Chambers Life Sciences 2017 – Mauritius
Law & Practice
Contributed by Juristconsult Chambers

1.1 Key Legislation

The key pieces of legislation governing the authorisation, marketing, sale and supply of pharmaceutical products in Mauritius are the Pharmacy Act 1983 and the Consumer Protection (Price and Supplies Control) Act of 1998.

The term “Pharmaceutical Product” is defined as a drug, medicine, preparation, poison or therapeutic substance.

“Drug” is defined as a substance or ingredient intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in a human being or an animal.

“Medicine” is defined as a chemical product, preparation, biological product or other substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of any ailment, infirmity or injury affecting a human being or an animal or for dental treatment.
“Poison”:
(a) means a substance specified in the First, Third, Fourth and Fifth Schedules of the Pharmacy Act 1983;
(b) subject to paragraph (c), includes any poisonous substance or liquid;
(c) does not include:

  • a substance which is an ingredient in adhesives, anti-fouling compositions, builders’ materials, ceramics, distempers, electrical valves, enamels, explosives, fillers, fireworks, fluorescent lamps, glazes, glue, inks, lacquer solvents, loading materials, machine spread plasters, matches, motor fuels and lubricants, paints other than pharmaceutical paints, photographic paper, pigments, plastics, propellants, rubber, surgical dressings, varnishes or vascular plants and their seeds;
  • a substance specified in the first column of the Second Schedule and constituted or used in the manner specified in the second column of that Schedule;
  • any article containing barium carbonate or zinc phosphide which has been prepared for the destruction of rats or mice;
  • cannabis or a cannabis derivative when used as an ingredient in a corn paint.
    “Preparation” means:
  • a solution or mixture, in any physical state, containing a medicine or a therapeutic substance; or
  • a medicine or a therapeutic substance in dosage form.

 

“Therapeutic substance”:

 

  • means a substance whose purity and potency cannot be adequately tested by chemical means; and
  • includes a preparation.

 

Pharmaceutical products are divided into prescription pharmaceutical products, non-prescription pharmaceutical products and simple medicines.

1.2 Regulatory Bodies

The Pharmacy Board is responsible for the regulation of pharmaceutical products whereas the Minister of Industry, Commerce and Consumer Protection is responsible in terms of pricing.

1.3 Regulations

Medical devices and cosmetics are not regulated under Mauritius laws.
Nutritional products are regulated by the Foods Act 1998 and the Food Regulations 1999 (the “Regulations”).
“Food” is defined in the Food Act 1998 as any article or substance meant for human consumption and includes:

  • drinks and bottled water;
  • chewing gum and other products of similar nature and use; and
  • articles and substances used or intended for use as ingredients in the composition or preparation of food, but does not include:
  • live animals, birds or live fish which are not used for human consumption while they are alive;
  • fodder or feeding stuffs for animals, birds or fish;
  • drugs or medicine as defined in the Pharmacy Act; and
  • hormonal products or veterinary products for use in livestock feed.

No person shall import or manufacture any food, pre-packed food, container or contact material intended to be used for the preparation of any food listed in the third schedule to the Regulations (set out below) unless he has obtained a pre-market approval permit issued by the Permanent Secretary of the Ministry of Health and Quality of Life (the “Permanent Secretary”).

LIST OF FOOD, PREPACKED FOOD, CONTAINER AND CONTACT MATERIAL REQUIRING PRE-MARKET APPROVAL

  • any novel food (being any food which has not previously been used for human consumption in Mauritius)
  • artificial sweetener
  • baby feed bottle, teat, nipple and baby feed mug
  • biscuit
  • breakfast cereal
  • canned food for infant and child, infant formula, icing sugar
  • cereal based food for infant and child
  • coffee and chicory blend, cocoa, jam
  • confectionery, snack and cracker, water, chocolate, pastry
  • dry egg powder, liquid egg including egg yolk and egg white
  • edible fat and oil, including shortening, margarine, vanaspati, ghee
  • essence
  • fish product
  • food additive
  • food conditioner
  • food container and contact material
  • formula dietary food
  • frozen confection and related product
  • fruit juice, fruit cordial, soft drink, soft drink powder
  • honey
  • irradiated food
  • low energy food
  • meat product
  • milk and milk product including ice cream, condensed milk, evaporated milk, sterilised milk, UHT milk, tinned cream, cheese, butter
  • mixed spice, pickle, preserved vegetable, preserved egg
  • non-alcoholic beverage
  • nutrient supplement
  • oriental saffron (Jaffran)
  • poultry product
  • refined salt, table salt, iodised salt, low sodium salt, salt for salting fish
  • roasted cereal, nut
  • sauce, vinegar, relish, including salad dressing and mayonnaise, seasoning
  • self-raising flour, baking ingredient
  • special purpose food
  • tomato paste, ketchup, bottled water

A person who applies for a pre-market approval permit must furnish to the Permanent Secretary:

  • an original certificate of analysis from an accredited laboratory from the country exporting the product, certifying the chemical composition and microbiological safety of the product; and
  • such other document or information, or such sample for analysis or examination, as the Permanent Secretary thinks fit.

The Permanent Secretary may, in deciding whether to grant or refuse an application for a pre-market approval permit, consider among other factors whether the food, pre-packed food, appliance, container or contact material subject matter of the application is:

  • violating any regulation made under the Food Act 1998;
  • restricted for sale in Mauritius;
  • misbranded;
  • improperly labelled; or
  • likely to be hazardous to public health.

The Permanent Secretary may stipulate such conditions as he deems fit in a pre-market approval permit.

In borderline cases and in any event, the Permanent Secretary has the sole discretion to determine whether the pre-market approval will be granted.

The law does not provide any appeal procedure where the initial decisions are unfavourable.

