All matters pertaining to pharmaceuticals and medical devices are governed by the Drug and Pharmacy Law No 12 of 2013 and the regulations and directives that are issued pursuant to it.
The national regulatory authority in charge of applying and enforcing these regulations in Jordan is the Jordan Food and Drug Administration (JFDA) and its respective directorates and divisions. In addition to drugs, the jurisdiction of the JFDA covers:
Pursuant to the Food and Drug Administration Law No 41 of 2008, the JFDA is an independent public sector regulatory institution with financial and administrative independence. The JFDA is managed by a board of directors, consisting of:
The Director General of the JFDA is appointed pursuant to a decision of the Council of Ministers upon the recommendation of the Minister of Health, provided that this appointment decision is accompanied by a Royal Decree. The JFDA has an independent budget, and its financial resources consist of the following:
The JFDA enjoys the same exemptions and facilities granted to ministries and governmental departments and its funds are considered public funds.
Decisions of the JFDA pertaining to registration and pricing may be contested to an “Objections Committee” within the JFDA. In general, an objection may be filed within 30 days of the date on which it is notified and the Committee must decide upon it within one month form the date of filing the objection. As for administrative decisions, any such decisions may be appealed to the Administrative Court and then to the Higher Administrative Court.
As for food products, though they fall within the competence of the JFDA, they are subject to a different legislation, the “Food Law No 30 of 2015” and challenges to the decisions taken by the JFDA with regard to all food products are governed by the Directives on Examining Objections to Food Control Procedures for the year 2017.
Other than narcotics and psychotropic substances, which are designated as medicines that can only be dispensed with a medical prescription, by virtue of the Narcotics and Psychotropic Substances Law, no other pharmaceuticals are classified as prescription-only by virtue of legislation. As a matter of practice, the JFDA determines the classification of products as prescription or non-prescription drugs at registration. In its determination, the JFDA relies on the indications and concentration of the product. In addition, the JFDA periodically issues a list of “over-the-counter medications” which is posted on its website and which is updated regularly.
Clinical trials conducted in Jordan are subject to Law No 2 of 2011 on Clinical Studies. The Law regulates drug-related therapeutic and non-therapeutic clinical studies, but does not cover medical devices. While therapeutic studies are defined by this law as “any clinical study performed on sick or healthy volunteers”, non-therapeutic clinical studies are described as “studies performed on healthy volunteers in terms of effectiveness, kinetics, bio-availability and bio-equivalence of a drug”.
Clinical trials of medical devices, however, are not regulated.
Only licensed entities are permitted to conduct clinical trials in Jordan. The licence is obtained from the Minister of Health upon a recommendation from the Clinical studies Committee at the JFDA. Entities that may be granted a licence to conduct clinical studies are the following:
Each licensed entity must have an Institutional Review Board (IRB) that makes a recommendation to the Clinical Studies Committee at the JFDA each time a permission for conducting a clinical study is requested. The clinical study submission form must be accompanied with an IRB-approved study protocol that provides the scientific justifications for the study, as well as any other requirements determined by the JFDA. In addition, the applicant must submit a signed insurance contract with a local insurer to cover the damages resulting from the trial.
The website of the JFDA contains a database that is available to the public and searchable by entering the title of the study, protocol number, purpose of the study or the condition that it addresses. The database provides key information about the trial, including the centre or hospital where the trial is conducted, the name of investigator(s), sponsorship details, contact persons for inquiries, study type (observational or interventional), recruitment status, primary and secondary outcome and the decision of the Clinical Studies Department at the JFDA approving or rejecting the trial.
Nothing in the Clinical Studies Law restricts the use of online tools in clinical trials. Such tools must, however, comply with the requirements of the Clinical Studies Law regarding voluntary informed consent for the participants and adherence to the Declaration of Helsinki, as well as any other relevant requirement in any applicable legislation.
