Pharma Attorney Tokyo
Bridging Compliance Gaps to Amplify Pharma’s Competitive Strength

Global pharma compliance is multi-faceted. This includes regulatory adherence to Good Manufacturing Practice (GMP) and Quality Management Systems (QMS); medical compliance, notably on drug/medical device advertising, including off-label use; and regulations concerning the transfer of value and bribery laws such as the Foreign Corrupt Practices Act (FCPA) or Anti-kickback statute (AKS) for U.S.-based organizations.

A unified understanding of these compliance parameters is pivotal in today’s intricately intertwined pharma and life sciences landscape. When deciphered cohesively, this complex meshwork of rules becomes a clear roadmap for success.

Pharma Attorney Tokyo was born out of the pursuit to bridge these regulation gaps through its legal and compliance advice and support the materialization of a globally interconnected pharmaceutical ecosystem. It illuminates the path to navigating cross-border regulatory complexity, ensuring patient safety, promoting innovation, and driving sustainable international business expansion.

Its proficiency in traversing the disparities in regulations on the transfer of value and/or bribery is particularly noteworthy. Governed by Japan’s Fair Competition Code, it’s arguably the most challenging document to translate into English due to its stark contrast with regulatory concepts in the U.S., Europe, and other APAC countries.

The Architect of Pharma Attorney Tokyo’s Undertaking

Founder Yohei Kijima, a renowned attorney, is uniquely positioned to spearhead his company’s ambitious initiative.

Licensed to practice law in Japan and New York, U.S., and drawing on his experience as an in-house counsel for many global pharmaceuticals and medical device companies, Kijima has a profound understanding of international legal and compliance practices.

His strengths lie in his real-world experience and extensive network within relevant authorities and industry associations. For instance, his in-depth understanding of the Ministry of Health, Labor, and Welfare (MHLW), specifically with the Compliance and Narcotics Division (CNV), combined with his knowledge of past sanction cases, empower him with unparalleled insights into Japan’s regulatory framework. Equally deep knowledge of the U.S. compliance landscape, including the Department of Justice’s (DOJ) varying actions against pharmaceutical and medical device companies, enables him to offer valuable comparative analyses between the two nations. On that note, Corporate Integrity Agreements (CIA) established with the Department of Health and Human Services – Office of Inspector General (HHS-OIG) have become a foundational framework for many pharmaceutical and medical device companies. Kijima’s expertise makes him well-suited to effectively navigate these agreements, providing invaluable guidance to his global clients.

Kijima is also conversant with Europe’s regulatory environment and code compliance, particularly in the UK and France. His comprehension of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice, the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, the UK Bribery Act (UKBA), “Les entreprises du medicament” (LEEM) Rules of Professional Conduct, the “Loi Sapin II pour la transparence de la vie économique” (“Sapin II”), has helped him serve as a compliance intermediary for many clients.

Another feather to the cap is his role as the advisor to the Compliance Division of the Japan Pharmaceutical Industry Legal Affairs Association (IHOKEN), and his experience delivering lectures at their meetings further underscores his role as a trusted authority in the sector. His relationship with industry associations, such as the Japan Pharmaceutical Manufacturers Association (JPMA) and the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry (J-FTC), and involvement with the Japan In-House Lawyers Association (JILA) helps him maintain strong networks with the heads of legal and compliance or general counsel of pharmaceutical and medical device companies.

Opening Doors to Global Businesses

Pharma Attorney Tokyo’s expertise perfectly aligns with a foreign company trying to establish its presence in Japan. As Japan solidifies its position as the second-largest mature pharma market and emerges as a global epicenter of pharmaceutical innovation, foreign-headquartered companies, or gaishikei, are increasingly drawn to penetrate the market. But due to the language and cultural barriers, these companies often find the initiation process daunting. Kijima engages in direct dialogue with the CEOs, general counsels, and chief compliance officers, helping them set up operations in Japan. At times, he collaborates with their existing Japanese partners to guide them through the requirements from both resource and compliance perspectives.
Another pivotal part of the process involves assisting companies with pharma contract management. Companies typically design their contract programs according to the laws at their headquarters. However, these programs must be adapted to the Japanese legal and regulatory ecosystem when expanding into Japan.