2.1 Regulation of Clinical Trials

Clinical trials are regulated in Mauritius by the Clinical Trials Act 2011 and the Clinical Trials (Licence and Fees) Regulations 2011.

2.2 Approval and Authorisation

No person may conduct or cause or permit to be conducted a clinical trial unless that person is the holder of a trial licence (“TL”) or an investigator acting on behalf of a sponsor who is the holder of a TL, in relation to that clinical trial. “Investigator” means a medical practitioner, or other health professional acceptable to the CRRC, who is designated by a sponsor to be responsible for the conduct of a clinical trial. “Sponsor” means a person who assumes responsibility for the initiation, management and financing of a clinical trial.

The Clinical Research Regulatory Council (“CRRC”) is responsible for the regulation and control of trial licences being issued. An application for a TL should be made in writing to the “CRRC accompanied by 25 copies of the following documents together with the application fee of MUR10,000 (approx. USD300):

  • a protocol (being a document which describes the objective, design, methodology, statistical consideration and organisation of a clinical trial);
  • an investigator’s brochure (being a compilation of the clinical and non-clinical data on an investigational medicinal product which are relevant to the study of the product in a subject);
  • a brief CV of every investigator;
  • a Certificate of Good Manufacturing Practice and a Certificate of Pharmaceutical Product in relation to every investigational medicinal product from its country of origin; and
  • the separate and different forms to be used for the purposed of patient and subject information, informed consent, recruitment of subjects, adverse event reports and adverse reaction reports.

The sponsor must also provide the following:

  • information as to the quantity of every investigational medicinal product to be used in the clinical trial;
  • information relating to the measures to be taken for the health, welfare, safety and protection of subjects;
  • information relating to financial aspects of the clinical trial, in particular:

a) sources of funding for the clinical trial and information on the financial or other interests of the sponsor relevant to the clinical trial;
b) the arrangements for the reimbursement of expenses incurred by the subjects;
c) any provision for compensation in the event of injury or death resulting from the clinical trial, including details of any insurance cover to be contracted for the protection of subjects;
d) details of any insurance or indemnity to cover the liability of the sponsor and investigator;
e) summary details of any financial arrangements between:
i) the sponsor and the investigator; and
ii) the sponsor and the owner or occupier of the site;

  • information relating to the anticipated benefits and risks of the clinical trial;
  • information relating to the location, structure and amenities of any site where the clinical trial is to be conducted; and
  • such other information as the CRRC may require.

Where the CRRC receives a complete application, it refers the application with all supporting documents to the Ethics Committee (which advises the CRRC regarding welfare, safety, health and protection of human subjects participating in clinical trials), which gives its opinion.

The Ethics Committee takes such factors at it thinks fit into consideration, including:

  • the relevance of the clinical trial and its protocol;
  • the suitability of any investigator;
  • the anticipated benefits and risks of the clinical trial;
  • the adequacy of the measures to be taken for the health, welfare, safety and protection of subjects; and
  • the adequacy of the insurance cover to be contracted for the protection of subjects.

It is to be noted that the Ethics Committee is responsible for establishing and following its own standard operating procedures.

The CRRC may then after considering the opinion of the Ethics Committee grant an application where it is satisfied that:

  • the measures to be taken for the health, welfare, safety and protection of subjects are adequate;
  • the anticipated benefits of the clinical trial outweigh its risks;
  • the insurance cover to be contracted for the protection of subjects is adequate;
  • the investigator is a suitably qualified person;
  • the site for the clinical trial is suitable;
  • the sponsor and the investigator will at all times comply with the Clinical Trials Act 2011 and any regulations made under it; and
  • the clinical trial is to be conducted in compliance with any guidelines issued by the CRRC.

The CRRC may, when considering an application, require the sponsor to furnish such additional information as may be necessary, within such time as it may determine.

On granting an application, the CRRC will issue a trial licence to the sponsor on such terms and conditions as the CRRC thinks fit and on payment of the applicable prescribed licence fee.

2.3 Registration and Publication of Results

It is mandatory to register new clinical trials in a publicly available database and to publish the results of all clinical trials.

3.1 Process for Obtaining Marketing Authorisation

Our laws do not make any specific provisions relating to marketing. The only provisions existing in our laws relate to advertising as follows:

“No person shall advertise any pharmaceutical product intended for human or veterinary use except in such technical or professional publications, as may be approved by the Board.” (Section 41 of the Pharmacy Act 1983)
Reference to the “Board” here is reference to the Pharmacy Board.

3.2 Third-Party Data

3.3 Validity of Marketing Authorisation

3.4 Paediatric Population

There is no mandatory requirement to conduct clinical trials in the paediatric population under our laws.

3.5 Varying a Granted Authorisation

3.6 Transferring Authorisations from One Party to Another

3.7 Access to Unauthorised Products

3.8 On-going Obligations

3.9 Post-marketing Obligations

Please refer to 3.1 Process for Obtaining Marketing Authorisation.

Furthermore, the only requirement for pharmacovigilance is for clinical trials in general whereby a sponsor has the duty to keep detailed records of any adverse event, serious adverse event, adverse reaction or serious adverse reaction, which:

  • arises during a clinical trial;
  • comes to his knowledge from reports of similar clinical trials conducted elsewhere; or
  • is reported to him by the investigator.

The sponsor must submit the records referred to above to the CRRC and the Pharmacovigilance Committee on each anniversary of the clinical trial or upon request by the CRRC or the Pharmacovigilance Committee, as the case may be.

Furthermore, an investigator must, within 24 hours of becoming aware of a serious adverse event or serious adverse reaction, inform the sponsor of the event or reaction.

