The FAMHP and the Belgian association of unions for medical practitioners (ABSYM/BVAS) met this Wednesday, 16 April 2020, in a constructive and sincere atmosphere. The FAMHP explained that its teams are working hard to resolve the difficulties that certain hospitals have faced in obtaining supplies of medicinal products since the start of the COVID-19 pandemic. The emergency aid service was able to resolve temporary shortages encountered by hospitals.
At the start of the COVID-19 pandemic, some hospitals ordered excessive supplies of medicinal products in anticipation of a worst-case scenario. It quickly became apparent that daily demand, particularly in the case of medicinal products required by intensive care units, exceeded the supply of medicinal products available on the Belgian market.
Actions and solutions implemented by the FAMHP
For this reason, the FAMHP immediately made every effort to ensure a continuous supply of medicinal products. Since then, the FAMHP has:
- set up an identification system for all Belgian stocks of medicinal products used to treat COVID-19 patients;
- asked the regular manufacturers on the Belgian market to increase production and speed up delivery;
- sought out and found other manufacturers to obtain further deliveries;
- organised a supply of raw materials in order to start up local production in Belgium wherever possible;
- found and purchased stocks in other European countries and around the world;
- also made medicinal products for veterinary use available for human use after verifying full compatibility and safety for said use.
These actions are still ongoing.
Call for medicinal product manufacturers outside Europe
It has become apparent that there is a global shortage of certain medicinal products and that the firms who usually supply these medicinal products to Belgium would not be able to provide enough of them.
For these medicinal products, the FAMHP has had to turn to manufacturers whose medicinal products for human use have not been granted a marketing authorisation (MA) in Belgium.
These products may include medicinal products ordinarily for human use originating from other European or non-European countries, or medicinal products ordinarily for veterinary use.
After a stringent inspection of the quality of the manufacturing site, international laboratory certifications and the strict equivalence of active ingredients and excipients, some of these medicinal products, which are not ordinarily authorised in Belgium, have been deemed equivalent to European standards thereby ensuring that they can be used by patients in Belgium without any additional risk to the patient. A stock was then built up of these medicinal products with guaranteed equivalence.
This information had been shared with hospital pharmacists during daily consultations with the FAMHP without being passed on directly to doctors. This lack of communication has caused concern among doctors, which led Dr Devos, the President of ABSYM/BVAS, to make a statement in recent days. The ABSYM/BVAS and Dr Devos have now been informed of the measures taken and are extremely relieved at the total absence of additional risk incurred by the patient. The ABSYM/BVAS has proposed that, when the next batches of medicinal products arrive, the information on equivalence and identical risk be passed on to the prescribing doctor.
For strictly legal reasons, we are currently requesting that a written declaration be filled in by the doctor using these unauthorised medicinal products, as would be the case under normal circumstances where they were placing the request for such medicinal products to be imported. However, given that the unauthorised medicinal products are being used in such a manner way as the result of a global shortage, the FAMHP has understanding for the fact that the ABSYM/BVAS would like to find a solution not requiring the use of this form. Moreover, the doctors have the impression that this declaration is a transfer of responsibility for the use of these molecules onto their shoulders. A legal analysis is underway at the FAMHP. The ABSYM/BVAS hopes that this analysis will find a solution that negates the need to use this legal form (Article 105 of the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use).
Stocks of medicinal products to last several weeks
With regards to temporary disruptions to the deliveries of medicinal products to hospitals, some difficulties were encountered at the beginning of the pandemic with the organisation and the fair distribution of strategic stocks between hospital pharmacies, due in part to the limited stocks available.
Currently, a continuous flow of deliveries and a decrease in critical orders of medicinal products has been achieved thanks to the efficient work of the FAMHP, the increased number of stocks available, the closer collaboration of the FAMHP with pharmaceutical companies, the updating of the distribution keys by the FPS Public Health and stronger measures taken by the General Administrator of the FAMHP. The system currently in place will therefore be maintained or even improved if necessary, depending on feedback received from healthcare professionals in the field.
The FAMHP has also informed the ABSYM/BVAS that the current stock of available medicinal products is sufficient to treat patients for more than 4 weeks and that obtaining deliveries now seems to be less complicated than during the previous 15 days. The FAMHP now aims to ensure a stock of more than 6 weeks of use.
The ABSYM/BVAS understands that, alongside medicinal products authorised in Belgium, the use of medicinal products not authorised in Belgium is necessary under these extraordinary circumstances to respond to international drug shortages.
The ABSYM/BVAS is reassured as to the methodology used by the FAMHP to guarantee that these medicinal products (not covered by an MA) are equivalent to those medicinal products that are ordinarily authorised (Marketing Authorisation). They insist that prescribing doctors be kept up to date on this matter and on the exemption from the associated use of the aforementioned legal form.
The ABSYM/BVAS and the FAMHP will remain in contact to ensure that any difficulties on the ground are reported as quickly as possible.
The FAMHP and the ABSYM/BVAS both wish to continue to offer the best possible care to the greatest possible number of patients despite the difficulties encountered during a pandemic. This meeting was thus productive in addressing all of the doctors' concerns.
For the ABSYM/BVAS, For the FAMHP,
Dr Ph DEVOS Xavier De Cuyper