Pharmaceutical advertising regulation and medical device advertising in Saudi Arabia

1.1 Medicines

In general, the Implementing Regulations of Medical Establishments and Products Law of 2019 (the “Regulations”) briefly address advertisements of prescriptive and non-prescriptive medicines.

The Rules and Procedures for Approving Advertising of Non-prescriptive Pharmaceutical Products (the “Rules”) deal with the advertisement and marketing of (i) non-prescriptive skin-related pharmaceutical products for humans, (ii) herbal products, and (iii) non-prescriptive veterinary products.

1.2 Medical devices

Medical devices in KSA are subject to:

• Medical Devices Interim Regulations (“Interim Regulations”) 1 Issued by Saudi Food and Drug Authority Board of Directors Decree Number (1-8-1429) and dated 27 December 2008, and amended by Saudi Food and Drug Authority Board of Directors Decree Number (4-16-1439) dated 27 December 2017 and published in Umm Al-Qura Journal year (86) issue number (4249) dated 17 April 2009.
• MDS—G11 Guidance on Medical Devices Advertising Requirements 2 Version Number:1.1, Version Dated 1/5/2016 issued by the Saudi Food and Drug Authority (“SFDA”) “Guidance”).

Saudi Code of Pharmaceutical Promotional Practices in KSA (“Code”) largely addresses the relation between drug companies and manufacturers on the one hand and health practitioners on the other. The Code discusses the promotion of pharmaceutical products generally, regardless of whether such products are prescriptive or over the counter.

The Code is an ethical code for practicing pharmaceutical promotion. All pharmaceutical companies/plants working in KSA and in the health sector, physicians, and pharmacists either working in the private or public sectors should adhere to this Code.

The Code provides that the advertisement or promotion of pharmaceutical products in general should be in conformance with the Islamic Sharia, social traditions, ethical, and cultural fundamentals of this society.

The Code further provides that a pharmaceutical product must not be promoted for sale or supply before issuing the marketing authorization licence and all advertising and promotional materials for a pharmaceutical product must be approved and certified by the SFDA.

There is another Code of Ethics for Healthcare Practitioners, although it does not provide for advertisement of medical devices or medicines.

Finally, it is relevant to note Article 10/A of the Law of Practicing Healthcare Professions which provides that “A healthcare professional is prohibited from advertising or promoting himself, directly or indirectly”, and the Implementing Regulations, Article 10/A states that “the health practitioner should avoid the means of publicity that have commercial nature and refrain from consultations that are not based on a scientific basis..."

For medicines, the Rules provide that prior approval of the SFDA should be sought before any advertisement of pharmaceutical products is made to the general public. Likewise, the Code provides that a marketing authorisation licence should be sought before promoting pharmaceutical products, and that the promotional materials should be in line with the usage as approved by the SFDA.

With regard to the advertisement of medicines to the general public, the Rules provide that there is a non-refundable fee payable to the SFDA for seeking approval for the underlying advertisements.

Advertising or marketing material for medical devices should likewise be approved by the SFDA before its use and it must be submitted on an ongoing basis (“MDMA”). Approval from the SFDA can be obtained in two ways and there is no fee for seeking approval for the advertisement of medical devices.

There are two situations for submitting of advertising and marketing material:

1. as part of MDMA procedure, the applicant is required to submit all the advertising and marketing material that will be used in the KSA. This situation is applicable when the advertising and marketing material:
   1. is prepared and submitted by a local manufacturer, or
   2. is prepared by an overseas manufacturer and submitted by its authorised representative, and
2. separate approval, which is called a medical devices advertising licence (“MDAL”). This situation is applicable when the advertising and marketing material are prepared and submitted by a licensed distributor or a registered healthcare facility on its own behalf.

Yes, the advertising and marketing of prescription-only and over-the-ounter medicines is regulated differently in KSA. It is relevant to note Article 36 of the Regulations, which prohibits the advertisement of prescriptive pharmaceutical and herbal products, with the exception of publication in magazines, conferences and workshops and scientific publications that are directed to medical practitioners. Article 36 further provides that non-pharmaceutical and herbal products may only be advertised after the approval of SFDA.

The Code deals with promotion and advertisement in the context of medical practitioners and covers pharmaceutical products generally whereas the Rules specifically deal with the advertisement and marketing of (i) non-prescriptive skin-related pharmaceutical products for humans, (ii) herbal products, and (iii) non-prescriptive veterinary products.

Further, the Rules clarify at the outset that advertising may only be carried out for non-prescriptive products. 3 (Rule 2(1)) It is understood from the Rules that ‘advertisement’ is discussed in the context of advertising to the general public.

5.1 Medicines

As per the Rules, the following are some of the restrictions and controls applicable on the advertisement of non-prescriptive pharmaceutical products to the general public:

• Only non-prescriptive products can be advertised.
• The product should be registered with the SFDA.
• Advertisements should only be made during the validity of the respective approval. The validity of an approval for advertising products is one Hijri 4 Islamic year.
• Advertisements should comply with the principles of Sharia and should not violate public decency.
• Advertisements should not provide incorrect or misleading information, or information that is unclear and that is susceptible to inappropriate interpretation.