Jordan does not yet have a specific data protection legislation, though a draft “Personal Data Protection Law” is under review and has yet to obtain the necessary parliamentary approval. Currently, the Clinical Studies Law only provides for the requirement to comply with good clinical practice, pursuant to directives that are to be issued by the Minister of Health, but which have not been issued to date. As a matter of practice, however, the Clinical Studies Department at the JFDA strictly observes the EU GDPR (General Data Protection Regulation) in all that relates to clinical research.
As a matter of practice, the JFDA ensures that all databases created by research centres comply with good clinical practice.
The Guidelines on Trading in Medical Supplies including Antiseptics and Disinfectants for the year 2019, which are issued under the Drug and Pharmacy Law, consider medical devices as part of Medical Supplies, which are defined as being:
All devices, means, substances, tools, items or reagents and calibrators, including the software required for their operation, whether used alone or in association with another, that are intended by the manufacturer for human use for achieving any of the following purposes:
According to this definition, what differentiates medical supplies, including medical devices, from drugs is that “they do not achieve their intended action in/on the human body by pharmacological, immunological or metabolic means but may be assisted in their function by such means”. It is to be noted in this regard that the definition of “drugs” under the law comprises all pharmaceuticals that are defined as being:
The Drug Registration Guidelines for the year 2015 include biological medicinal products within their scope.
Marketing authorisations/registrations are valid for five years from the date of registration or renewal of registration of a pharmaceutical, including biological medicinal products, while the period of validity for the registration of medical devices is ten years.
The application for renewal must be submitted to the Drugs Directorate at the JFDA within three months of the expiry of its registration or last renewal; otherwise, the registration is cancelled.
If the registration is being renewed for the first time, the application must be accompanied by a number of documents that are listed in an annex to the guidelines. For subsequent renewals, only the free-sale certificate from the country of origin and a price certificate are required.
A justified decision approving or refusing the renewal, or determining a new price for the product, is notified to the applicant and the applicant may object to the decision within 30 days of the date of that notification.
The JFDA may prohibit the import of a product, cease its sale or distribution, ban its marketing, suspend or revoke its registration or recall it, if:
The application for registration must be submitted by the pharmacist in charge at the drugstore/local manufacturing plant, together with a dossier containing all the required documents, which will vary depending on whether the product in question is new, generic, patented, manufactured under licence, or pursuant to a contract or technology transfer. The applicant must also provide pricing certificates, stability studies and bio-equivalence studies for generic products.
An application accompanied with a complete dossier is assessed against the following criteria: efficacy, safety and quality of the product. In order to be registered, however, a product must be registered and actually be marketed with the same composition for at least one year in the country of origin.
Otherwise, a free-sale certificate from an accredited country must be provided, together with a statement regarding the reasons the product is not placed on the market in its country of origin.
The decision must be issued within 180 days from the date on which the completed dossier is filed by the applicant, or 180 days prior to the date of expiry of the patent for patented drugs. The registration is notified by the JFDA to all relevant entities, such as the Pharmacists Association, the Medical Association, and the Association of Drug Manufacturers. In addition to this, all drugs that are registered, or for which an application for registration has been filed, are to be posted on the website of the JFDA.
Variations to registered products must be reported to the Drugs Directorate at the JFDA, which examines the application pursuant to the Directives on Variations to Registered Drugs for the year 2017. These Directives contain an exhaustive list of variations that fall within their scope, which includes: specific changes in sterile and non-sterile products, variations that are common to all pharmaceutical forms (such as shelf life, storage conditions, trade name, etc), and variations to biological products. These variations are classified into: variations that require the approval of the Technical Committee, which are reviewed within 90 days of the date of the application; variations that require the approval of the Registration Department, which are reviewed within 30 days of submission; and variations that require notification of the Drugs Directorate, which are provided with immediate approval. Any changes that are not listed in the Directives are assessed by the relevant department at the JFDA and classified accordingly. It is to be noted in this regard that there are certain cases that are not treated as variations, but rather require the submission of a new application for registration. These include new pharmaceutical forms or concentrations of the product and changes in the active ingredient.
