Life Sciences 2024 Comparisons

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the “Pharmaceuticals Law”), together with related cabinet and ministerial orders, is the primary law that governs pharmaceuticals and medical devices in Japan.

The Ministry of Health, Labour and Welfare (MHLW) is the principal regulatory body for pharmaceuticals and medical devices. The MHLW is the national government body that issues most of the Pharmaceuticals Law-related ministerial orders and administrative guidelines, and drafts relevant cabinet orders. Prefectural governments (ie, independent local governments such as the Tokyo Metropolitan Government) are primarily responsible for monitoring pharmaceutical and medical device marketers, manufacturers and distributors in their respective jurisdictions on behalf of the MHLW. The Pharmaceuticals and Medical Devices Agency (PMDA), a Japanese independent administrative agency that receives financial support from the Japanese government to cover its operational costs, also plays a key role in reviewing marketing authorisation applications for new pharmaceutical and medical devices.

If a pharmaceutical or medical device firm violates the Pharmaceuticals Law or any related regulation, the MHLW or a prefectural government may issue an administrative order to that firm. The recipient may challenge the administrative order through an administrative complaint review process provided under the Administrative Complaint Review Act. A pharmaceutical or medical device firm served with an administrative order may also commence a legal action for the revocation of the administrative order with a competent court in accordance with the Administrative Case Litigation Act. These challenge procedures are also generally applicable in cases involving the issuance of administrative orders for violations of laws concerning other regulated products (eg, certain food products). Recently, a few leading generic drug manufacturers received business suspension orders due to their violations of pharmaceutical regulations, resulting in significant shortages in certain sectors of the generic drug market in Japan.

Pharmaceuticals are categorised into two classes: prescription pharmaceuticals and OTC pharmaceuticals. Prescription pharmaceuticals may only be used by doctors or used in accordance with a doctor’s prescription. OTC pharmaceuticals can be purchased at drug stores or other non-licensed stores. OTC pharmaceuticals are further classified into several sub-categories and, depending on the relevant sub-category, may have certain sales restrictions – for example, a requirement that they be sold only at establishments at which a pharmacist (or other designated licensed personnel) is present.

Medical devices are categorised into three classes:

• specially controlled medical devices (classes III and IV of the Global Harmonisation Task Force (GHTF) international classification structure);
• controlled medical devices (class II of the same); and
• ordinary medical devices (class I of the same).

Depending on the relevant class of medical devices, a marketer and a distributor will need to obtain different business licences, as appropriate.

The Pharmaceuticals Law, together with the Good Clinical Practice (GCP) ministerial order issued by the MHLW, is the principal law regulating clinical trials. The MHLW and the PMDA are the main regulatory authorities that oversee clinical trials.

Japan requires all drugs to be tested through clinical trials and approved for marketing in Japan. Even new drugs that have undergone clinical trials and received marketing approval in foreign jurisdictions are required to undergo separate clinical trials in Japan in order to verify such drug’s effectiveness and safety when given to Japanese people. Even for COVID-19 vaccines supplied to Japan, the Japanese government required that a limited number of separate clinical trials be performed in Japan based on this policy.

To conduct a clinical trial, an applicant (a pharmaceutical or medical device marketer) must prepare a protocol and receive approval for such protocol from an institutional review board (IRB). The applicant is also required to register the protocol with the MHLW through the PMDA. In practice, the applicant consults with the PMDA informally about its draft protocol before formally registering the protocol with the MHLW.

The website of the National Institute of Public Health discloses certain basic information regarding clinical trials conducted in Japan, including:

• the title of the study;
• the subject material of the study;
• a brief summary of the study;
• information about the monetary sponsor, the relevant IRB, and other organisations involved;
• contact information for the parties involved; and
• a summary of the results.

There is no apparent prohibition on using online tools to support clinical trials. Clinical trials are generally required to be conducted by doctors or hospitals and include in-person interviews with, and written informed consents from, clinical trial subjects. Recruiting clinical trial subjects can be conducted online. In addition, under a guideline from the MHLW, if an approved protocol for a clinical trial provides for online medical checks in the clinical trial, such medical checks can be conducted on an online virtual examination basis.

