After several months of investigation and an extensive public consultation regarding the health sector, the French Competition Authority (hereinafter “the FCA”) has finally issued its opinion on April 4.
Since November 2017, the FCA has led a wide investigation regarding the sectors of drug distribution and medical biology. Indeed, according to the FCA, these sectors are particularly important in the French economy and are rapidly evolving due notably to the development of telemedicine, driven by digital technologies and artificial intelligence, the development of online sale of medicine, under the impetus of the European Union, the restructuring of medical biology, etc.
In its opinion, the FCA recommends some amendments in the current French regulation governing the healthcare sector and, in particular, the following:
The FCA notes that even though online sales of medicine with optional prescription have been authorized in France since 2012, its very restrictive framework prevents pharmacies (only ones allowed to open such website) from developing and competing against their European peers. Thus, the FCA suggests softening the constraints on online sales of medicine to allow websites based in France to compete with European websites on an equal level by:
– authorizing pharmacies to use storage facilities located further away if necessary, in order for them to efficiently develop their activity;
– authorizing pharmacies to group their online sales in a common website, which will allow an easier access to their activity and efficiency gains;
– reviewing the obligation to recruit assistant pharmacists so that it is based solely on medicine sales made by the pharmacy, excluding the sales of parapharmacy, hygiene and cosmetics products.
The FCA has also identified blockages that limit the effective development of the new missions that have been entrusted to pharmacists by the public authorities. The FCA therefore encourages the public authorities to lift these blockages and encourages a broader reflection on the development of new complementary missions:
– Complete the framework of new missions, such as vaccination, to ensure their effective development by removing the identified obstacles
– Invite public authorities to consider the extension of new missions that could for example include:
o The screening of non-transmissible or infectious diseases
o The supervised distribution of certain prescription drugs for benign pathologies, in emergency or preventive situations not requiring a medical diagnosis, etc.
Regarding the rules on advertising of prescription drugs and medicine with optional prescription, the FCA considers they respond to clear justifications and should therefore remain unchanged.
However, the FCA raises the fact that, without any public health reason justifying such limitations, the rules governing the advertising that pharmacies can carry out are much more restrictive than those imposed on their competitors, such as supermarkets, regarding the sale of parapharmacy products.
Thus, whilst inviting to maintain the principle of strict supervision of medicine advertising, the FCA also makes several proposals for the revision of the rules applicable to advertising issued by pharmacies and in particular, for the revision of the pharmacists’ code of ethics, with a twofold objective:
– make advertising more flexible for products other than medicine;
– make advertising rules for pharmacies more flexible to enable pharmacists to better promote;
– the services offered to patients.
Furthermore, the development of pharmacies and the new missions entrusted to pharmacists require access to new sources of funding. Consequently, following the example of other European countries, the FCA believes that France could explore the possibility of a supervised opening of the capital of pharmacies, while guaranteeing strict respect for the professional independence of pharmacists. To do so, the FCA identifies multiple scenarios for the evolution of the legislation (from the increase in the number of minority shareholdings of pharmacists to the opening to external investors).
Regarding the monopoly held by pharmacies on the sale of medicines and certain category of products (e.g. medicinal plants), if the FCA doesn’t call it into question, it suggests a limited and highly supervised diversification of distribution points in order to improve accessibility of such products and provide a greater price competition. This diversification would complete the officinal network without replacing it.
Such flexibility would not apply to prescription drugs but only to the following products:
– medicines with optional medical prescription (treatment of sore throats, colds, etc.);
– in vitro diagnostic medical devices (HIV screening self-tests, blood glucose meters, etc.);
– certain medicinal plants (listed in the pharmacopoeia);
– certain essential oils previously reserved for sale in pharmacies.
The distribution of these medicines and products would necessarily be under the responsibility of a qualified pharmacist, in charge of supplying medicines and advice throughout the time of sale (based on the reforms introduced in Italy and Portugal).
These products could only be sold in a dedicated area with a separate cash register.
Additional requirements could be expected, such as the prohibition of sales objectives or the implementation of a co-responsibility mechanism for the company manager and the salaried pharmacist.
Regarding the intermediaries of the drug distribution system (wholesaler-distributors), the commercial conditions obtained by them from laboratories are often less advantageous than those obtained by pharmacies.
On that matter, following the examples of the Cour des Comptes (General Accounting Court) and the Inspection Générale des Affaires Sociales (General Inspectorate of Social Affairs), the FCA invites public authorities to review the overall model of wholesaler-distributors, and in particular their compensation conditions, currently based solely on the price of medicines, in order to proportion them to their public service obligations, which aim to ensure a continuous and homogeneous supply of medicines in the territory. A remuneration based on the volumes distributed could thus be considered.
As for the private medical biology sector (laboratories), the FCA is favorable to a review of the conditions under which the capital of laboratories is held, in order to enable all actors in the sector to benefit from the same external growth opportunities.