Many of these businesses rely on law firms based in Hong Kong and Singapore—the legal hub of the APAC region—to address their challenges. However, due to the vast regional diversity within APAC, the lawyers are often not proficient in Japanese and encounter difficulties transitioning from an international perspective to one firmly rooted in the Japanese legal framework.

This gap extends to not just local branches of multinational corporations but Japanese businesses interacting with international companies or expanding outside Japan.

Pharma Attorney Tokyo meets these demands by thoroughly reviewing contracts across all business phases— encompassing research and development, manufacturing/quality, pharmacovigilance/safety, sales/marketing, and medical affairs. An indispensable conduit, it seamlessly integrates client business operations within the prevailing regulatory framework.

Aligning International Laws with the Japanese Fair Competition Code Regulations

For international companies, compliance programs mostly follow a U.S.-centric framework, such as the FCPA and HHS-OIG guidelines. Non-U.S. companies follow the IFPMA Code of Practice (or the EFPIA Code based on each European country’s IFPMA Code). Japanese compliance personnel’s unfamiliarity with these guidelines often proves challenging when traversing the nuanced requirements of Japan’s Fair Competition Code regulations and anti-corruption laws.

Pharma Attorney Tokyo proactively tackles these ambiguities through a multi-faceted approach incorporating general awareness and training, policy clarification, and rigorous oversight.

It begins by raising awareness about compliance among marketing authorization holders (MAH)—companies or individuals with the legal right to market and sell a pharmaceutical product in a particular jurisdiction. As per the 1st August, 2021 amendment to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, establishing a compliance program has become mandatory for MAH. Providing educational resources and training programs for their executives and emphasizing the consequences of non-compliance, not just in legal terms but in terms of the integrity of the company and its sustainable growth, helps foster a stronger culture of compliance.

Pharma Attorney Tokyo’s Expertise Perfectly Aligns with a Foreign Company Trying to Establish Its Presence in Japan

Elucidating the duties and interrelationships of ‘Responsible Officers,’ which include representative directors and other corporate directors overseeing regulatory matters, is the next mandatory step per the PMD Act amendment. This entails establishing corporate compliance programs that clearly define their duties based on an in-depth examination of the related legislation or guidance documents issued by the MHLW. When all involved parties fully understand their roles, the chances of misinterpretation or incorrect application of the law are minimized.

Pharma Attorney Tokyo also establishes clear lines of authority and supervision within companies. Under Ministerial Ordinances, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Quality Practice (GQP), Good Pharmacovigilance Practices (GVP), Good Post-marketing Study Practice (GPSP), Medical Device QMS, GMP, and Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP), companies must ensure designated personnel are empowered to correctly perform their duties. Clients are advised on the best practices for adequate supervision, including manufacturing, quality, and post-marketing safety control.

“These measures assist overseas companies in adhering to regulatory mandates and forestalling legal transgressions while simultaneously strengthening corporate integrity and promoting the company’s sustainable growth through diligent compliance,” says Kijima.

Navigating the Many Pharma Manufacturing Challenges

Pharma Attorney’s domain expertise helps many companies gain access to and apply industry best practices. For instance, time and again, the firm has skillfully harnessed the training materials issued by the pharmaceutical division of Osaka Prefecture— home to many leading pharmaceutical companies like Takeda, Shionogi, Ono, AstraZeneca, and Bayer—to assist other pharma manufacturing companies in refining their methodologies. Whether devising strategies for creating comprehensive legal compliance documents, forming compliance committees, or direct guidance for representative directors in developing reporting pathways, Pharma Attorney has consistently demonstrated an ability to unravel complex issues with out-ofthe-box thinking.