Marketing authorisation can be transferred from one holder to another. The marketing authorisation-holder (MAH) is defined in the guidelines as being “the company responsible for the safety, quality and efficiency of a product, ensuring that it is manufactured in accordance with the good manufacturing practice for pharmaceutical manufacturing, approving the batch release to the market and following up post-marketing, sale, withdrawal and disposal procedures”. In accordance with the guidelines, the MAH must be a manufacturing company that is accredited by the JFDA or an office that owns, or is owned by, an accredited manufacturer. The guidelines also require that the following entities be considered as marketing authorisation-holders:
In the practice of the JFDA, the marketing authorisation-holder will continue to be as specified on the free-sale certificate (or as the case may be subject to the above guidelines) unless the JFDA is furnished with a document that proves otherwise; ie, an agreement under which the marketing authorisation rights are granted by the original holder to another entity.
With regard to medical devices, the Guidelines on Trading in Medical Supplies do not require marketing authorisation-holders to be a drugstore or manufacturer. The guidelines require the registration of certain medical devices and set out conditions for their import according to a risk-level-based classification. This classification relies on the following EU directives: Medical Devices Directive 93/42/EEC; Active Implantable Medical Devices Directive 90/385/ EEC; and In-Vitro Diagnostic Directive 98/79/EEC.
While some medical devices, such as products falling under Classes I and IIa (which comprise most non-invasive devices), do not require registration under the Principles, any products that are deemed as medical devices need to be approved for import by the JFDA and must comply with certain conditions listed in an annex attached to the Principles. These conditions mainly pertain to the documents required for import purposes as well as the information that must be included on labels and inner and outer packaging.
The transfer of the marketing authorisation of a medical device from one entity to another is considered to be a variation that requires notification in writing to the JFDA in addition to obtaining the approval of the Medical Supplies Committee.
Unregistered pharmaceuticals may be imported into Jordan in non-commercial quantities for specific patients, pursuant to an application in which the patient undertakes that the product is for his or her personal use. The application must be accompanied with a medical report and a prescription indicating the daily dosage and period of use. For chronic diseases, the JFDA grants approval for a quantity not exceeding a three-month supply, while for acute diseases the approval is for the quantity specified by the physician.
Medical devices can also be approved for import without registration by virtue of a decision from the JFDA if they are donated to governmental entities or societies registered with the Ministry of Social Development or if they are for the use of specifically named patients, pursuant to a medical report.
The Directives on Principles of Pharmacovigilance for the Year 2016 require all marketing authorisation-holders to report to the JFDA any side-effects of pharmaceuticals and any issues pertaining to their use (including lack of efficacy, manufacturing defects, contamination, medication errors, overdose, abuse and misuse of the product) as well as any recall of a product that is already being marketed in Jordan. Spontaneous reports must be made within specified periods of time, depending on the seriousness of the side-effect in question. Authorisation-holders must also report any measures taken by the authorities in the reference state or by the holder itself as a result of unexpected adverse drug reaction, any suspicion of an increase in the rate of occurrence of an expected adverse effect, any issues with the efficacy of a products used in the treatment of a life-threatening disease and, generally, any other drug-related issues that may result in serious health risks. In addition, the designated qualified person within the authorisation-holder entity must furnish the JFDA with the following reports:
Marketing authority-holders for medical devices, however, are only subject to the obligation to provide spontaneous reports regarding any deaths, injuries or adverse effects or issues that have an impact on the safety of patients.
All drugs that are registered, or for which an application for registration has been filed, are posted on the website of the JFDA and are accessible to the public. Third parties can therefore only learn if a drug is registered or if it is pending registration. Decisions refusing registration, or the causes of any such refusal, are not accessible to the public.
Currently, Jordan does not have a specific data protection legislation, although a draft “Personal Data Protection Law” is under review and is pending the necessary parliamentary approval. However, the Unfair Competition and Trade Secrets Law No 15 of 2000 expressly provides that, in cases where an official authority requires, for the purposes of approving the marketing of a pharmaceutical product, the submission of data that pertains to secret tests or that was procured as a result of considerable efforts (on the part of the holder of the trade secret), that entity is under an obligation to protect such data from unfair commercial use by preventing any other person from relying on that data to market similar products, except after the lapse of five years from the date on which the party that had submitted the data obtained the approval for marketing its products. The authority concerned, which is the JFDA in this case, must also protect the data from disclosure, except if such a disclosure is deemed necessary for the protection of the public and if the entity has taken all necessary measures to ensure the protection of the data from unfair commercial use.