5.2 Medical devices

Article 41 of the Interim Regulations provides for restrictions applicable to the advertising of medical devices as follows:

• The advertising of a medical device for which the SFDA has not issued a marketing authorisation is prohibited.
• All advertisement material must be approved by the SFDA.
• The advertising material must not mislead the user regarding the performance of the medical device as specified by the manufacturer.
• The advertising to the general public, including on the internet, must avoid misleading lay persons.
• Any advertising to persons qualified to use medical devices must include the relevant information compatible with their specific needs.
• Medical sales representatives must have sufficient knowledge to be able to provide appropriate information about the medical devices they promote.

As per the Code, below are some of the restrictions and controls on promotion of pharmaceutical products:

• Promotional material should comply with the principles of Sharia and societal norms.
• Exaggeration of the characteristics of pharmaceutical products should be avoided, unless such claim could be scientifically proven.
• The effectiveness or quality of pharmaceutical products registered in KSA should not be put in doubt.
• A claim that a pharmaceutical product does not have side effects should not be made, unless it can be scientifically proven.

Likewise, the Interim Regulations provide that the medical sales representative/promoters must have sufficient knowledge to be able to provide appropriate information about the medical devices they promote.

7.1 Medicines

With regard to the medicines, the Code provides that the promotional material of pharmaceutical products should include, among other things, the following:

• Trade name and generic name.
• Name and address of the company/agent responsible for marketing.
• Usage, dosage and method of use.

7.2 Medical devices

As regards the medical devices, the Interim Regulations and Guidance does not distinguish advertisements directed to lay persons and healthcare professionals but does require that the advertising should not mislead the lay person.

 Guidance provides that the advertising and marketing material must:

• not mislead the user regarding the performance of the medical device as specified by the manufacturer. o avoid misleading lay persons, when advertising to the general public, including on the internet.
• include the relevant information compatible with professional specific needs, when advertising to professionals.
• include the following:
  • name of device.
  • name and address of manufacturer. o document control reference number (it is required in case of as part of MDMA procedure).
  • medical devices advertising licence number (it is required in case of separate approval).
• not include the SFDA logo nor the establishment National Registry Number, that is issued through SFDA’s MDNR, but may include the Medical Device National Listing Number issued through SFDA’s MDMA.
• not include phrases that might be misinterpreted. o not violate the Saudi law of “Printed Materials and Publication”.

Further, the Guidance provides that the advertising and marketing material must be in English, where it is intended for professionals, but for the lay persons it should be in Arabic.

8.1 Medicines

As per the Rules, the following is some of the information that must appear in advertising for non-prescriptive pharmaceutical products to the general public:

• The approval number of the SFDA should appear on the advertisement.
• The trade name of the product and the active ingredient.
• The statement: “this product has several side effects, for more information please consult a doctor or a pharmacist and read the information leaflet”.

Certain statements are to be included in advertisements depending on the nature of the product being advertised.

8.2 Medical devices

Please see response in 7.2.

The Rules provide that the content of advertisements of non-prescriptive products should be in line with the patient information leaflet as well as the summary of product characteristics.

The Code further provides that any medical claim should be supported by scientific reference. Scientific studies and references should be clearly reproduced leaving no room for misinterpretation.

For medical devices, the SFDA requires, among other things, the information about the relevant medical device along with the scientific supporting documents or evidence with reference for any medical claim.

There are no specific rules for comparative advertisement of medicines and/or medical devices except that the Rules provide that advertisements for non-prescriptive pharmaceutical products should not harm the reputation of other products or provide incorrect information.

The Code provides that any comparison between different pharmaceutical products should be based on comparison points that are relevant to the product. The advertising and comparison should not be misleading or give a dishonest impression about the other products.

The Rules provide that online advertisements for non-prescriptive pharmaceutical products should be available on the webpage provided by the applicant, and should not redirect visitors to other websites. It is further provided that online advertisements should not include information about medical practitioners.

With regard to the medical devices, Interim Regulations provide that the advertising and marketing material must avoid misleading lay persons, when advertising to the general public, including advertisements on the internet.

As regards the advertisement of medicines, no enforcement mechanism is provided in the Rules regarding the failure to comply therewith when advertising to the general public. However, Article 37 of the Regulations provides that the SFDA may impose the following penalties in respect of violations of the Regulations:

• Warning;
• A fine not exceeding SAR 100,000/-;
• Closure of the medical establishment for up to 60 days; and/or
• Cancelling the licence of the establishment.

For medical devices, the SFDA is fully authorised to ensure compliance with the advertisement provisions, failing which the SFDA may withdraw or restrict the medical devices including taking any of the following actions:

• Suspending the licence.
• Terminating the licence.
• Recalling the product from the market.
• Withdrawing the marketing authorisation.

SFDA releases from time to time various draft rules and regulations for public commentary before these drafts become effective. Currently, we are not aware of any future developments that may affect the responses above.