In one specific instance, these strategies proved instrumental in aiding a pharmaceutical company struggling with frequent work errors. The senior production manager identified two causes of these errors: a lack of experienced personnel and inadequate training. The problem was further complicated by a flaw in production planning, which didn’t account for potential delays in work, hampering the investigation and resolution process.

Pharma Attorney took multiple steps to help the company rectify the issues. A new legal compliance document was created to reinforce its top-level regulations, emphasizing its commitment to meeting regulatory standards. A compliance committee was also established to foster a company-wide culture of adherence to these standards. The move by responsible officers to become more active on the factory floor proved essential in boosting employee morale and providing insights into the company’s daily functioning.

Another situation where Pharma Attorney’s expertise was crucial involves a significant discrepancy uncovered within a major medical device manufacturer’s approval documents. Unauthorized changes to the raw material composition by a supplier led to inconsistencies between the approved and actual product materials. Such discrepancies posed serious risks, including potential regulatory penalties and damage to the company’s reputation. To address this issue, Pharma Attorney advised the company to structure the reporting pathways for management reviews, including details on frequency and content. This strategic approach helped in resolving the problem and also streamlined the information flow, expediting collaborative decision-making processes.

Strengthening Governance in the Wake of Violation Cases

Pharma Attorney Tokyo’s noteworthy contribution to fortifying governance through legal guidance and guest lectures has played a preeminent role in uplifting the pharma ecosystem of Japan’s Shizuoka prefecture—a well-recognized hub for pharmaceuticals and medical devices.

The prefecture has consistently showcased impressive production figures. It has topped the national pharmaceutical and medical device production value chart for 11 consecutive years.

However, amid the accolades, the prefecture is struggling with governance issues from a quality and compliance perspective. Kijima recently delivered a lecture touching upon these challenges, showcasing one of the many ways he has uplifted Japan’s regulatory compliance landscape.

A Promising Future

Kijima’s dream of fostering a healthy, sustainable pharma industry in Japan is steadily coming to fruition. Apart from his work at Pharma Attorney Tokyo, he is the founding director and senior consultant of Pharma Integrity Inc., where he aids pharmaceutical companies in establishing comprehensive compliance systems. This integrity-focused approach is critical to enhancing the competitive edge of companies, amplifying their corporate value, and promoting long-term social value within the pharmaceutical industry.

“Given the diverse compliance scenarios different firms face, my goal is to support the creation of enduring social values by attentively listening to companies and addressing their compliance perception and integrity gaps through tailor-made and best-suited advisory and support,” says Kijima.

Armed with extensive knowledge, Kijima prepares his clients to acknowledge their broader obligations. Maintaining pharma compliance is not only a fiduciary duty but a strategic priority that serves a company’s sustainable growth and larger societal good at the same time. With Kijima by their side, any pharmaceutical entity seeking success in an increasingly complex and highly regulated landscape is primed for it.

Spotlight on Kijima’s Contributions to Japanese Pharma Compliance

Kijima’s publications are a testament to his continuing efforts to boost the Japanese pharmaceutical and medical device regulations market.

“By providing bilingual books, I aim to bridge the language gap and make Japanese regulations more accessible to an international audience,” says Kijima.

His book, ‘Handbook of Japanese Regulations on Advertisement of prescription drugs (2020)’ provides comprehensive insights into Japan’s complex advertising regulations landscape. In the ‘Handbook of Japanese Regulations on Transfer of Value and Bribery to healthcare professionals (2021),’ Kijima delves into the intricacies of interactions between pharmaceutical companies and healthcare professionals, offering guidance on compliance and ethical practices. Its second edition of ‘Realization of Compliance in the Pharmaceutical Industry – Relevant Japanese Legal and Self-regulations and Case Laws’ explores the industry’s compliance concept, drawing from relevant Japanese legal frameworks and case studies. Another book, ‘Industry-based Q&A Book: Regulations on Pharmaceuticals & Medical Devices (2019),’ provides valuable answers to industry-specific questions, aiding legal professionals in navigating the regulatory landscape. Collectively, these books contribute to client knowledge, compliance, and success in the pharmaceutical industry in Japan.