Publicaties & Noten  

A. Kooy, Wijziging Geneesmiddelenwet op komst, LS&R 763.
Een redactionele bijdrage van Annemieke Kooy, Axon Advocaten.
De Europese richtlijn betreffende vervalste geneesmiddelen wordt geïmplementeerd: meer regels, vaker registraties nodig. Voor wat en voor wie?
Inleiding: De distributie van geneesmiddelen in Europa gaat volgens een gesloten systeem, zodat er een legale distributieketen is. Pas als vergunningen zijn verleend, mogen geneesmiddelen in het verkeer worden gebracht. De Nederlandse Geneesmiddelen wet zal worden gewijzigd ter implementatie van richtlijn 2011/62/EU (“Richtlijn”), die beoogt te verhinderen dat vervalste geneesmiddelen in de legale distributieketen belanden.

Wijziging Nederlandse Geneesmiddelen wet
In de gewijzigde situatie is zal sprake zijn van een uitbreiding wat betreft producten en wat betreft actoren. Als producten zullen niet alleen geneesmiddelen van belang zijn, maar ook werkzame stoffen. Nieuwe actoren zijn bemiddelaars in geneesmiddelen en groothandelaars en fabrikanten van werkzame stoffen (voorheen waren dit alleen groothandelaars en fabrikanten van geneesmiddelen). Deze moeten nu allen voorafgaand aan de productie/verhandeling van een geneesmiddel geregistreerd worden door CIBG (Farmatec).

Lees de gehele bijdrage hier.

Annemieke Kooy, Axon Advocaten

K.E. Verzijden, The Role of Razzies in EU Food Law, LSenR.nl LS&R 752
Bijdragen ingezonden door Karin Verzijden, Axon advocaten.
This article is a short extract of a publication in EFFL 2013/6, which provides a broader perspective in the framework of misleading advertising, both in the Netherlands and Germany.

Golden Raspberries
One day before the distribution of the Academy Awards for excellence of cinematic achievements, the ceremony of Golden Raspberries or “Razzies” takes place. Razzies are awarded in recognition of the worst in film. Obviously, no producer, actor or actress is looking forward to receiving this “prize”. However, Razzy ceremonies continue to take place ever since 1980, so there seems to be no escape.

Public perception
One can wonder if the yearly Razzies constitute an isolated momentum or if they have some social or economic impact indeed. Based on the changes applied in the information provided currently provided with the Natrena Stevia product, this latest Razzy seem to have had repercussions indeed. Douwe Egberts added an explanatory note on its website regarding the limited quantity of Stevia contained in its product Natrena Stevia crystal powder. In free English translation this reeds "Stevia crystal powder consist of the light filler maltodextrine (97%) and Stevia (steviol glycosides 3 %). Why so little Stevia? That is because Stevia is 300 times sweeter than sugar and in its pure form therefore is difficult to dose. The filler causes 1 small spoon of Natrena Stevia to be as sweet as a small spoon of sugar, but it contains far less calories (3kcal per tea spoon)." Based on all of this, it can be concluded that public perception, in addition to all legal and other product requirements, also plays a role in EU Food Law. Hopefully for the benefit of our healthy appetite!

Karin Verzijden

E. Gielen en B. Essink, The tricky business of drug/device classification in the EU.

Zie ook LSenR 717. Een redactionele bijdrage van Ellen Gielen en Bart Essink, CMS Derks Star Busmann.
Introduction
On 3 October, the Court of Justice of the EU published its long-awaited ruling in the Laboratories Lyocentre case in relation to the classification of medical products1,2. The CJEU ruled that a product can be classified as a medicinal product in one EU member state and as a medical device in another. The case is significant for manufacturers of medical devices and medicinal products although it does not provide further guidance on those products belonging to the “grey area” between medical devices and medicinal products. It confirms previous rulings of the CJEU that products can be classified differently in different member states. The judgment of the CJEU goes against efforts to harmonize regulation of the EU market. Based upon prior judgments with respect to the classification of products, the decision was not a big surprise. Nonetheless, it shows that the EU harmonization procedure is far from finished. In fact, EU regulation of the free circulation of goods has emerged from and been strengthened by the judgments of the CJEU3. However, the process of creating common standards across the EU market with respect to the classification of medical products should now be a priority. In the current legislative climate, the CJEU is notable to play a critical role on this front, and politicians should step in with further regulation from Brussels.

