Que devez-vous savoir pour assurer la réussite des envois en Afrique du Nord ?
Jusqu’ici, l’Afrique du Nord a été une région sous-utilisée en matière d’essais cliniques.
Whilst obviously part of the African continent North Africa is very definitely its own distinct region, very much divided from sub-Saharan Africa, and most definitely not part of the Middle East, (although the population of 423 million represents some 58% of the Arab League which spreads from the Middle East and over the whole of Northern Africa.) North Africa has been up till now a much under used area when it comes to clinical trials.
The Sahara desert to the South is 3,6 million sq. miles, and is the World’s third biggest desert and largest hot desert. The Atlas Mountains extend for 1600 miles, separating the Sahara from the Mediterranean coastline, and this feature dominates the region. The area has been inhabited by man for millennia and there are cave paintings at Tassili n’Ajjer in Algeria dating back to between 8000-4000 BCE. The area has been under the control of many nations including French, Spanish, Arab, and Italian, and this is reflected in the many languages spoken across the countries, dominated for the greatest area by French.
Egypt leads the way for clinical trials with (according to clinicaltrials.gov) almost 1200 either having taken place or in progress, which is no mean feat particularly given the hiatus experienced for new trials during the political uncertainty of Arab Spring. It is the most populous country in the region, at around 80 million, which has clearly been a heavy influence.
Tunisia and Morocco are at 195 and 80 studies respectively, then Algeria at 75, and the Sudan trailing with 22. The remainder of countries, including Libya (and some tiny Spanish territories), have a handful of studies and at the present time are unlikely to be amongst first choice destinations for most pharmaceutical companies and their clinical trials. It is estimated that it will take at least 10 years to rebuild Libya’s infrastructure after the 2011 war.
Concentrating on Egypt for the moment it is clear that the country operates a complex healthcare system, with public, NGO, religious and charitable institutions all providing services. Spend is approximately 5,1% of GDP on health which is #142 on the world rankings. Control is in the hands of the Ministry of Health, and they run a complex finance mechanism with some state input, some health insurance options, and a further contribution by the patient or their families. Egypt produces over 90% of the pharmaceuticals it consumes and pharmaceuticals account for just over one-third of all health spending. Publicly produced medicines are heavily subsidized. There is a clear divide between rich and poor and approximately 25% of Egyptian children under age five have chronic malnutrition. Life expectancy is around 71 years for men and 76,5 for women, which is very much consistent across the region. In 2009, there were 16,04 physicians and 33,80 nurses per 10 000 inhabitants, and 0,5 beds per 1000 population. Applications to run trials must be done sequentially process (LEC and then the MOH)
Some consideration towards creating systems for importing clinical trial drugs has been made, but the process remains somewhat variable once shipments arrive into Cairo.
Import Paper Work
Certificate of Origin:
May be required for certain items - must be checked on a case by case basis.
Is always required to import pharmaceuticals and only the consignee can apply for the import licence. Officially the consignee can only make the application at the MoH only once the shipment has arrived at the airport, and once they have the original invoice, MAWB and HWB which must be presented for the application. For temperature controlled shipments it is often possible to apply for and to obtain the import licence based on a copy of the invoice, i.e. before physical shipping takes place. The import licence takes a minimum of one week but can be several weeks or longer. In very rare cases, the MoH has refused to issue an import licence. It is strongly recommended to seek advice prior to shipping.
For low value shipments: 2 original proforma invoices between the shipper to consignee. Zero value is not acceptable.
For high value or commercial shipments: 2 original commercial invoices from shipper to consignee.
The invoices need to include
- Consignee company name and address on invoice which must be exactly the same as the holder of the import licence and of the name used on the MAWB
- Shipper information including company name, full address, phone, fax, email address and website.
- Batch number and detailed product name.
- For shipments originating from Non-European countries; the original invoices must be legalized (with stamp or signature) by Chamber of Commerce at origin.
Non compliance to any of these requirements will cause delay and a possible fine.
Power of Attorney
A copy of the consignee's company registration certificate is always required to clear non-documents.
When including a temperature recorder in shipments, the MoH requires the product name and batch number (as a minimum) to be saved as customized data, when the temperature recorder is programmed. Information is checked against the customs invoice at the point of import. Failure to comply may result in MoH refusing the use of the product.
In cases where the multiple batches of materials are used inside the same packaging and the numbers cannot all be programmed onto the recorder then it is possible to use multiple recorders (even if the consignment is just one box) and add different batch numbers to the monitor, or to add the invoice number, MAWB number and the name of consignee to the recorder data instead and cross reference on the paperwork. If the batch numbers fit they should always be used preferentially.
Clearance time (if everything is in order) should be eight hours, and customs operate every day except Fri. It is strongly recommended to add the external temperature requirements on the MAWB or shipments will not be stored correctly. The handling agent is only authorised to follow the instructions on the airline paperwork. The temperature control rooms in Cairo airport have no temperature recording system. In tests our representative concluded that these areas were not set/working correctly, so extra care should be taken when selecting packaging. Additionally the refrigerators (applies to all handlers) particularly during the summer may have reduced performance. This is due to the facilities being full and the doors often being opened to the heat of the daytime. Shipments on dry ice are accessible for replenishment during clearance pending release.
Tunisia requires an Import Permit for every shipment, which is issued by the DPM (Direction of the Pharmacy and Medicine). The consignee must apply with an invoice for each shipment. As French is the main written language used it is vital to have through business and trial specific language skills and understanding to be able to make the application.
If we compare this with Algeria, they have a longer term approach to the granting of import licences. The consignee needs to apply for import authorisation with the MoH (which takes approximately 15 -20 days). The company must preregister with customs in advance, before any application can be made. Once obtained, the authorisation paperwork must be sent to customs, together with a statement from the consignee. The Head of Customs will then give their approval and inform customs at the airport. This approval is given for a certain period of time typically a year, and covers all the shipments for a study.
Across the whole region preplanning and attention to detail are key for success in shipping. The temperature challenges, which are not limited to the summer, need extra care in instructing the handling of shipments, but relying on temperature controlled areas is probably rather optimistic. Choosing robust packaging is a sensible method of ensuring temperature compliance.