Lack of braille labelling and instructions on Chinese pharmaceutical packaging

Abstract

Braille labels and instructions on medicine packaging are scarce in China, impeding blind individuals’ ability to obtain information about medications. Article 37 of China’s Barrier-Free Environment Creation Law, enacted in September 2023, requires braille labelling and instructions for pharmaceuticals. This provision offers essential legal protection to ensure the safety of blind individuals when using medications. Nevertheless, the use of braille labels and instructions for medicines is hindered by ambiguous statutes, limited social consciousness, financial factors and technological constraints. To promote the use of braille on medicinal labels and instructions, China should bolster its legislation, increase social consciousness, alleviate the financial strain on pharmaceutical manufacturers, foster technological advancement and encourage collaboration and self-governance within the pharmaceutical industry.

Keywords:

• Pharmaceutical labels
• medication instructions
• braille
• blind
• accessibility

Introduction

This is a current issue because the provision of accessible medication information, particularly through braille labels and instructions, is fundamental for ensuring the equitable access to healthcare for individuals with visual impairments. Despite the enactment of the Barrier-Free Environment Creation Law (BECL) in China, which mandates enhanced administrative standards for drug labels and instructions, the scarcity of braille packaging persists as a significant obstacle. In a global context where other regions, such as the European Union (EU), have implemented robust regulations for braille labelling on pharmaceuticals, the lack of comprehensive measures in China underscores a pressing need for immediate attention. Accessibility to medication information is not merely a matter of convenience but a vital aspect of upholding the rights to information, health, and life for blind and visually impaired individuals. Thus, addressing the deficiencies in current regulations and fostering awareness and implementation of braille labelling are imperative steps toward mitigating this pressing healthcare disparity.

BECL was implemented on September 1, 2023. Article 37(1) of the BECL states that relevant State Council departments must enhance administrative standards for drug labels and instructions. They must also ensure that drug manufacturers provide accessible versions of labels and instructions, such as audio, large print, braille and electronic formats. This provision aligns with the requirements of China’s constitution and the Law on the Protection of Persons with Disabilities, which aim to protect the equal rights of individuals with disabilities. The provision also demonstrates advances in establishing a barrier-free environment within China’s legal framework.

Concern about the accessibility of medications has garnered significant attention globally. Braille labelling of pharmaceuticals is widespread in the EU. In 2004, the EU implemented legislation outlining precise techniques for presenting medications intended for blind individuals. In 2009, the EU amended the guidelines to guarantee the requirements were effectively put into practise (European Commission 2009). At the legal level, the EU has stated that pharmaceutical makers have primary responsibility for guaranteeing the safety of medications for blind individuals. It is imperative that all medications available for purchase by individuals are equipped with braille labels.

The overall scarcity of braille labels and instructions on pharmaceutical packaging is a significant issue facing the Chinese pharmaceutical industry. Most Chinese pharmaceutical manufacturers have failed to implement the provisions outlined in the BECL. The absence of braille labels and instructions on medications poses a significant challenge for those with visual impairments, as it hinders their ability to access information regarding medications and their proper usage. This not only causes inconvenience in their daily lives but also infringes on their fundamental right to information. The absence of braille labels and instructions for medications in China is indicative of both the insufficiency of legislation and the lack of societal recognition regarding the needs of individuals with disabilities. It also represents a failure on the part of pharmaceutical manufacturers to fulfil their social obligation. Hence, it is imperative to evaluate the underlying causes of the absence of braille labels and instructions for medications in China and investigate potential avenues to address this issue.

Ambiguous statutes and regulations

Chinese pharmaceutical manufacturers and the National Medical Products Administration (NMPA) have initiated small-scale, experimental efforts enabling blind individuals to access drug information directly from standard drug packaging. One initiative involves the implementation of braille labelling on drug boxes. Since 2008, certain pharmaceutical manufacturers in China’s Zhejiang province have been attempting to include braille labels on medicine packaging, including China Resources Sanjiu, AstraZeneca (China) and Zhejiang Better Pharmaceuticals (Chen 2012). In addition, Zhejiang province approved regulation concerning braille labelling on medicine packaging to regulate and promote the practise of pharmaceutical companies engaging in public welfare activities. However, this regulation is a recommendation and does not include obligatory provisions. Very few medications have braille labels, and even fewer have braille instructions.

These efforts to implement braille packaging have been limited. The regulations established by the Zhejiang Medical Products Administration regarding braille labelling are only applicable within the jurisdiction of Zhejiang province. Most pharmaceutical manufacturers in other areas of China do not include braille labels on their medications. Furthermore, the regulation exclusively addresses the issue of braille labelling and does not mandate furnishing braille instructions. Consequently, the regulation remains insufficient in aiding blind people to utilise medications safely.

Attempts to make braille packaging more widely available have faced a multitude of challenges. As per the standard for medicine packaging and instructions outlined by the Good Manufacturing Practise for pharmaceuticals, additional labelling content on medicine packaging must be submitted to the NMPA for registration through a supplementary application process. The Chinese National Standards Packaging–Braille on Packaging for Medicinal Products, effective July 1, 2019, established China’s national standard for labelling on the external packaging of medicinal products, which was derived from the International Organisation for Standardisation standard ISO 17351:2013. However, the standard exclusively pertains to medicine labels and does not apply to medicine instructions. Medicine instructions in braille continue to face numerous challenges during the packaging registration process in China due to the absence of consistent standards for content, terminology, font size and other information.

