and cultures which can lead to confusion. A clinical translator can also help interpret PROs.

clinical-trials-translation

Source: clinicaltrials.gov

The Regulations

The obligation to translate documents related to clinical trials may vary from country to country. But in the United States there are set guidelines. Any documentation used for patients or investigators must be in the local language. When research by US companies is conducted in another country, the FDA still requires the company to comply with ethical standards.

While it may be tempting to conduct a trial without complete translation, this is the wrong course of action to take. Skipping proper translation of clinical trial efforts to reduce cost or time spent on a trial can be detrimental to a trial’s outcome. Translation services should be involved at many stages, including clinical research, regulator submission and review, production, and marketing. Improving your trial’s quality with translation services can in fact save more time and money than skipping this important step. Reducing the chances of facing a lawsuit or rejection by regulators are two more benefits of using a qualified translation service. But the safety of the final product and the trial itself should always be a company’s top priority.

medical translation

An Introduction to the Needs of Medical Translation

A passion for providing patients with the best possible care is something that guides many medical professionals throughout their careers. As our communities grow more diverse, the field of medical translation is growing too. This is a vast field and there is no way to fully summarize the goals and needs of the medical translation industry in brevity, but these are some of the basics that you need to know about this life-saving industry.

What Makes a Qualified Medical Translator

The standards required of a medical translator are more rigid than those expected of other translators. To translate a medical document accurately—which is of potentially grave importance— the translator is required to have a native (or close to native) level of language comprehension. They should also have analytical capabilities and deep cultural knowledge of the subject.

Ideally, a medical translator will have formal education in their native language as well as the one they are translating at a college level. Additional instruction in translation theory and practice is also a must. Because medical translation requires such a high level of accuracy, it’s important the translator is an expert on the subject matter, meaning they can fully understand the source text, write in the language, and can use industry specialized dictionaries. As a medical translator, it is necessary to research niche terminology in the target language. This research can even include regional variations.

Which Medical Documents Are a Priority

There is a multitude of uses for medical documents. They can inform the public on health matters, inform patients of treatment, obtain legal consent for procedures, and more.

You should consider the following criteria when deciding if a document needs translation (in compliance with Title VI. The Department of Justice).

  • How many individuals with Limited English Proficiency (LEP) need service.
  • The frequency of needed contact with a program.
  • What the nature of the program and its importance is to the program beneficiaries.
  • The resources available as well as associated costs.

It is commonly recommended that the following materials require translation.

  • Signage and informational posters that are visible in high traffic areas of a medical facility (such as the lobby).
  • “Vital” documents such as admission, consent, and complaint forms.
  • Eligibility, procedural, and safety materials.
  • Privacy forms and commonly given release instructions.
  • Important patient educational materials.

Mistakes to Avoid

Hiring a translator who is not properly trained in the medical field can lead to disastrous results. An unqualified translator is more likely to make mistakes when translating vital documents. Bilingual medical professionals should also not act as medical translators. Even if they have a level of fluency in a particular language, that proficiency is usually acquired at home, not through a formal education. It may be tempting to outsource your medical translation needs to technology, but the risks increase exponentially if machine translation is used. Machine translation may give a general understanding of the text it’s translating and even come to the rescue when there is need of a medical translation quickly in a medical setting and no qualified translators are readily available, but isn’t considered appropriate to produce any official medical documents. If a translation engine makes a mistake when working with medical text, the confusion and consequences caused by a misunderstood word can be serious.