When the sponsor receives information form the investigator, it must, within 24 hours, notify the CRRC and the

Pharmacovigilance Committee in writing of the serious adverse event or serious adverse reaction.
A sponsor must provide such follow-up information relating to the serious adverse event or serious adverse reaction as the CRRC or Pharmacovigilance Committee may require.

3.10 Third Party Access to Pending Application

3.11 Third Party Access to Additional Information

4.1 Setting and Controlling Prices

Pursuant to regulation 9(1) of the Consumer Protection (Consumer Goods) Maximum Mark-Up Regulations 1998, every importer shall, prior to making a sale or supply of a medicine, affix a label to every pack, packet or container of the medicine, indicating legibly his name and the maximum retail price at which the medicine is to be dispensed, exposed, offered for sale or sold to consumers.

As per regulation 5 and the first schedule of the above regulations, the maximum mark-up cannot exceed 35% with a special allowance of 2%.

We also have the Consumer Protection (Maximum Recommended Retail Price) (Code of Practice) Regulations 2008, which provide for the maximum recommended retail price of goods although no specific mention is made as regards pharmaceutical products.

4.2 Initial Price Negotiations

There are no initial price negotiations.

4.3 Public Funds

Costs of pharmaceutical products are met by public funds only when the products are delivered by public hospitals.

4.4 Cost-benefit Analysis

Prices in Mauritius are determined by the following:

  • country of origin;
  • CIF value as per invoice;
  • rate of exchange (as per receipt); and
  • quantity invoiced and landed.

The above would be the cost price before any mark-up. The seller then adds a mark-up as stated in 4.1 Setting and Controlling Prices.

4.5 Restrictions on Costs Grounds

There are no such restrictions.

4.6 Payment to Dispensing Pharmacists

The customer would pay the pharmacists. As per section 21(2) of the Pharmacy Act 1983, the pharmacist cannot substitute prescribed products.

5.1 Governing Rules

Section 41 of the Pharmacy Act 1983 states as follows:

“No person shall advertise any pharmaceutical product intended for human or veterinary use except in such technical or professional publications, as may be approved by the Board.”

Reference to the “Board” here is reference to the Pharmacy Board.

There cannot be promotion and marketing of pharmaceutical products to the general public.

Please note that there are no specific rules for prescription-only products.

Please also note that there are no specific rules governing the promotion and marketing of medical devices.

5.2 Breaches of the Promotional Rules

A breach of section 41 of the Pharmacy Act 1983 as specified above is considered a criminal offence and is enforced by the courts.

5.3 Sanctions for Breaching Promotional Rules

Any person who commits an offence under section 41 as specified above will, on conviction, be liable to a fine not exceeding MUR10,000 and to imprisonment for a term not exceeding two years.
The court before which a person is convicted of the offence above may, in addition to any penalty imposed, order the cancellation or suspension of any certificate of registration, licence or permit in respect of which the offence was committed and the forfeiture of any pharmaceutical product which is the subject matter of the offence.

5.4 Length of Breach Proceedings

The length varies on a case-by-case basis.

5.5 Restrictions on the Provision of Gifts/Sponsorship

There are restrictions concerning public officials which are provided under the Prevention of Corruption Act 2002.
Any public official who solicits, accepts or obtains from another person, for himself or for any other person, a gratification for:

  • doing or abstaining from doing, or having done or abstained from doing, an act in the execution of his functions or duties;
  • doing or abstaining from doing, or having done or abstained from doing, an act which is facilitated by his functions or duties;
  • expediting, delaying, hindering or preventing, or having expedited, delayed, hindered or prevented, the performance of an act in the execution of his functions or duties;
  • expediting, delaying, hindering or preventing, or having expedited, delayed, hindered or prevented, the performance of an act by another public official, in the execution of the latter’s functions or duties; or
  • assisting, favouring, hindering or delaying, or having assisted, favoured, hindered or delayed, another person in the transaction of a business with a public body, shall commit an offence and shall, on conviction, be liable to penal servitude for a term not exceeding ten years.

Furthermore, any person who gives, agrees to give, or offers a gratification to a public official for:

  • doing or abstaining from doing, or having done or abstained from doing, an act in the execution of his functions or duties;
  • doing or abstaining from doing, or for having done or abstained from doing, an act which is facilitated by his functions or duties;
  • expediting, delaying, hindering or preventing, or having expedited, delayed, hindered or prevented, the performance of an act in the execution of his functions or duties;
  • expediting, delaying, hindering or preventing, or having expedited, delayed, hindered or prevented, the performance of an act by another public official in the execution of the latter’s functions or duties;
  • assisting, favouring, hindering or delaying or having assisted, favoured, hindered or delayed another person in the transaction of a business with a public body,
  • shall commit an offence and shall, on conviction, be liable to penal servitude for a term not exceeding ten years.

5.6 Requirement to Disclose Details of Payments

These details would be available in the general accounts of the company which are mandatorily filed.

6.1 Process for Obtaining an Authorisation

Section 36 of the Pharmacy Act 1983 provides as follows:

(1) No person shall, unless he holds a licence, manufacture any pharmaceutical product.
(2) Any person who wishes to obtain a licence under this section shall –
(a) make a written application to the Board; and
(b) furnish, in support of his application –
(i) the formula of each pharmaceutical product to be manufactured;
(ii) the technical description of the production process;
(iii) details of all quality control; and
(iv) such other information or documents as the Board may require.
(3) The Board may, on receipt of an application under subsection (2), grant the application on payment of the prescribed fee and on such conditions as it thinks fit or reject the application.
(4) Where the Board rejects an application under subsection (3), it shall notify the applicant of the reasons for its decision.
(5) No application for a licence to manufacture therapeutic substances shall be granted unless –
(a) there are adequate facilities for manufacture of sterile preparations;
(b) there is appropriate quality control of any therapeutic substance used and of the finished product; and
(c) the manufacture takes place under the supervision of a pharmacist, a pharmacologist or a chemist who proves to the satisfaction of the Board that he has adequate experience in the manufacture of the therapeutic substances.
(6) Every licence issued under this section shall be valid for a period of one year as from the date specified in the licence and may be renewed annually on payment of the prescribed fee.
(7) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing, require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.”
The Pharmacy Act 1983 does not provide for any requirements as regards the applicant.
The fees are MUR5,100 per annum.