Raw data obtained from clinical trials is considered to be sensitive data of clinical trial subjects. Therefore, clinical trial data obtained by a doctor or hospitals (investigators) is usually converted into a form that prevents the identities of clinical trial subjects from being discoverable and only such anonymised information or data is provided to the sponsor of the clinical trial. Furthermore, upon commencement of a clinical trial, investigators must obtain an informed consent letter from each trial subject regarding the use and treatment of such subject’s sensitive personal data.

As mentioned in 2.5 Use of Data Resulting From Clinical Trials, it is common practice for resulting data to be anonymised, and in such form the data is not regulated as strictly as sensitive data. Disclosure of original, non-anonymised data (raw data) is heavily regulated as sensitive information under the Act on the Protection of Personal Information (APPI).

The term “pharmaceutical” is defined under the Pharmaceuticals Law as:

• items listed in the Japanese Pharmacopoeia;
• items that are intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals; or
• items that are intended to affect the structure and functioning of a human’s or animal’s body.

However, quasi-pharmaceutical products and cosmetics are excluded from the definition of pharmaceutical.

The term “medical device” is defined under the Pharmaceuticals Law as appliances, instruments or similar items that are intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals – or that are intended to affect the structure or functioning of the bodies of humans or animals – and that are specified by cabinet order.

The relevant cabinet order specifying medical devices is so broadly worded that it is not clear whether each and every medical appliance, instrument or similar item is classified as a medical device. Software that is intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals can also be classified as a medical device.

To market a pharmaceutical or medical device, the initial marketer is required to obtain marketing authorisation. Key factors that are taken into account when reviewing an application for marketing authorisation or marketing certification are:

• the quality, effectiveness and safety of the pharmaceutical or medical device;
• the applicant’s marketing business licence;
• the manufacturer’s manufacturing business licence; and
• the manufacturer’s compliance with the good manufacturing practice (GMP) regulation.

To obtain marketing authorisation for a biological pharmaceutical, certain additional requirements must be fulfilled, such as:

• a manufacturer of a biological pharmaceutical must comply with more stringent management and safety requirements; and
• packaging/packaging inserts of a biological pharmaceutical must indicate that it is a biological product.

The period of validity of a marketing authorisation is not indefinite. Depending on the type of medical product, an authorisation for a new pharmaceutical is generally subject to re-examination four to ten years after the initial authorisation. Additionally, the MHLW occasionally conducts a re-evaluation of pharmaceuticals based on the recommendation of its advisory board.

A marketing authorisation can be revoked by the MHLW and other competent authorities. A marketing authorisation can be revoked when, for example, it is found that:

• the relevant pharmaceutical does not have the efficacy or produce the effects indicated in the application; or
• the relevant pharmaceutical has no value because the harmful effects associated with such product outweigh the efficacy or beneficial effects.

Additionally, a marketing authorisation can be revoked if the responsible party has not marketed the relevant authorised pharmaceutical or medical device for three consecutive years without any reasonable justification. The MHLW may vary parts of a marketing authorisation for pharmaceuticals and medical devices if, in the MHLW’s view, it is necessary to do so in light of health or hygiene considerations.

Submission of Application

An application for marketing authorisation must be submitted to the MHLW or – in the case of certain pharmaceuticals and all medical devices (other than medical devices with a GHTF classification of class IV) – to the relevant prefectural government or a particular registered certification body. With regard to an application for a pharmaceutical or medical device that must be submitted to the MHLW, the application must be submitted through the PMDA. The MHLW’s review of applications for marketing authorisation for new medicinal products is substantially outsourced to the PMDA. Once the PMDA is satisfied with the application, the application is forwarded to the MHLW, which then obtains a recommendation from the Council of Pharmaceutical and Food Sanitation before approving the application.

Required information

A marketing authorisation application must include, as an attachment, data concerning the results of clinical trials and other pertinent data – except where the application is for a medicine that is subject to a conditional early approval for market authorisation (an expedited process).

Variation of a marketing authorisation

Variation of a marketing authorisation – such as a change in the therapeutic indication, formulation, dosage, patient population, packaging or labelling – requires the marketing authorisation-holder to complete a formal process. Depending on the materiality of the change, the variation may require approval from the relevant authority or the mere submission of a report.

Transferral of a marketing authorisation

It is permissible for market authorisation to be transferred from the current marketing authorisation-holder to a transferee. A transferee of a marketing authorisation must notify the relevant authority of the transfer at least one month prior to the date of transfer.

