A draft bill amending the medicines act (GMW) due to technical improvements and the raising of the maximum penalty

13 april 2017 – Silvie Wertwijn

On 16 March 2017, the draft bill amending the Dutch Medicines Act (Geneesmiddelenwet) due to technical improvements and the raising of the maximum penalty was submitted to the Lower House of the Dutch Parliament (Tweede Kamer).

The draft bill raises the maximum legal level of the administrative penalty for violations of the Medicines Act from Euro 450.000,= to no less than EUR 820.000,=.

The intended raise is based on a motion from the MP’s Bruins Slot and Van Gerven requesting a substantial raise of the administrative penalty if a pharmaceutical company allows a medicine shortage to arise, or fails to announce this in a timely manner. This is also the sole reason mentioned in the explanatory notes to the draft bill for this substantial increase of the legal maximum penalty of the Medicines Act as a whole.

That is why the Consultancy section of the Dutch Council of State (Raad van State) was critical about the absence of a substantive motivation for the proposed general increase of the legal maximum penalty. In turn, the legislator argues that in tabling the motion, the authors of the motion did indeed intend to raise the standard amount of the penalty for the entire Medicines Act to EUR 820.000,=, in accordance with the Dutch Commodities Act[1](Warenwet). Thus, this motion would therefore be well-suited to the intention of giving the penalty a larger role, given the financial advantages that can be achieved by pharmaceutical companies.

In addition, a couple of technical improvements to the Medicines Act (Act) are being proposed, as well as a few more substantial additions and amendments. Thus, in article 18 paragraph 6 of the Act, an expansion is being realized of those activities of the manufacturer , wholesaler and pharmacist that can take place under an exemption from the National Health Inspectorate (IGZ) by bringing the goods into Dutch territory in ways other than through import. The banned activities as identified in article 40 paragraph 1 and 2 of the Act concerning the introduction of medicines without marketing authorization is expanded with the putting up for sale (e.g. using the internet) and by exporting. In addition, the compassionate use procedure and the use in dire cases as meant in article 83 EU Directive 726 is further clarified in article 40 paragraph 3(f) of the Act. In the prohibition clause regarding UR- and UA-medicines of article 61 paragraph 1 of the Act, the isolated act ‘selling’ is also being included in the prohibition. This with a view to internet selling. The same change is being proposed for the articles 62 (prohibiting of personal delivery of UAD-medicines by a pharmacist or chemist) and 67a (prohibiting selling through the internet).

Another aspect is a change to article 83 of the Act, in which the range of the advertising guidelines and the delimitation between information and advertising is being determined. Chapter 9 of the Act – next to, for instance, the leaflet with and the labelling of a medicine – does not apply to medicines used for research purposes, not being medicines for which a marketing authorization has been given and are being used as comparative data in a medical scientific research involving people. It is being proposed to delete the terminology as comparative data (sub a). Another exception applies to the so-called information on request. Within that framework, sub c is rendered as follows: a letter or email message, whether or not accompanied by documentation with no advertising purposes being intended, in order to grant a specific request for information on a particular medicine.

The measures the Health Inspectorate can take to avoid any harm to public health is being expanded with the authority in specific cases of being able to confiscate medications or active ingredients (article 115 paragraph 1 of the Act) directly on the spot. In addition, paragraph 2 of that article explains that the Health Inspectorate can order the removal from the market of medicines or the suspension or termination of their delivery, after which the person possessing the medicine is obliged to implement the order.

The proposed draft bill will now first be discussed in the Lower House (Tweede Kamer). Once it has been passed – possibly after being amended – it will be sent to the Upper House (Eerste Kamer). So, it will take some time before the amended Medicines Act will come into force.

[1] In accordance with the sixth category of article 23 of the Penal Code, thus at present EUR 820.000,=.

Silvie Wertwijn