Falsified and illegally distributed medicines may be subject to measures taken by the JFDA that include banning their import, sale, distribution or marketing, suspending or revoking their registration or recalling them from the market.
In addition to that, the sale or distribution of falsified medicines may result in a penalty of imprisonment for a period ranging between three to five years and/or a fine of JOD1,000 to JOD5,000 (approximately USD1,400 to USD7,000) as well as an additional fine in an amount equivalent to ten times the sale price of the false products.
Interested parties may also claim compensation by filing a civil lawsuit under the Unfair Competition and Trade Secrets Law.
If committed by a pharmacist, illegal distribution of medications and medical devices is penalised with a fine of JOD1,000 to JOD5,000 (approximately USD1,400 to USD7,000) in addition to disciplinary measures by the Pharmacists Association. If such an act is committed by a non-pharmacist, it may also result in imprisonment for one to six months.
Furthermore, the JFDA is authorised to confiscate any products that violate the law and to close down temporarily any establishments that trade in such products.
All goods that are subject to confiscation under the Goods Marks Law No 19 of 1953, including counterfeit pharmaceuticals and medical devices, may not be imported into Jordan and may be blocked from entry through the borders by filing an application to the court and informing the Customs Department to suspend their entry pending the issuance of the final decision by the court.
Pharmaceutical manufacturing plants are subject to a licence issued by the JFDA upon the approval of the Minister of Health. The application for the licence must be submitted to the JFDA with the required information and supporting documents. A specialised committee at the JFDA inspects the site of the plant, after which a recommendation is made to the Minister of Health to approve the issuance of the licence. The activities that may be carried out by licensed plants are the composition, preparation and portioning of drugs and the manufacture of raw materials on an industrial scale for wholesale purposes. A manufacturing plant licence, however, cannot be granted if the purpose of the plant is restricted to packaging and portioning activities. A licence that is issued to a manufacturing plant does not have a validity period, but it is considered to be automatically revoked if the plant is not established within three years of the date on which it procures the construction permit, unless it approves granting the applicant an extension for an additional three-year period upon a justified request.
The Minister may also decide to revoke the licence in the following circumstances:
Plants that are engaged in the manufacture of medical devices are not specifically regulated.
Establishments that are engaged in the wholesale of pharmaceuticals and medical devices are called “drugstores” and require a licence from the Minister of Health upon a recommendation from the Pharmacists Association. The application for the licence must be submitted to the Ministry of Health with the required information and supporting documents. A specialised committee at the Minister inspects the site of the drugstore, after which a recommendation is made to the Minister of Health to approve the issuance of the licence. The licence permits a drugstore to import, purchase, sell, store and distribute pharmaceuticals and medical devices to pharmacies and any other entity that is authorised to sell such products. A licence that is issued to a drugstore does not have a validity period, but it is may be revoked pursuant to a decision by the Minister of Health if the drugstore does not commence its operations within one year of the date of issuance of the licence. The Minister may also decide to revoke the licence of a drugstore in the same cases in which he or she may revoke the licence of a manufacturing plant.
See 1.3 Different Categories of Pharmaceuticals and Medical Devices.
The import and export of pharmaceuticals is subject to the Drug and Pharmacy Law and the regulations and directives issued pursuant to it. The governmental entities concerned with the application and enforcement of these legal provisions are the JFDA and the Customs Department.
In order to import pharmaceuticals, the importing establishment must be licensed as a drugstore and must be the establishment that acts as the agent of the pharmaceutical company. In addition, the products must be imported from the manufacturing site that is accredited by the JFDA. The Minister of Health, however, may allow the import of drugs by any other entity for reasons of pharmaceutical security.