6.2 Competent Authority

Section 42 of the Pharmacy Act 1983 provides that an inspector may, for the purpose of ensuring that the Pharmacy Act 1983 or any subsidiary enactment made under the Pharmacy Act 1983 is being complied with, visit and inspect such premises.

Furthermore, pursuant to section 36(7) of the Pharmacy Act 1983, the Pharmacy Board, where it is satisfied that a licensee has contravened this Act or any condition attached to his licence, may, by notice in writing, require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

6.3 Regulatory Measures

Upon being notified of possible counterfeits, it is the Pharmacy Board that conducts investigations. Actions can also be entered for breach of intellectual property rights.
Furthermore, inspections are carried out by officials of the Pharmacy Board and it is possible for any third party to report any counterfeit products.

7.1 Obtaining an Authorisation to Engage in Wholesale Trade

No person may operate a wholesale pharmacy unless:

  • he holds a licence;
  • there is a pharmacist who is in charge of the wholesale pharmacy on a full-time basis; and
  • the premises used for the wholesale pharmacy are distinctly separate from those of any other pharmacy.

Any person who wishes to obtain such a licence should make an application to the Pharmacy Board on the prescribed form.

The Pharmacy Board may, on receipt of such an application, grant the application on payment of the prescribed fee, being approximately USD170 (MUR5,100), and on such conditions as it thinks fit or reject the application.

Such a licence shall be valid for a period of one year as from the date specified on the licence and may be renewed annually on payment of the prescribed fee of approximately USD170 (MUR5,100).

7.2 Competent Aurthority

The Pharmacy Board is responsible for conducting inspections of wholesale distribution facilities. Inspections are conducted on a discretionary basis and there are no fees for same.

The inspector of the Pharmacy Board who visits and inspects the premises of a wholesaler may, where deficiencies are identified, seize and with the authority of the Pharmacy Board destroy any pharmaceutical product which is, in his opinion, unwholesome or unfit for use, and institute proceedings in respect of any offence under the Pharmacy Act 1983.

7.3 Authorisation to Trade in Pharmaceutical Products

A licence would be required even where the distributor does not physically handle or store the products.

7.4 Other Operators Required to Hold Licences/Authorisations

There are no other licences required.

7.5 Procedure for Marketing Imported Medicines

Our laws do not make any specific provisions relating to marketing. The only provisions existing in our laws relate to advertising as follows:

“No person shall advertise any pharmaceutical product intended for human or veterinary use except in such technical or professional publications, as may be approved by the Board.”

Reference to the “Board” here is to the Pharmacy Board.

7.6 Restrictions on Sales of Medicines at a Distance

Subject to what is stated below, no person may sell by retail any medicine or drug in any place other than a pharmacy.

A medical practitioner may sell any medicine or drug if he does not keep open shop and there is no pharmacy within a distance of 5 km from the place where he attends a patient.

The Minister of Health and Quality of Life may, after consultation with the Pharmacy Board, make regulations authorising the sale by retail in any place other than a pharmacy of such medicines or drugs as may be specified in those regulations. At the time of writing, the only regulations which exist are the General Retailers (Sale of Simple Medicines) Regulations 1989 whereby any person who holds a general retailer’s licence may apply to the Permanent Secretary to sell simple medicine (as defined in those regulations).

Based on the above, sales of medicines at a distance is not permissible under our laws.

8.1 Applicable Laws

The main applicable laws regulating intellectual property in Mauritius are:

  • the Patents, Industrial Designs and Trademarks Act 2002 (the “Patents Act”);
  • the Protection Against Unfair Practice (Industrial Property Rights) Act 2002;
  • the Copyright Act 2014; and
  • the Genetically Modified Organisms Act 2004.

The most commonly encountered issues by pharmaceutical products under the legislation are the breach of patent and trademark rights.

The legal requirements regulating patentability of an invention are set out under section 12 of the Patents Act as follows, namely the invention:

  • is new;
  • involves an inventive step; and
  • is capable of industrial application.

There are no specific requirements regarding pharmaceutical products.

8.2 Second and Subsequent Medical Uses

There are no specific provisions in the laws of Mauritius regarding second and subsequent medical uses.

8.3 Pharmaceutical Patent Infringement

There are no specific provisions under Mauritius laws regarding pharmaceutical patent infringement. Nonetheless, section 21 of the Patents Act provides the constitutive elements of patent infringement in general:
(1) Any exploitation of the patented invention in Mauritius by any person other than the owner of the patent, shall require the latter’s agreement.
(2) For the purposes of this Act, the “exploitation” of a patented invention shall mean –
(a) where the patent has been granted in respect of a product –
(i) the making, importing, offering for sale, selling and using the product;
(ii) stocking such product for the purposes of offering for sale, selling or using;
(b) where the patent has been granted in respect of a process –
(i) the use of the process;
(ii) the performance of any of the acts referred to in paragraph (a) in respect of a product obtained directly by means of the process.”

Nothing is specifically mentioned in the Patents Act about the marketing of the patentable product but it is implied from section 21 of the Patents Act that any exploitation that will include the “making, importing, offering for sale, selling or using” of the product must receive the agreement of the patent holder.

Activities in relation to the marketing of the product will not give rise to any infringement once approval has been received from the patent owner.