The Pharmaceuticals Law provides for an exceptional procedure to allow the importation of a pharmaceutical or medical device that has received foreign marketing authorisation for compassionate use if:

• the foreign marketing authorisation was obtained in a country with a marketing authorisation system equivalent to the system in Japan;
• immediate use of the pharmaceutical or medical device is necessary to prevent a pandemic that could cause death or serious harm to the health of Japanese citizens; and
• the pharmaceutical or medical device is specifically designated under an administrative order.

This special procedure was once used to import an influenza vaccine produced by a foreign manufacturer. It is also used for vaccines and therapeutic drugs for COVID-19 that are produced by foreign manufacturers and supplied for use in Japan.

After the marketing of a pharmaceutical or a medical device commences, the marketing authorisation-holder is required to conduct post-marketing pharmacovigilance and technovigilance. If any issue relating to the effectiveness or safety of the marketed pharmaceutical or medical device is discovered during the post-marketing authorisation surveillance period, the marketer must conduct a pharmaceutical or medical device recall campaign, report the discovery to the PMDA, issue public notices, and take other appropriate measures to prevent patients suffering further damage or losses.

An applicant for a marketing authorisation must typically complete all clinical trials first and then submit its application with the complete accompanying data. However, in the case of conditional early approval for market authorisation for an innovative product exempted for a part of its clinical trials, post-marketing phase IV clinical trials must be performed.

In general, third parties can access information about applications for marketing authorisations by making a request under Japan’s information disclosure law. Under the Act on Access to Information Held by Administrative Organs, anyone may request the disclosure of administrative documents held by an administrative organ.

Under this law, the MHLW is essentially required to disclose an application for marketing authorisation if properly requested. However, the application may include or refer to the IP or confidential information of an applicant, and the disclosure of such information to a third party may result in serious damage to an applicant’s rights and competitiveness. Therefore, disclosure of an application is usually made after the relevant sensitive information contained in it has been redacted or masked.

To market a pharmaceutical or a medical device, the initial marketing entity must obtain marketing authorisation for the pharmaceutical or medical device under the relevant regulation. Falsification or illegal distribution of pharmaceuticals or medical devices (including distribution by a party without first having obtained marketing authorisation) are violations of this regulation. The MHLW may order the responsible party to recall all such falsified or illegal products from the market, impose administrative sanctions against such responsible party, and even refer the violation to the public prosecutor for investigation and potential prosecution for criminal sanctions.

With regard to counterfeit pharmaceuticals and medical devices, the owner of an infringed patent or other IP right can file an application for an importation suspension of counterfeit products with the Japanese customs authorities. The IP rights-holder may also file an application for an import ban or provisional disposition order, or file a lawsuit with a court in Japan seeking similar relief.

Pharmaceutical Manufacturers

A manufacturing business licence is required in order to manufacture pharmaceuticals in Japan. If a manufacturer of an imported product is located outside Japan, said manufacturer will be required to obtain accreditation as a foreign manufacturer. A manufacturing business licence is granted by the relevant prefectural government and such accreditation is granted by the MHLW. Once an application for a manufacturing business licence is formally submitted, the prefectural government reviews the application and – in most cases – conducts an on-site inspection of the applicant’s manufacturing premises. The period of validity of a manufacturing business licence and an accreditation is five years.

Medical Device Manufacturers

Unlike pharmaceutical manufacturers, a medical device manufacturer – whether located in Japan or outside Japan – is only required to satisfy a prior registration (ie, registration with the MHLW as a medical device manufacturer). The registration must be renewed every five years.

In order to market pharmaceuticals or medical devices, the initial marketing entity must hold a marketing business licence and have marketing authorisation for each of the relevant products. A marketing business licence is granted by the relevant prefectural government. Once an application for a marketing business licence is formally submitted, the prefectural government reviews the application and – in most cases – conducts an on-site inspection of the applicant’s office or factory.

Marketing business licences are generally valid for five years; however, the actual validity period will depend on – among other things – the type of pharmaceutical or medical device to be distributed by the applicant. Wholesalers and retailers of pharmaceuticals and medical devices are also required to obtain a distribution business licence.

There are two types of marketing business licences for pharmaceuticals: Type 1 and Type 2. A Type 1 marketing business licence is required for marketing prescription pharmaceuticals. A Type 2 marketing business licence is required for marketing other pharmaceuticals (ie, non-prescription ethical pharmaceuticals and OTC pharmaceuticals).