In the case of medical devices, the importer is neither required to be a drugstore nor an agent of the manufacturer. However, in the case of medical devices that are subject to registration, such devices can only be imported by the entity that registers them.
The import of all pharmaceuticals and medical devices requires the prior approval of the JFDA. In the case of narcotic drugs and psychotropic substances, an import licence from the Minister of Health is required.
The Imports Directives for the Year 2015 include annexes which list the products requiring an automatic import licence that is automatically issued upon meeting certain conditions or a non-automatic licence that is subject to the discretionary approval of certain authorities. These annexes also indicate the entity that is authorised to issue such licences. The products referenced in the annexes are listed on the basis of their technical description.
Jordan is a member of the World Trade Organization (WTO) and the Greater Arab Free Trade Agreement (GAFTA). It also has bilateral trade agreements with Canada, the European Free Trade Association (EFTA), the EU, Singapore, and the US.
The Drugs and Pharmacy Law treats the sale of drugs as a regulated activity and considers the prices that are determined by the JFDA for such drugs as binding. A pricing committee within the JFDA determines the price of drugs in accordance with certain formulae that are regularly updated by the JFDA. This price, which is inclusive of the profits and administrative expenses, is considered to be binding on the drugstore that distributes the drug.
The law does not place any limits on the profit made by distributors in relation to medical devices and these devices are not priced by the JFDA as in the case of drugs.
In determining the prices of drugs in Jordan, the JFDA chooses the least of: the price in the country of origin; the median price in 16 reference states; and the price of the product in the Saudi market.
Jordan does not have a national health insurance scheme. Therefore, the only instances where the cost of medicines or medical devices may be reimbursed from public funds is in the context of insurance provided to public servants and members of the armed forces.
As previously mentioned, Jordan follows reference pricing of pharmaceuticals that takes only the elements referred to in 7.1 Price Control for Pharmaceuticals and Medical Devices and 7.2 Price Levels of Pharmaceutical or Medical Devices into consideration.
Considering that there is no national health scheme that covers Jordanian citizens, the only clear examples of control of pharmaceutical spending can be found in the scrutiny exercised by private insurance companies and third-party administrators.
There are currently no specific rules in place for medical apps in Jordan. Based on the definition of “medical devices” under the current laws and regulations, medical apps are not considered medical devices.
There are currently no specific and separate rules for telemedicine in Jordan. The Medical and Health Accountability Law No 25 of 2018 regulates and governs the provision of medical and healthcare services by physicians within Jordan. This law prohibits physicians from prescribing medicines to patients prior to conducting the necessary examinations. Also of relevance is the Medical Constitution, Doctor’s Obligations and Professional Conduct Regulation of 1989, which prohibits doctors from issuing any medical reports prior to conducting a medical examination of the relevant patient. In the absence of any express provisions under Jordanian legislation prohibiting physicians from providing medical attention through a mobile device or allowing them to do so, the aforementioned provisions can be construed to imply that physicians must perform proper physical examinations of patients prior to providing any medical consultations and/or prescribing medicines.
The Drugs and Pharmacy Law prohibits the advertising and/or promotion of any medicines or any substance that is described as having a medicinal characteristic through any media means, whether print, audio, visual or any other means, except after obtaining the approvals of the Minister of Health and the Jordan Pharmacists Association. Additionally, the Directives on the Regulation of the Promotion of Medicines of 2016 govern the promotion of medicines to healthcare service-providers and includes guidelines and restrictions on the promotion methods and the contents of promotional material.
Electronic prescriptions are regulated and allowed in Jordan. Pursuant to the Private Hospitals Regulation No 54 of 2014 (the Private Hospitals Regulation), private hospitals are permitted to utilise electronic prescriptions instead of paper prescriptions. Additionally, the Directives on the Use of Electronic Files and Prescriptions at Public Hospitals and Healthcare Clinics of 2013 (the Electronic Files and Prescriptions Directives) allow public hospitals and healthcare clinics to utilise electronic programs, subject to the approval of the Minister of Health, for the purposes of creating electronic records and issuing electronic prescriptions.