There is no provision for the threat of infringement mentioned in the Patents Act.

Nonetheless, an alternative way to seek redress to prevent a threat of infringement or imminent infringement is to apply to the Mauritius Revenue Authority (“MRA”).
Section 66A-E of the Customs Act 1988 provides for the protection of intellectual property rights (including patents) by the MRA. According to the MRA, the procedure is for right holders to apply in writing and, subject to the approval of the Director-General of the MRA, for customs to suspend clearance of goods suspected of infringing intellectual property rights.

The written request for intervention by customs is an essential document that allows customs to suspend the release of imported/exported goods that infringe an intellectual property right. In addition, the request for intervention also provides Mauritian customs with a sufficiently detailed description of the goods to which the intellectual property right applies, and with the particulars needed to contact the right holder at any time.

8.4 Specific Defences

Mauritius jurisdiction provides for Bolar/experimental exemption under the Patents Act. The Bolar exemption is dealt with in section 23 of the Patents Act.

Section 23 of the Patents Act provides for certain exceptions in circumstances of exploitation by government or person thereby authorised:

“Where the competent authority:
(a) is satisfied that the public interest including, national security, nutrition, health or the development of other vital sectors of the national economy so requires; or
(b) has, on the application of any party, determined that the manner of exploitation, by the owner of the patent or his licensee, is anti-competitive and that it is necessary to remedy such anti-competitive practice;
it may, upon a request being made, authorise, even without the agreement of the owner of the patent, authorise a Government agency or a third person to exploit the patented invention.”

Statutory protection exists to the classic exploitation of a patent holder’s rights. The Patents Act provides clear-cut defences to product which are patentable on the grounds of public interest and national security, nutritional health or the development of other vital sectors of the national economy or where someone has made an application seeking the consent or authorisation of the patent owner to exploit the product in any such manner.

Such provisions act as defences to the exploitation of products which falls under protection of patentability.

The Pharmacy Act 1983 creates specific obligations on both importers and manufacturers before pharmaceutical products are put for sale on the market.

Licences must be sought from the Pharmacy Board for pharmaceutical products which are:

  • imported before they are put for use on the market; or
  • manufactured before they are put for use on the market.

According to section 25 of the Pharmacy Act 1983, it is compulsory for the importer of pharmaceutical products to comply with requirements such as:
“25. Registration of pharmaceutical product
(1) (a) Subject to subsection (6), no person shall import a pharmaceutical product unless it is registered with the Board.” (“Board” refers to the Pharmacy Board)
“(2) (a) A person who wishes to register a pharmaceutical product shall make an application to the Board in the prescribed form.”

It is mandatory for a pharmaceutical product to be registered. Such registration is a type of licence that is given upon satisfaction of the quality of the pharmaceutical product before it is put on the market for sale.

The procedure for registration of the product must be made by application to the Pharmacy Board.
Section 36 of the Pharmacy Act 1983 expressly provides for the granting of licence for the manufacture of pharmaceutical products.

“36. Licence for manufacture
(1) No person shall, unless he holds a licence, manufacture any pharmaceutical product.
(2) Any person who wishes to obtain a licence under this section shall –
(a) make a written application to the Board; and
(b) furnish, in support of his application –
(i) the formula of each pharmaceutical product to be manufactured;
(ii) the technical description of the production process;
(iii) details of all quality control; and
(iv) such other information or documents as the Board may require.”

8.5 Parties that can Bring Infringement Proceedings

The patent owner in whom the patent rights are vested is the person entitled to bring proceedings for infringement of patent rights.

Damages and interests are remedies which can be sought by the plaintiff. The right holder can avail himself of civil remedies such as injunction as well in the case of imminent infringement as elaborated above.

Such remedies are statutorily cited in section 21(3) of the Patents Act.

The possible courses of action for a patent infringement are as follows:

  • Make an application at the MRA to impose a restriction on the pharmaceutical product.
  • Put the wrongdoer on notice by instructing an attorney to send a letter condemning the act of infringing the said right and threatening recourse to civil proceedings if the prejudice caused is not repaired.

By virtue of section 25 of the Patents Act, which regulates the defence of invalidation:
“(1) Any interested person may request the Tribunal for Industrial Property (Tribunal) to invalidate a patent.
(2) The Tribunal may invalidate the patent where the person requesting the invalidation proves that any of the requirements of sections 11, 12 and 14 have not been fulfilled or where the owner of the patent is not the inventor nor his successor in title.
(3) Any invalidated patent or claim or part of a claim shall be regarded as null and void from the date of the grant of the patent.
(4) The final decision of the Tribunal shall be notified to the Controller who shall record it and publish a reference thereto as soon as possible.”

The Tribunal may invalidate the patent where the person requesting the invalidation proves that any of the requirements of sections 11 (Definitions), 12 (Patentable inventions) and 14 (Application) have not been fulfilled or where the owner of the patent is neither the inventor nor successor in title.

8.6 Procedures Available to Potential Generic Entrant

Such procedures are not provided under Mauritian laws.

8.7 Patent Term Extension

The legal requirements for obtaining a patent term extension are laid down in section 22 of the Patents Act, which provides:

“Duration

(1) Subject to subsection (2), a patent shall expire 20 years after the filing date of the application for the patent.
(2) In order to maintain the patent or patent application, an annual fee as may be prescribed shall be payable to the Controller for each year, following the year of the filing date.
(3) If the annual maintenance fee is not paid in accordance with the provisions of subsection (2), the patent application shall be deemed to have been withdrawn and the patent shall lapse.”

Third parties can ultimately challenge the patent term extension if it can be proved that the patent owner has failed to pay the annual fee.