There are three types of marketing business licences for medical devices:

• a Type 1 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class III or IV;
• a Type 2 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class II; and
• a Type 3 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class I.

The Pharmaceuticals Law governs the import and export of pharmaceuticals and medical devices. Imports of pharmaceuticals and medical devices from outside Japan are, in principle, subject to the same marketing regulations applicable to products manufactured in Japan. Importers of these products are subject to requirements regarding marketing authorisation, marketing business licences and accreditation as a foreign manufacturer.

A manufacturing business licence is required for the manufacture of pharmaceuticals or medical devices that are to be exported from Japan. Although marketing authorisation is not necessary, a separate registration for manufacturing pharmaceuticals or medical devices for export is required.

The relevant prefectural government regulates marketing business licences, whereas the MHLW regulates accreditations for foreign manufacturers.

An importer of pharmaceuticals or medical devices must obtain a marketing business licence, except in the case of the importation of small amounts of these products by an individual for their personal use. An importer must present certificates of the marketing business licence and the marketing authorisation for each particular imported product to the relevant customs house.

Importation of pharmaceuticals or medical devices is not permitted unless the importer on record possesses a marketing business licence and a marketing authorisation for each particular imported product – except where small amounts of these products are imported by an individual for their personal use. As regards permitted exceptions in the case of emergency situations, see 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations.

In addition to obtaining a marketing business licence and marketing authorisation when importing pharmaceuticals or medical devices, it may be necessary to change the product’s packaging to conform to product description information and requirements provided under the relevant marketing authorisation. By way of an example, packaging and product labelling – and the explanatory written material provided with the products (such explanatory information is usually available online) – must be provided in Japanese and satisfy the requirements under the relevant marketing authorisation. Changing a product’s packaging is considered part of the manufacturing of the product and, as such, the entity responsible for performing such changes is required to possess a manufacturing business licence.

As of December 2023, Japan has signed 21 economic partnership agreements/free trade agreements with other countries. Among others, Japan is a signatory to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP).

Prices for the substantial majority of medical services provided and prescription pharmaceuticals sold in Japan are reimbursed by the Japanese universal healthcare system, and the substantial majority of legal residents of Japan participate in and are covered by Japan’s national health insurance system. The cost of prescription pharmaceuticals to be paid through the national health insurance system corresponds to the prices for the relevant pharmaceuticals listed on the drug tariff.

Listing of a prescription pharmaceutical’s price on the drug tariff is based on the Health Insurance Act and is a separate procedure from the marketing authorisation procedure provided under the Pharmaceuticals Law. The profit margin of the hospitals and the pharmacies is usually the difference between the prices at which the pharmaceuticals are purchased by the hospitals and the pharmacies (such price is usually lower than the price listed on the drug tariff) and the prices at which the products are sold by the marketer of prescription pharmaceuticals.

The listing of pharmaceuticals on the drug tariff and the price designated for each of the pharmaceuticals listed are determined by the MHLW after reviewing the applications submitted by the market authorisation-holders of such pharmaceuticals. The price of the same product in other countries is one element of background information considered when determining the listing price. The drug tariff is reviewed and updated basically every two years.

A substantial part of the costs of pharmaceuticals and medical treatments is covered by the health insurance scheme. For the majority of Japanese residents, 70% of these costs are covered by health insurance.

The MHLW considers cost-benefit analysis as a key factor when evaluating new pharmaceuticals.

Historically, Japanese hospitals prescribed and dispensed pharmaceuticals themselves. However, in an effort to address excessive pharmaceutical-related spending, the MHLW began incentivising hospitals to separate the prescription and dispensing of pharmaceuticals functions so that pharmaceuticals are not prescribed unnecessarily.

The parts of software in medical hardware devices used for data processing are categorised as medical devices. Depending on its function, purpose, data-processing results and other factors, a software application (or relevant parts thereof) designed to run on a smartphone, tablet or other similar device may be categorised as a medical device if it is intended for use in the diagnosis, treatment or prevention of disease in humans.