There are no laws or regulations which expressly prohibit the online sales of medicines and medical devices in Jordan. However, the practice of the JFDA is to prohibit such activities, based on the legal provisions prohibiting promotion and advertising of any medicines or any substance that is described as having a medicinal characteristic, as detailed in 8.3 Promoting and/or Advertising on an Online Platform.
The Private Hospitals Regulation and the Electronic Files and Prescriptions Directives allow both private and public hospitals and clinics to keep electronic health records of patients. Health-related information is currently not regulated in Jordan; however, under the draft law on the protection of personal data which has yet to obtain the necessary parliamentary approval, personal information relating to an individual’s medical, physical or mental condition is captured under the definition of “sensitive data”. Pursuant to the draft law, such sensitive data may not be processed without the approval of the individual to whom the data pertains, subject to some exceptions. There is currently no legislation relating to the use of cloud platforms for the storage of health records.
Patents in Jordan are governed by the Patents Law No 32 of 1999 (as amended) (the Patents Law). In this regard, it is worth noting that Jordan is a signatory to the Patent Co-operation Treaty, and that the Patent Law was last amended pursuant to the Amended Patent Law No 17 of 2017 to conform to this treaty.
There are no patentability requirements that are specific to pharmaceuticals or medical devices under the Patents Law; however, the Patents Law provides that patents of invention for manufacturing and chemical processes relating to chemical products and pharmaceuticals may be granted. Additionally, this law also permits the filing of patent applications for registering inventions involving the protection of final products for chemical products relating to pharmaceuticals or medicines.
It is also worth noting that the Patents Law allows the Minister of Industry and Trade to grant an applicant for a patent registration the exclusive right to market the chemical products relating to medicines or pharmaceuticals covered by the patent subject for five years or until the date of patent grant or rejection, whichever is shorter, subject to certain conditions.
There are no specific provisions under the Patents Law relating to second and subsequent medical uses of a known product. As a general rule, any product is regarded as patentable if it satisfies the criteria provided for under the Patents Law.
Patents in Jordan are granted for terms of 20 years and may not be extended beyond that 20-year term.
Under the Patents Law, and when the subject-matter of the patent is a product, the manufacturing, utilisation, use, promotion, sale and importation of the patented product without the approval of the patent-holder constitutes an infringement of the patent. In the case of manufacturing process patents, the use of such a process, or the use, promotion, sale or importation of the product that is manufactured directly through such a process, constitutes infringements of the patent.
The threat of infringement is actionable under Jordanian law. A patent-holder may request that the court order certain precautionary measures, as detailed in 9.6 Proceedings for Patent Infringement, prior to filing the civil or criminal lawsuit and without notifying the defendant, if the patent-holder proves that he or she is the holder of the relevant patent, that his or her patent is being infringed upon or any such infringement is imminent, and that he or she is likely to sustain irreparable damage or the related evidence may be hidden or destroyed.
The Patents Law provides that scientific research and development and the filing of applications for obtaining marketing permits before the lapse of the patent protection period shall not be regarded as either a civil or a criminal infringement.
Moreover, the Patents Law provides that the Minister of Industry and Trade may grant a licence to use a patent to third parties without obtaining the consent of the holder of the patent in any of the following cases exclusively:
The holder of a registered patent can bring proceedings for patent infringement. Pursuant to the Patents Law, the following precautionary measures may be requested from the court while criminal or civil proceedings are under process or under review:
The patent-holder may request that the court take any of the measures listed above before filing the civil or criminal lawsuit without notifying the defendant if the patent-holder proves that he or she is the holder of the relevant patent, that his or her patent is being infringed upon or such an infringement is imminent, and that he or she is likely to sustain irreparable damage or the related evidence may be hidden or destroyed. The request of such a measure will require submission of a bank or monetary guarantee that is acceptable to the court. The defendant may appeal such a decision within eight days from the date on which the defendant is notified of the decision. If the patent-holder does not proceed with the lawsuit within eight days of the court’s decision, all the measures taken will be considered null.