Article 37 of the BECL lacks explicit measures for implementation (Liu 2023). The divergent interpretations of this provision among law enforcement agencies, judicial authorities and pharmaceutical manufacturers undermine the consistency of the legislation’s implementation. While China’s Regulations for Implementation of the Drug Administration Law mandates pharmaceutical manufacturers to include labels and instructions for medications, it does not require the provision of braille translations. In addition, current legislation does not regulate the precision and readability of braille information. As a result, pharmaceutical manufacturers face challenges in determining if their packaging adheres to the legal requirements.

Limited social consciousness

China has the highest prevalence of blindness globally, with an estimated one in every 100 individuals experiencing it (Xu and Chen 2018). However, Chinese society exhibits a profound lack of knowledge regarding the needs of individuals who are blind. For pharmaceutical manufacturers, addressing the needs of blind people is considered an ancillary responsibility rather than a fundamental duty, and they are therefore hesitant to allocate resources towards braille labelling and instructions. In the pharmaceutical industry, there is a lack of comprehension among manufacturers and other relevant parties regarding the unique needs of blind individuals. Thus, insufficient attention is given to incorporating these needs into the design and production process of pharmaceutical packaging.

Chinese pharmaceutical manufacturers implicitly assume that blind individuals require the assistance of non-blind individuals, thus exhibiting inadvertent bias. When pharmaceutical manufacturers assume this, they disregard the importance of providing access to information for blind people. There are other factors that contribute to this bias as well. Pharmaceutical manufacturers and regulatory authorities have not adequately studied the medication habits, purchasing behaviour and ability to access information of blind individuals. Furthermore, blind individuals in China lack readily accessible means of providing feedback to pharmaceutical manufacturers and regulatory authorities and are thereby prevented from effectively articulating their needs. Consequently, Chinese society has neglected the needs of blind and visually impaired people when it comes to the design of pharmaceutical labels and instructions.

This lack of awareness impacts blind individuals’ access to clear and effective information. Most Chinese medical practitioners are unaware of the contents of the newly enacted BECL or of the distinct features of Braille, which has unique language conventions and requires specialised knowledge. Because Chinese pharmaceutical manufacturers often lack knowledge of braille spelling rules and do not possess the necessary equipment to print braille, the manufacture of braille labels and instructions has not been incorporated into the standards and procedures of medicine manufacturing.

Financial factors

To include braille labels and instructions on packaging, pharmaceutical manufacturers must incur higher production expenses. In China, this means a packaging cost increase of three to five percent by adding braille labels, while incorporating braille instructions generates additional production expenses (Health China 2014). Pharmaceutical manufacturers prioritise maximising earnings and minimising production expenses and typically prioritise short-term financial gains over long-term societal responsibilities. Investing in braille labels and instructions is unlikely to yield substantial short-term returns for pharmaceutical manufacturers, making it less attractive from a financial perspective.

Pharmaceutical manufacturers must take on a variety of costs to add braille labels and instructions to medicine packaging. First, they must acquire novel manufacturing machinery, such as braille printers. Second, they must implement changes to expedite the drug manufacturing process, which can lead to an initial decrease in productivity and output. Third, they must absorb the expenses associated with the transportation and distribution of the medications, as braille labels and instructions for medications have sizable dimensions and demand high-quality printing materials. Finally, they must provide training in braille to current employees or recruit new employees with braille expertise. To compensate for these additional expenses, pharmaceutical manufacturers may pass the cost on to consumers by raising the prices of medications.

Technological constraints

The technological foundation for braille medical labels and instructions in China is comparatively antiquated. Braille printing necessitates specialised equipment and technical assistance, including braille printing presses, design software and digitisation technologies. Most Chinese pharmaceutical manufacturers do not possess the necessary technological infrastructure, rendering them incapable of manufacturing braille labels and instructions.

Braille is a tactile script designed for blind or visually impaired individuals with a distinct set of grammar rules. Thus, the creation of braille labels and instructions requires the designer to possess a comprehension of braille symbols, structure and syntax, in addition to the relevant medical expertise. Design talents of this calibre are rare. Medicines also possess certain characteristics that set them apart from other goods. Mistakes on braille labels or instructions for medications can pose a direct threat to the health and safety of blind individuals, making the role of the designer even more critical.

The design of labels and instructions is influenced by several factors, such as the arrangement, legibility, precision and ease of displaying braille information on drug packaging. Pharmaceutical manufacturers must establish efficient data processing and management systems to guarantee the precision and uniformity of braille information. Additionally, they should incorporate and adapt accessibility technologies to ensure that the information is accessible and comprehensible.

Concluding remarks

The use of braille labelling and instructions for medications is crucial for ensuring the safety of individuals who are blind or visually impaired. The enactment of the BECL is beneficial for protecting the fundamental rights of blind and visually impaired people. Enacting a law to mandate braille labels and instructions for medicines is also likely to raise awareness within Chinese society regarding the importance of this matter. However, legislative provisions are insufficient on their own. China must enhance its legislative framework and bolster enforcement efforts. The Chinese government and drug industry groups should prioritise the promotion of braille labelling and instructions throughout society by conducting awareness campaigns and providing legal education. The Chinese government should also offer financial incentives to pharmaceutical manufacturers to offset costs and motivate companies to assume responsibility for providing care for blind and visually impaired people. Finally, pharmaceutical companies and technology firms have the potential to create innovative digital technologies and applications that enhance the safety and convenience of medication for blind individuals. By implementing various strategies, these organisations can ensure the fundamental rights of people who are blind and visually impaired, including the rights to information, health and life.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work is supported by Major Research Project on Philosophy and Social Science Research, Ministry of Education of the People’s Republic of China (Grant Number 22JZD017) and Teaching Reform Project of Shenzhen University of Technology (Grant Number 20241046).