As a general principle, the law essentially requires medical diagnosis to be performed by a physician through a face-to-face consultation with a patient. However, a guideline issued by the MHLW provides guidance on the permissible scope of telemedicine services and legitimises the provision of such services in cases where conducting a face-to-face consultation would be practically difficult or where such services are to be provided for a patient with a chronic – yet stable – condition. Under the MHLW guideline, it is generally required that physicians using telemedicine for initial consultations with the patient be primary care physicians who are familiar with the subject patient.

Regulations addressing the promotion or advertising of pharmaceuticals and medical devices apply equally to online promotion and advertising (eg, through online portals, company web pages and social networking websites). An advertiser’s web page containing hyperlinks to other web pages may be considered collectively as a single advertisement and, as a whole, may violate regulations concerning advertisements – even if each web page on its own would not violate these regulations.

The MHLW has issued a guideline addressing electronic prescriptions, which emphasises the merits of these. The issuance of electronic prescriptions through email is prohibited, given the risks associated with transmission of information electronically – for example, unintentional information disclosures or unlawful theft of information. The MHLW promotes the use of electronic prescriptions through an online management system administered by the national health insurance payer, which commenced operations in January 2023.

Almost all OTC pharmaceutical products are marketable online, with the exception of certain potent pharmaceuticals and OTC pharmaceuticals that were formerly classified as ethical pharmaceuticals (a classification that typically indicated a prescription was required).

The use of electronic health records is an accepted practice in Japan and almost all large hospitals have adopted the use of these records, with smaller hospitals following their lead. Health-related information generally falls within the scope of “sensitive data” as defined under the APPI and is subject to stricter regulations. A person will, in principle, not be allowed to obtain sensitive data concerning an individual unless the individual’s consent has been obtained.

The APPI requires appropriate security measures to be implemented for the handling of personal data. A specific guideline has been published regarding:

• the use of cloud platforms in relation to medical data; and
• the security measures to be implemented for the protection of medical data stored on such cloud platforms.

The transferral and storing of patients’ sensitive data on cloud platforms is generally not prohibited, provided the relevant cloud platform meets and complies with the various requirements set out in the specific guideline.

The Patent Act is the primary law that applies to patents. The Patent Act allows for patent term extensions for pharmaceutical patents and, as a result, commonly encountered issues include:

• whether or not a pharmaceutical patent qualifies for a patent term extension; and
• the extent to which protections under the Patent Act continue to apply in the case of a patent term extension.

As regards the issuance of patents, there are no requirements that relate specifically or exclusively to pharmaceuticals or medical devices.

The novelty of a pharmaceutical invention (a requirement for a patent to be granted for such invention) is generally judged based on the following two points:

• a compound having a specific attribute; and
• a medicinal use based on such attribute.

Accordingly, second and subsequent medical uses of a known pharmaceutical product can be granted patents if the relevant usage is considered novel and other relevant conditions and requirements are satisfied.

In this respect, medicinal use includes new dosage regimes and new or selected patient populations, and therefore can be patented if considered novel. Second and subsequent patents of pharmaceutical products can be infringed if the patented invention is exploited by a third party without authorisation during the term of the patent – for example, if a patented product is sold for the patented use without authorisation from the relevant patent-holder.

For patented pharmaceuticals, the term of the patent can be extended upon request by the patent-holder to the Japan Patent Office, and the fulfilment of relevant procedures. The term of the extension, which cannot exceed five years, is generally equivalent to the period of time during which the patent-holder was prevented from exploiting the invention while awaiting medicinal product approval in accordance with the Pharmaceuticals Law. Patent term extensions can be challenged by third parties – for example, a third party may commence a legal proceeding with the relevant court seeking invalidation of a patent term extension registration.

Infringement of a registered pharmaceutical or medical device patent occurs when a person exploits the patented invention during the term of the patent without the patent-holder’s permission. This includes, for example, the unauthorised production, usage, sale, import or export of a patented product. The Patent Act provides for injunctive relief as a remedy that can be sought where there is an imminent threat of infringement, as opposed to the occurrence of actual infringement. In order for injunctive relief to be granted by a court, the threat of infringement must be present from an objective standpoint.

Protections established by a patent do not restrict exploitation of the patented invention for experimental or research purposes. Accordingly, experimental use can be asserted as a defence to a claim of patent infringement in relation to pharmaceuticals and medical devices. The Patent Act provides for the granting of compulsory licences to patents in certain situations, including – but not limited to – patents for pharmaceutical products and medical devices. A compulsory licence can be granted by the Commissioner of the Japan Patent Office in prescribed cases, such as where a patented invention has not been exploited in Japan for three years.