The court may decide to stop the aforementioned precautionary measures, including the closing-down of the enterprise, factory, or others, upon an application by the defendant, also accompanied by a bank or monetary guarantee that is acceptable to the court. Such a decision shall be appealable within eight days, and the decision of the court of appeal is considered final.
A defendant of a patent-infringement action may claim for equitable compensation if it is proven that, as a result of the lawsuit, the plaintiff is not rightful in his or her claim or that the lawsuit was not filed within the prescribed period. The court may decide to seize the products, tools and materials which are mainly used for manufacturing the patented product and the court may decide to destroy or dispose of them for non-commercial purposes.
As for the available remedies for patent infringement, the Patents Law provides that whoever commits any of the following actions in bad faith shall be punished by imprisonment for no less than three months and no more than one year, or a fine of no less than 100 Jordanian Dinars and of no more than 3,000 Jordanian Dinars, or by both penalties:
The aforementioned penalties also apply to those who intend to commit any of the acts described or those who help in or encourage committing those acts.
Additionally, a patent-holder may claim damages for any damage or loss sustained due to any of the acts listed above.
There are no provisions under applicable laws and regulations relating to pre-launch declaratory actions clearing the way in advance of attempted market entry. The authorisation procedure for pharmaceuticals and medical devices with the JFDA does not take patent protection into account, nor does the JFDA communicate with other regulatory authorities upon the submission of a new authorisation application. The JFDA will only take such protection into account if a patent-holder notifies the JFDA of a potential infringement of its relevant patent.
The Drugs and Pharmacy Law provides that a medicine shall be considered counterfeit under any of the following cases:
The Drugs and Pharmacy Law prohibits the trade of any counterfeit medicine in Jordan, and subjects any person who commits such acts to penalties of imprisonment for three to five years, in addition to monetary penalties.
The Marks of Goods Law No 19 of 1953 includes provisions against the counterfeiting of products in general. Under this law, the forgery of trade marks, the illegal use of trade marks or other similar trade marks in a misleading manner and the use of a false product description are punishable by imprisonment of no more than one year, or a fine of no more than 100 Jordanian Dinars, or by both punishments, unless the committer of those actions proves that he or she has committed such acts in good faith.
Moreover, the sale of goods or things carrying a forged trade mark or false product description, or offering them for sale, or possessing them for sale or for any commercial or industrial purposes, or the illegal use of a trade mark or other similar trade marks in a misleading manner, are also punishable by the aforementioned punishments, unless the committer of such an action proves:
Trade marks in Jordan are governed by the Trade Marks Law No 33 of 1952. Pursuant to this law, a trade mark is eligible for registration if it is distinctive in terms of words, letters, numbers, figures, colours, or other signs or any combination thereof that is visually perceptible. These criteria apply to all trade marks and not only those that can be used for pharmaceuticals and medical devices.
The following marks are not eligible for registration under the Trade Marks Law:
The above-listed restrictions are applicable to all trade marks and not specifically those to be used for pharmaceuticals and medical devices.
IP protection is available in Jordan for the trade dress or design of products in general, pursuant to the Industrial Designs and Models Law No 14 of 2000. This law defines “Industrial Designs” as any composition or arrangement of lines, which gives the product a special appearance or appeal, whether made using machines or by hand, including textile designs. “Industrial Models” are defined under the law as any three-dimensional form, whether associated with lines or colours, or not, which gives a special appearance, whether made by machines or by hand.
Pursuant to this law, an industrial design or model may be registered if the following conditions are met:
After the registration of an industrial design or model, the owner shall have the right to prevent third parties from manufacturing, importing or selling products bearing the registered design or embodying the registered model which is a copy, or substantially a copy, of the registered design or model. Such protection does not extend to any part of a registered industrial design of model if that part was dictated by pure technical or functional considerations. The term of protection of an industrial design or model is 15 years, commencing on the date of filing the application of registration.
