Newsletter Life Sciences & Healthcare

Newsletter 1/2017
Life Sciences and Healthcare

1. Branded vs. generic prescription

In Norway today almost all medicines are prescribed after the brand name, not the active substance, ergo by branded prescription. The Norwegian Medicine Agency (NOMA) has on an assignment from the Ministry of Health and Care Services (MHC) recently considered a transition from branded prescribing to prescribing by the active substance, - so called generic prescribing.

NOMA delivered its report in December 2016. In the report NOMA recommends a transition and emphasize that it is practical that medicine are prescribed after the active substance as this would contribute to more secure communication between health care professionals and between health care professionals and patients.

Current regulations open for a generic prescription, but the opportunity is rarely used. In the pharmacies the patients are therefore often offered another brand than the one indicated on the prescription. NOMA believes that this creates uncertainty amongst patients and larger risk of errors. The arrangement also adds to the obligations of the pharmacy staff. This could be avoided if the doctor only indicates the applicable active substance on the prescription. The active substance will also be known across national borders. Accordingly, NOMA's recommendation for a transmission is first and foremost motivated by the consideration of patient security. No economical profit of significance is expected as today's in-pharmacy-swap-arrangement in fact already directs for the most reasonable medicine to be handed out.  However, NOMA emphasize that a transmission also will, in addition to making it easier for doctors to prescribe (they will not have to remember product names and prescriptions can be renewed without change even if unit packs are deregistered), lessen the pharmaceutical industry's prospect to influence doctors prescriptions. NOMA assumes that today's brand name advertisement will give less effect.

NOMA realises that mandatory generic prescription cannot apply in all events. A two-track system is necessary to handle situations where medical or technical reasons require branded prescriptions or if the doctor has reserved against an in pharmacy-switch.  NOMA therefore suggests a so called "exemption list" is to be established.

The MHC has taken the matter up for further evaluation. What is clear is that a potential transmission to mandatory generic prescription would necessitate considerable changes of today's practice, the doctors' journal systems, as well as the legal framework. The MHC has been reluctant to provide information on if, when and in what way a transmission can be expected. The MHC has however referred to NOMA's report in which a 5 year step by step transmission is suggested.

2. The peadiatric regulation will be implemented in Norwegian law as from 1 September 2017. The pharmaceutical industry can apply for a patent extension from 1 August.

The Pediatric Regulation (no. 1901/2006) is a separate regulation on medicines for children. The Regulation was adopted by the EU already in 2006. The regulation is now being implemented in Norwegian law.

The purpose of the new regulation is to ensure better documentation of safety and efficacy, as well as to increase the availability, of drugs specifically intended for children. While it has not been studied on children earlier, it has now been recognized that children may have a different effect of drugs than adults. In the medical sense, children are not young adults, and it is not always a matter of dose adjustment to adapt new drug regimes.

To encourage studies on drugs intended for children, an incentive is provided. According to Regulation 469/2009/EC (the SPC Regulation), once an EMA-approved plan for testing the drug for use on children has been completed (Pediatric Investigation Plan (PIP), this provides for a six-month extension of the Supplementary Protection Certificate (SPC) for the medicinal product. In reality, this implies an extension of the patent protection.

Application for extended protection may be submitted for the first time on 1 August 2017.

The rule further requires that ESA be given the authority to impose fines on drug companies in case of breach of the provisions.

The new legislation is planned to enter into force in Norway on 1 September 2017.With this, the pharmaceutical industry in Norway gets the same framework conditions as the EU countries.

Both regulations provide for transitional arrangements for SPCs that have already expired or will expire before Pediatric Regulation enters into force, including an opportunity to apply for an extension if the SPC has expired less than 6 months prior to the enforcement. Suppliers that hold SPCs for medicinal products in Norway or who are planning to launch new generic drugs in Norway should review the transitional arrangement closely to ensure their positions.

3. Medical Devices – The supervision of medical equipment will be transferred to the Norwegian Medicines Agency

The Norwegian Directorate of Health is currently a professional and supervisory authority for medical equipment in Norway and supervises products, manufacturers and other traders, as well as technical control bodies.

The Ministry of Health and Care Services has decided that the Directorate of Health's management tasks related to the medical equipment area shall be transferred to the Norwegian Medicines Agency (NOMA), - likely witheffect from 1 January 2018.

The transfer to NOMA is to be seen in connection with the introduction of new regulations for medical devices, adopted by the European Parliament on 5 April 2017.

With this, the industry in Norway will have the same supervisory agency as in Denmark, Sweden and most of the other EU countries.

4. New maximum and minimum limits for Food Supplements

There are no harmonized rules on maximum and minimum levels of vitamins and minerals in food supplement at the EU/EEA level. Pending such harmonized levels, each EU/EEA Member State practice sets their own levels, however, the general EU/EEA principles shall apply and thus ensure the functioning if the internal market, cf. e.g.  Directive 2002/46/EC article 11, 2nd paragraph.

The Norwegian Authorities have generally been very restrictive both with regards to fortification of food as well as the levels of the approved max. and min. levels of vitamins and minerals in the Food Supplement Regulation. The Norwegian levels were set on the basis of rather old scientific data, and in practice, the levels implied barrier to trade and an impediment to the internal market. It was first when the EFTA Surveillance Authority questioned the legality of the Norwegian practice in light of the principle of mutual recognition, that the Norwegian regime has been changed. 

With effect from 30th May 2017, the Regulation on Food Supplement has undergone a dramatic change paving the way for food supplements available also in other EU/EEA Member States. Now, there are only a few vitamins and minerals that have a maximum and minimum vitamin levels set for adults, but recommended dosages are set new for young children (1-3 years), children (3-11) and older children (11-18).  With the exemption of e.g. vitamin D and folic acid, no maximum limits are set for adults, allowing  larger flexibility for the industry to offer a range of food supplements to the extent the safety standards are met. 

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 © 2017 KVALE Advokatfirma DA