If a patent is infringed or there is a present threat of infringement, the patent-holder can seek injunctive relief through a civil court proceeding to force the infringing party to cease and desist and to destroy infringing articles. The patent-holder can also assert a monetary compensation claim in a civil court proceeding against the infringing party for damages that it incurred from the infringement.

The Patent Act includes special provisions intended to facilitate a patent-holder’s recovery of damages incurred by the infringement of its patent. By way of an example, under the Patent Act, a person who infringes a patent is presumed to have acted negligently in relation to the infringement. This presumption shifts the burden of proof from the patent-holder to the infringing party; therefore, in order for the infringing party to prevail, it must prove that there was no negligence on its part in relation to the infringement. Invalidity of the subject patent is an available defence and can be asserted in patent infringement litigation.

In order for the producer of a potential generic entrant to establish that the action it proposes to take is lawful under patent law, it may initiate litigation against the patent-holder of the relevant brand-name pharmaceutical in order to obtain a court decision confirming the non-existence of a patent infringement claim based on the generic market entry. However, obtaining a court order through this type of lawsuit is not a requirement for generic market entry under the Japanese pharmaceutical regulations. It is generally considered that the existence of a potential patent infringement claim is taken into account when undergoing the marketing authorisation examination procedure.

The Pharmaceuticals Law prohibits the sale of counterfeit drugs and medical devices. As such, violators will be subject to criminal penalties. In addition, counterfeit drugs and medical devices may infringe registered trade marks and possibly registered patents. Furthermore, the import and export of IP-infringing goods may be illegal, and violators will be subject to criminal penalties. Criminal investigations of possible violations are typically conducted by the police. The import and export of infringing goods is policed by the Japanese customs authorities.

There are no specific restrictions on the trade marks that can be used for pharmaceuticals or medical devices under the Trade Mark Act. In general, a medicinal product brand can be registered as a trade mark. There are a number of excluded categories of marks that cannot be granted trade mark rights or protections, such as a sign that:

• is the same as, or similar to, a national flag;
• is deceptive or contrary to public policy; or
• is not legally distinguishable from:
1. signs or marks used to identify widely recognised brands; or
2. other trade marks that were filed earlier.

The owner of an infringed IP right, including a trade mark owner, can seek to suspend the import or export of counterfeits that infringe its IP right by filing an application for suspension with the Japanese customs authorities.

IP protection is available for trade dress and designs of pharmaceuticals and medical devices, as well as their packaging. Trade dress and designs can be registered and protected as trade marks under the Trade Mark Act. The Trade Mark Act stipulates a number of legal criteria to be met in order to register a trade mark, including the requirement that the relevant mark or sign is capable of distinguishing the subject goods or services from those of other manufacturers or merchants or service providers.

There is no data exclusivity available under Japanese law for pharmaceuticals and/or medical devices. An abridged procedure for obtaining marketing authorisation for generic drugs is not available until the re-examination period for the original drug has expired. This effectively operates as a time barrier that prevents a generic drug product from receiving marketing approval until such re-examination period for the original drug has expired. The same re-examination period rules apply for chemical drugs and biologics.

The MHLW has announced that it will prioritise the review of marketing authorisation applications for medicines and medical devices to be used for the treatment of COVID-19. The MHLW will also consider measures to streamline the process by reducing and facilitating the preparation of application materials for such medicines and medical devices. Amendments were made to relevant Japanese rules in order to broadly abolish various regulatory filing requirements that mandated the submission of documents in hard copy with the company seal affixed thereto.

The MHLW has issued guidance addressing various special measures that can be taken in relation to clinical trials for the COVID-19 pandemic. The MHLW guidance sets out criteria to allow for, among other things, delivery of the test drug to the test subject’s residence by mail, alternatives to in-person institutional review board meetings, alternatives to on-site trial monitoring, and the use of telemedicine in clinical trials.