9.1 Restrictions on Trade Marks

Section 36 of the Patents Act also covers intellectual property such as trademarks. Trademark protection also applies to pharmaceutical products. De facto trademark protection for pharmaceutical products applies when the trademark has been duly registered as firmly stipulated under section 36 of the Patents Act.

9.2 Legislation and Procedures

The Patents Act offers legal protection against counterfeit pharmaceutical products in all types of intellectual property such as patents as well as trademarks.

Once a trademark has been acquired in terms of section 36 of the Patents Act, it is deemed to be owned by the trademark owner. If there is any potential infringement, then the trademark owner can bring a civil claim to seek damages or even make an application for an injunction.

An alternative way to seek redress for trademark infringement is to apply to the MRA:
Section 66A-E of the Customs Act 1988 provides for the protection of intellectual property rights by MRA customs. According to the MRA, the procedure is for right holders to apply in writing and, subject to the approval of the Director-General of the MRA, for customs to suspend clearance of goods suspected of infringing intellectual property rights.

The written request for intervention by customs allows customs to suspend the release of imported/exported goods that infringe an intellectual property right. In addition, the request for intervention also provides Mauritian customs with a sufficiently detailed description of the goods to which the intellectual property right applies, and with the particulars needed to contact the right holder at any time.

9.3 Importation and Distribution Restrictions

Section 40 of the Patents Act 2002 provides:

“Any interested person, other than the registered owner, who intends to use a registered mark, in relation to any goods or services for which it has been registered, shall require the agreement of the owner.”

This section expressly states that no trademark products may be used in terms of import and export if it is proved that such products have been registered under a particular trademark.

For more details, reference can be made to the case of Reckitt & Colman Ltd v Dauhoo.M.N (2012 SCJ 495) where it was held that authorisation and consent must be sought from the right owner who is the trademark owner and not from other ancillary sources such as the Ministry of Health.

It is to be noted that the above case does not make reference to pharmaceutical products or relate to infringement.

9.4 IP Protection

The IP protection would be extended to trade dress or design of pharmaceutical products.

10.1 Activities Constituting Infringement

The issue has been raised in Reckitt & Colman Ltd v Dauhoo.M.N (2012 SCJ 495) as regards parallel importation. In fact parallel importation is not illegal but, before the exploitation of any pharmaceutical product, it is imperative that the agreement of the patent owner or trademark owner is sought. Henceforth, it is a prerequisite that the consent or authorisation of the patent owner is given so that parallel importing can be authorised without infringing the competition law.

The law already provides in sections 41 to 50 of the Competition Act 2007 for restrictive business practices.
“Section 41. Horizontal agreements
(1) For the purposes of this section, an agreement, or a provision of such agreement, shall be collusive if:
(a) it exists between enterprises that supply goods or services of the same description, or acquire goods or services of the same description;
(b) it has the object or effect of, in any way:
(i) fixing the selling or purchase prices of the goods or services;
(ii) sharing markets or sources of the supply of the goods or services; or
(iii) restricting the supply of the goods or services to, or the acquisition of them from, any person; and
(c) significantly prevents, restricts or distorts competition.
(2) Any agreement, or provision of such agreement, which is collusive under this section shall be prohibited and void.”

“Section 42. Bid rigging

(1) For the purposes of this section, an agreement, or a provision of such agreement, shall be collusive if one party to the agreement –
(a) agrees not to submit a bid or tender in response to an invitation for bids or tenders; or
(b) agrees upon the price, terms or conditions of a bid or tender to be submitted in response to such a call or request.
(2) Subject to subsection (3), any agreement, or provision of such agreement, which is collusive under this section shall be prohibited and void.
(3) This section shall not apply to an agreement the terms of which are made known to the person making the invitation for bids or tenders at, or before, the time when any bid or tender is made by a party to the agreement.”
“Section 43. Vertical agreements involving resale price maintenance
(1) Subject to subsections (2) and (3), a vertical agreement between enterprises shall, to the extent that it involves resale price maintenance, be prohibited and void.
(2) A supplier or producer may recommend a minimum resale price to a reseller of goods or services provided that the recommendation is not binding.
(3) Where a supplier or producer has recommended a minimum resale price to a reseller of goods and the resale price appears on the goods, the words “recommended price” shall appear next to the resale price.”

“Section 44. Non-collusive horizontal agreements

A horizontal agreement that is not collusive under section 41 may be reviewed by the Commission where:
(a) the parties to the agreement together supply 30 per cent or more, or acquire 30 per cent or more, of goods and services of any description on the market; and
(b) the Commission has reasonable grounds to believe that the agreement has the object or effect of preventing, restricting or distorting competition.”

“Section 45. Other vertical agreements

A vertical agreement that does not involve resale price maintenance may be reviewed where the Commission has reasonable grounds to believe that one or more parties to the agreement is or are in a monopoly situation that is subject to review under section 46.”

“Section 46. Existence of monopoly situation

(1) A monopoly situation shall exist in relation to the supply of goods or services of any description where:
(a) 30 per cent or more of those goods or services are supplied, or acquired on the market, by one enterprise; or
(b) 70 per cent or more of those goods or services are supplied, or acquired on the market, by 3 or fewer enterprises.
(2) A monopoly situation shall be subject to review by the Commission where the Commission has reasonable grounds to believe that an enterprise in the monopoly situation is engaging in conduct that:
(a) has the object or effect of preventing, restricting or distorting competition; or
(b) in any other way constitutes exploitation of the monopoly situation.
(3) In reviewing a monopoly situation, the Commission shall take into account –
(a) the extent to which an enterprise enjoys or a group of enterprises enjoy, such a position of dominance in the market as to make it possible for that enterprise or those enterprises to operate in that market, and to adjust prices or output, without effective constraint from competitors or potential competitors;
(b) the availability or non-availability of substitutable goods or services to consumers in the short term;
(c) the availability or non-availability of nearby competitors to whom consumers could turn in the short term; and
(d) evidence of actions or behaviour by an enterprise that is, or a group of enterprises that are, a party to the monopoly situation where such actions or behaviour that have or are likely to have an adverse effect on the efficiency, adaptability and competitiveness of the economy of Mauritius, or are or are likely to be detrimental to the interests of consumers.