Data exclusivity has been implemented in Jordan since joining the World Trade Organization and signing a Free Trade Agreement with the United States in 2001. Moreover, national IP legislation has been modified to implement the provisions of the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS), and the Unfair Competition and Trade Secrets Law No 15 of 2000 was adopted in Jordan. Pursuant to the Unfair Competition and Trade Secrets Law, and in compliance with TRIPS, drug regulatory authorities do not allow the registered data of an innovator to be used as a reference for application for a therapeutically equivalent generic version of that medicine for a period of five years. There is no distinction under this law between chemical drugs and biologics.
While there were no special regulations or guidelines issued in relation to the commercialisation or distribution of medicines and medical devices aimed at handling COVID-19 in Jordan, the Drug Registration Guidelines for the year 2015 provides a list of drugs (including vaccines) which are granted priority in consideration of their registration applications by the JFDA. This list includes drugs that contain a “New Chemical Entity (NCE)”, biological drugs, serums and vaccines which have obtained “certificates of free sale” from the United States Food and Drug Administration and the European Medicines Agency, provided that an “Assessment/Review Report” of the drug from health authorities is submitted along with the registration application. Additionally, these guidelines entitle the General Manager of the JFDA to grant exceptions from certain drug-registration requirements with regard to drugs used to treat epidemic and endemic diseases and drugs with therapeutic advantage, where the purpose of such exceptions is achieving drug security. These exceptions were granted in relation to COVID-19 vaccines that were granted priority by the JFDA.
It is also worth noting that, in response to the COVID-19 crisis, a royal decree was issued that activated as of 17 March 2020, the “Defence Law”, which is a law that grants the Prime Minister extraordinary powers during a state of emergency, such as in the case of a pandemic. This law entitles the Prime Minister to exercise such powers by virtue of “Defence Orders” that have the effect of suspending the operation of ordinary laws of the State.
While there were no special measures issued in relation to ongoing clinical trials, the JFDA issued a circular in March of 2020 addressed to all clinical trial research centres and hospitals, which included certain precautionary measures that must be taken by all such centres and hospitals to limit the spread of the virus.
Regulatory pathways applicable for emergency approvals of pharmaceuticals are already in place, as they are provided for under the Drug Registration Guidelines for the year 2015. See 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices.
Due to COVID-19 and the difficulty in performing routine inspections of drug manufacturing plants for the purposes of renewal of Good Manufacturing Practice (GMP) certifications of such plants, the JFDA issued a circular in October 2020, pursuant to which local drug manufacturing plants were informed that any GMP certificates expiring in the year 2020 will be considered as extended for a period of one year from the date of expiry.
The JFDA issued a circular in March 2020, pursuant to which drugstores were informed that they may send all import invoices through the electronic Import/Export System (IES) of the JFDA, whereby the entire application will be handled electronically (including the payment of associated fees) and referred to the JFDA’s representative at the Customs Department, without the need for physically visiting the JFDA.
Additionally, the JFDA issued a circular in December 2020 informing drugstores and drug companies that, following the circular issued by the European Medicines Agency dated 30 March 2020 in relation to the issuance of electronic free-sale certificates instead of physical certificates due to the current circumstances, the JFDA will accept such electronic certificates under registration files and other applications, provided that a letter of undertaking is submitted along with those certificates. By virtue of such a letter, the relevant party would undertake to legalise the certificate by the Jordanian Embassy and Ministry of Foreign Affairs at a later stage.
No measures were adopted in Jordan to facilitate digital healthcare innovation or digital transformation, due to COVID-19.
The government of Jordan did not announce any intention to issue compulsory licences for COVID-19 related treatments or vaccines. See 9.5 Defences to Patent Infringement in Relation to Pharmaceuticals and Medical Devices for applicable rules.
No liability exemptions have been introduced in existing or new provisions regarding COVID-19 vaccines or treatments.
No existing provisions have been used or new ones introduced to allow the requisition or conversion of manufacturing sites due to COVID-19.
No changes have been made to the system of public procurement of medicines and medical devices as a result of COVID-19.