The Pharmaceuticals Law provides for a special emergency approval process whereby the MHLW may grant exceptional approval for pharmaceuticals and medical devices developed to address an urgent need relating to the prevention of the spread of disease or other health hazards that may pose a serious threat to the lives and health of the general public, where no suitable alternative is available other than the use of such pharmaceuticals/medical devices. In order to be granted this exceptional approval, the pharmaceuticals/medical devices must either:

• be presumed to have the efficacy or effects indicated in the application (and not be presumed to have no value as pharmaceutical/medical device products, owing to harmful effects that outweigh their efficacy or effects); or
• be authorised to be marketed in a foreign country (provided the foreign country’s marketing approval system is recognised by the MHLW as being substantially equivalent to Japan’s marketing approval system in terms of assessing the quality, efficacy, and safety of the pharmaceuticals/medical devices).

The MHLW has granted marketing authorisation through the exceptional emergency approval process for Remdesivir, a medication that may be used in the treatment of COVID-19.

During the COVID-19 pandemic, various regulatory filing and inspection processes relating to manufacturing business licences for pharmaceuticals and medical devices were revised to allow for electronic processing. Additionally, amendments were made to relevant Japanese rules in order to broadly abolish various regulatory filing requirements that mandated the submission of documents in hard copy with the company seal affixed thereto.

In March 2020, the MHLW announced that it would permit companies to import disinfectant products produced outside Japan for use within their companies to protect employees from COVID-19. This announcement was made as a measure to:

• address the significant increase in demand for disinfectants due to the COVID-19 pandemic; and
• allow Japanese companies to procure, from outside Japan, the supplies of disinfectant products necessary for the continuation of their business operations.

The MHLW took measures to facilitate the use of telemedicine services in Japan during the COVID-19 pandemic. As mentioned in 8.2 Rules for Telemedicine, initial consultations between physicians and patients were generally not permitted to be conducted online prior to the pandemic. However, this prohibition was temporarily suspended during the COVID-19 pandemic, and telemedicine services were broadly permitted from the initial consultation.

The Patent Act allows for compulsory licensing in cases where the implementation of a patented invention is especially necessary in the public interest. In such cases, a person may request the patentee to participate in consultations concerning the granting of a non-exclusive licence to use the patented invention and may further request an order from the Minister of Economy, Trade and Industry for an order compulsorily granting a non-exclusive licence to use the invention for a specified purpose. There have been discussions on whether compulsory licences under the Patent Act should be granted to ensure a stable supply of products used for COVID-19 treatments; however, no such compulsory licence has been granted thus far.

In December 2020, the Japanese government enacted an amendment to the Immunisation Act, thereby allowing the government to enter into contracts with vaccine manufacturers and agree to indemnify the manufacturers for losses incurred from compensating victims who sustained harm to their health after receiving the manufacturer’s COVID-19 vaccine in Japan. Based on this provision, the Japanese government has reportedly been negotiating indemnification agreements with pharmaceutical companies that are to supply COVID-19 vaccines to Japan.

Despite the measures put in place by the government concerning compensation for vaccine recipients who sustained health-related harm, and pharmaceutical company indemnification for damages attributable to COVID-19 vaccinations in Japan, Japanese law does not grant immunity to pharmaceutical companies supplying COVID-19 vaccines. Consequently, vaccine recipients are not precluded from asserting claims directly against these pharmaceutical companies for damages attributable to the harm their health suffered from the vaccine.

In the event that the Japanese government declares a state of emergency in response to COVID-19, the government can designate individual manufacturers of pharmaceuticals and medical devices and require the designated manufacturers to take the necessary measures to ensure continued manufacturing and sales of specified pharmaceuticals and medical devices. It is generally considered that the measures contemplated to be taken by the designated manufacturers would typically include measures necessary for ensuring the prevention of COVID-19 infection and an adequate supply of pharmaceuticals and medical devices for COVID-19 treatment. The Japanese government declared a state of emergency from April to May 2020, from January to March 2021, and from April to September 2021, respectively.

Pursuant to a recent amendment, the Japanese government is able to request that manufacturers promote and co-operate with the manufacturing of pharmaceuticals and medical devices if a shortage of product could make it difficult to prevent the spread of infectious disease and this could materially affect the lives and health of the Japanese people.

As is the case in other countries, the Japanese government has actively sought to procure stocks of COVID-19 vaccines from various vaccine-producing pharmaceutical companies so that the administration of vaccines can be implemented in Japan. According to press reports, the Japanese government has entered into agreements with Moderna and Takeda Pharmaceutical, as well as with AstraZeneca and Pfizer, for the procurement of COVID-19 vaccines.