“Section 47. Merger situation

(1) For the purposes of this Act and subject to subsection (2), a merger situation means the bringing together under common ownership and control of 2 or more enterprises of which one at least carries its activities, in Mauritius, or through a company incorporated in Mauritius.
(2) For the purpose of subsection (1), enterprises shall be regarded as being under common control where they are –
(a) enterprises of interconnected bodies corporate;
(b) enterprises carried on by 2 or more bodies corporate of which one person has or groups of persons have control; or
(c) 2 distinct enterprises, one carried on by a body corporate and the other carried on by a person having control of that body corporate.
(3) Any person may be treated as bringing an enterprise under his control where –
(a) he becomes able to control or materially to influence the policy of the enterprise, but without having a controlling interest in it;
(b) being already able to control or materially to influence the policy of the enterprise, he acquires a controlling interest in it; or
(c) being already able materially to influence the policy of the enterprise, he becomes able to control that policy.
(4) Where 2 or more enterprises intend to be in a merger situation, any one of the enterprises may apply to the Commission for guidance as to whether the proposed merger situation is likely to result in a substantial lessening of competition within any market for goods or services.”

“Section 48. Merger situations subject to review by Commission

A merger situation shall be subject to review by the Commission where –
(a) all the parties to the merger, supply or acquire goods or services of any description, and will following the merger, together supply or acquire 30 per cent or more of all those goods or services on the market; or one of the parties to the merger alone supplies or acquires prior to the merger, 30 per cent or more of goods or services of any description on the market; and
(b) the Commission has reasonable grounds to believe that the creation of the merger situation has resulted in, or is likely to result in, a substantial lessening of competition within any market for goods or services.”

“Section 49. Share of supply criteria

(1) For the purpose of establishing whether the share of supply criteria set out in sections 44, 45, 46 or 48 are satisfied, the share of the group as a whole is to be used where an enterprise –
(a) is a subsidiary of a group; or
(b) is otherwise party to agreements by which enterprises are interconnected within a group.
(2) For the purpose of establishing whether the share of supply criteria set out in sections 44, 45, 46 or 48 are satisfied, the Commission may also take into account any cross-shareholding between or amongst groups.”

“Section 50. Assessment of restrictive business practices

(1) The Commission shall, in relation to every agreement falling under Sub-Part I of this Part, establish whether, on the facts of the case, the parties to the agreement have infringed the prohibition imposed under that Sub-Part.
(2) When reviewing a matter falling within Sub-Parts II, III and IV of this Part, the Commission shall have regard to the desirability of maintaining and encouraging competition and the benefits to be gained in respect of the price, quantity, variety and quality of goods and services, and shall first determine whether competition in any market is adversely affected in that, in the case of –
(a) a reviewable restrictive agreement, the agreement has the object or effect of preventing, restricting or distorting competition;
(b) a monopoly situation, the conduct of one or more parties –
(i) has the object or effect of preventing, restricting or distorting competition; or
(ii) in any other way constitutes exploitation of the monopoly situation, having regard to the factors set out in section 46;
(c) a merger situation, the creation of a merger situation has resulted, or is likely to result, in a substantial lessening of competition within any market or markets for goods and services.
(3) Where the review of the matters described in subsection (2) leads to a finding by the Commission that there are adverse effects for competition in a particular case, it shall, before deciding on any appropriate remedial action to be taken as provided for under Part VI, consider –
(a) if any of the offsetting public benefits specified in subsection (4) are present; and
(b) whether and to what extent the benefits, if they are present, should be taken into account in determining the remedial action to be taken.
(4) A benefit shall be considered for the purposes of subsection (3)(a) if it is shown that the effects of any absence, prevention, restriction or distortion of competition are outweighed by specific gains in respect of –
(a) the safety of goods and services;
(b) the efficiency with which goods are produced, supplied or distributed or services are supplied or made available;
(c) the development and use of new and improved goods and services and in the means of production and distribution; or
(d) the promotion of technological and economic progress, and the benefits have been or are likely to be shared by consumers and business in general.”

10.2 Pay-for-Delay Agreements

There is no case law as regards to pay-for-delay agreements.

10.3 Life Cycle Strategies

There is no case law as regards life cycle strategies.

10.4 Proceedings for Breach of Competition Law

A person whose rights are deemed to have been infringed has the locus standi to bring a claim on the ground of breach of competition law before the Competition Commission. Section 5 of the Competition Act provides that:

“The Commission shall –

(a) conduct, as required, any hearings with interested persons or parties;
(b) determine whether a restrictive business practice is occurring or has occurred;
(c) determine such penalty or other remedy as it thinks fit to impose in response to an identified anti-competitive practice and what action an enterprise should take to ensure compliance with the penalty or remedy.”

11.1 Key Contractual Terms

There is no specific template and these agreements would be standard.

11.2 Customary Deal Terms to Bridge the Valuation Gap

Such deal terms are drafted on a case-by-case basis.

11.3 Purchase Price Adjustments

Such price adjustments are drafted on a case-by-case basis.

11.4 Deal Protection Terms

Such deal protection terms are drafted on a case-by-case basis.

11.5 Local Antitrust Approval

Please refer to 10.1 Activities Constituting Infringement.

11.6 Tax Treatment of Asset Deals Versus Share Deals

Registration duty and land transfer tax are the two taxes which are leviable on the transfer of assets (including shares).

Registration duty is leviable on the registration of any deed of transfer with the Registrar General of Mauritius, which is the body responsible for the registration of deeds of transfer and for the collection of duties and taxes on such deeds. The rate of registration duty leviable varies from asset to asset. Some assets attract a certain percentage of duty whereas others attract a proportional duty.

Land transfer tax, on the other hand, is tax levied on the transfer of any freehold or leasehold immovable property or any right or interest in any freehold or leasehold immovable property. The foregoing definition includes a deed witnessing the transfer of shares in or successive transfers of shares of a company which owns:

  • any freehold or leasehold immovable property; or
  • any shares in any other company or successive company which reckons amongst its assets such property,
    which results in a change of the control of that company; or any increase in shareholding of the controlling shareholder within a period of 12 months from the date of the change of control.

Land transfer tax is normally levied at the rate of 5% on the value of theshares transferred; or at the option of the transferor and transferee jointly, in such proportion as the number of shares transferred bears to the total number of shares issued by the company, without taking into account the number of shares, if any, issued to transferee during the period of three years immediately preceding the date of transfer, on the open market value of the immovable property comprised in the assets of the company or on the value of the shares transferred, whichever is the lower.

In the case of a transfer of shares which meets the definition set out above, land transfer tax at the rate of 5% is levied for such transfer of shares and registration duty at the rate of 5% is levied.

In any other case, a transfer of shares attracts only a nominal registration duty of approximately USD10.

11.7 Protection of Licensees

There is no specific protection afforded to licensees under our laws in the case of insolvency of a licensor. At the time of reaching an agreement, the licensees should ensure that the terms of the agreement are carefully drafted to protect them against an insolvency.

12.1 Focus of Investigations

The main focus is generally on frauds, counterfeits and illegal supply.

12.2 Important ‘Do’s’ and ‘Don’ts’

A local person is usually appointed to conduct an investigation and test purchases. Should there be any fraud or misrepresentation, the matter is then referred to the police.

There are no relevant “dont’s” as regards investigation.

12.3 Recent Landmark Cases

The cases entered before our courts are mainly objections made by the relevant authorities to the setting up of a pharmacy.

In Socimed Limited v The Honourable Minister of Health 2000 SCJ 309, the issue was whether Tramal could be imported in Mauritius because the authorities averred that they could not control the misuse of Tramal.

In City Pharmacy Company Ltd v Pharmacy Board 2000 SCJ 101, the issue was that, following an investigation, it was found that the representative of the applicant had sold 5,640 tablets of Artane (benzhexol) to the public out of which only 31 tablets were sold on prescription as required by the Pharmacy Act. The pharmacy was subsequently ordered to close down.

12.4 Distinct Characteristics of Investigations in Pharma Sector

In Mauritius, counterfeit pharmaceutical products are not available on the streets. Therefore, the investigation only needs to be focused on the few pharmacies in Mauritius.

Further, it is to be noted that in Mauritius there are few wholesalers for pharmaceutical products.

13.1 Regime for Injury Caused by Pharmaceutical Products

There is no specific legal regime. The liability will be under tort under the Mauritian Civil Code. Any person who avers that damages have been caused needs to prove the causal link between the product and the damages caused as well as the method of computation of the damages.

13.2 Prerequisites for Potential Liability

It is liability-based and it will also amount to a criminal offence if there is a breach of statutory obligations.

In the case of tort, the manufacturer, importer and seller may all be joined as parties if there is an inherent defect in the product.

However, if the liability is due to a sole party’s fault (for example improper storage), then only the person responsible forthis would be sued.

13.3 Standard of Proof for Causation

Under Mauritian laws, for civil proceedings, the standard is the balance of probabilities. There is no presumption of causation under Mauritian laws.

13.4 Market Share Liability

A party would be held liable only if it is proved that the damage had arisen from a specific product. There is no market share liability in Mauritius.

13.5 Defences for Fault Based or Strict Liability

The two main defences available are:

  • force majeure; and
  • exclusive fault of the victim.

The two above have as elements that the liability would be unforeseeable, irresistible and not linked to the parties.

If it can be proven that the above characteristics are present, these would then constitute a defence.

There are no specific defences as regards pharmaceutical products and there is no case law on the “development risks defence”.

The good faith of the manufacturer, importer or seller can, however, be submitted, since the risks were not known at the time of manufacture. However, those parties must show that all necessary precautions had been taken to avoid the damage.

13.6 Regulatory Compliance Defence

This has not been tested before the Mauritian courts.

13.7 Limitation Period

There is no limitation period as such for pharmaceutical product liability claims but any manufacturer or seller would have a ten-year period regarding any inherent defect in the product.
Furthermore, such types of personal actions are time barred after ten years.

13.8 Recoverable Damages

Under Mauritian laws, one can ask for material and moral damages. The material damages are usually proved by way of invoices and receipts.

As regards future damages, it has been held that, if the party seeking damages can show that expenses are likely to be incurred (for example future operations), the court may award these.

13.9 Maximum Limit on Damages

There is no maximum limit.

13.10 Recent Decisions

There are no pharamceutical product liability cases under Mauritian laws.

13.11 Trial

The trial will be heard solely before a judge.

13.12 Obligation to Disclose Documents

There is the requirement of full and frank disclosure.

13.13 Class/Group Action Procedure

At the time of writing, there have been no class or group actions in Mauritius.

13.14 Funding of Claims

The Legal Aid Act allows a person to be represented by counsels whose fees are paid by the state. It is to be noted that an applicant for legal aid would need to show that he does not have the financial means as required by the Legal Aid Act.

There is nothing under our laws to prohibit third party funding.

13.15 Potential Changes to Legal Regime

We are not aware of any potential amendments to the laws governing pharmaceutical product liability.