 

(dit artikel is ingekort, lees het gehele artikel hier)

Concluding remarks
The importance of greater clarity across the single market as to the rules governing the classification of products is obvious, especially in relation to the decision of manufacturers in the development, marketing and potential liability of new products. The CJEU’s decision confirms that member states must make classification decisions on a case-by-case basis. It recognizes that there is incomplete harmonization in the EU and, as such, there is a risk that member states may adopt different views leading to inconsistent positions in each jurisdiction. It is clear that the directives in place cannot provide a satisfying solution, and it is increasingly likely that further legislation will be needed to achieve market harmonization for medical products across the EU. The views expressed in this article are for general informational purposes and guidance only and do not purport to constitute legal or professional advice. All information relates to circumstances prevailing at the date of publication.

Ellen Gielen en Bart Essink

W. Pors, B. Vandermeulen, Bird & Bird submission on the Rules of Procedure for the Unified Patent Court, brief 30 september 2013.
Ingezonden door Wouter Pors, Bird & Bird gericht aan het Prepatory Committee van het Unified Patent Court: On behalf of Bird & Bird LLP we hereby submit our comments on the Draft Rules of Procedure for the Unified Patent Court as published on the website on 31 May 2013. This submission was prepared by the International UPC Steering Group of Bird & Bird, which comprises patent litigators and patent attorneysin the various countries in which we practise. We have also been involved in the preparation of the submissions of AIPPI and EPLAW and have taken these submissions into account. We have further also taken the epi submission into account. This submission represents our independent professional view of the Rules of Procedure and is made to support the further improvement of the envisaged system.

We have taken the UPC Agreement as a given starting point that currently cannot be changed any more, which does not mean that we support all choices made in that Agreement. However, in some instances we cannot avoid suggesting some small amendments to the Agreement, but only where we think such amendments do not touch on political issues.

Lees de gehele bijdrage hier.

Een bijdrage van Karin Verzijden, Axon
How to advertise healthy berries without cherry picking?
How do you communicate the main characteristics of your product to the public [red. zie ook: LS&R 704]? First of all by its name of course – fair enough. At second glance, the list of ingredients comes into play. Pretty simple, isn’it? Beware however that Regulation 1169/2011 on the provision of food information to consumers (“the Regulation”) provides detailed rules for these two items – and more. And that you need to act in compliance by 13 December 2014, both regarding your product labels and regarding the information provided on your company’s website. If you are of the opinion that you can use a little help from this perspective, this post may be useful to you.

Name of the food
If there is a name prescribed by law for a food product, this must be used, e.g. “herring”. In the absence of such legal name, the customary or a descriptive name shall be used. This is a description of the food, and if necessary of its use, which is sufficiently clear to enable consumers to know its true nature and distinguish it from other products with which it might be confused, e.g. “cookie with Brazil nuts”.

Name in Member State of production equals name in Member State of marketing
In general, the name of the food in the Member State of production will be the same as the name in the Member State where the food is marketed, unless such does not enable the consumer to know the true nature of the food. For example, the name “vegetable samosa” may need to be qualified by “a pastry parcel with spicy vegetable filling”.

Other particulars to be communicated
Furthermore, the name of the food shall include or be accompanied by the particulars as to the physical condition of the food or the specific treatment which it has undergone in all cases where omission of such information could mislead the consumer, e.g. “freeze-dried” or “quick-frozen”. Also, in the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted, the labeling shall bear a clear indication of the component/ingredient that has been used for the partial of whole substitution. This should be done in close proximity to the name of the product and in a font size that is not much smaller than the name of the product. Finally, meat and fishery products giving the impression to be made of a whole piece of meat or fish, but actually consist of different pieces combined with other ingredients, shall bear the indication “formed meat/fish”. Bon appetit!

List of ingredients and legibility requirements
The list of ingredient shall include all ingredients of the food, named by their specific name, in descending order of weight, as recorded at the time of their use in the manufacture of the food. Only ingredients constituting less than 2 % of the finished product may be listed in a different order after the other ingredients. Futhermore, ingredients which belong to certain categories, e.g. “mixtures of flour obtained from two or more cereal species”, may be designated by the name of that category rather than by the specific name. As far as information present on the product label is concerned, this shall be printed on the package or on the label in such a way as to ensure clear legibility. Therefore, the x-height of het characters used shall in principle be equal to or greater than 1,2 mm.

Both product label and website information should be complete
Even if your product labels comply with all of the above, you may still be subject to a complaint regarding misleading information if your website information is not complete. In a recent decision of the Dutch Advertising Code Committee, a complaint regarding the product “Healthy People’s blueberry and raspberry juice” was discussed. According to this complaint, both the packaging and the company website provided misleading information regarding this product. The claim regarding the packaging was aimed at the fact that it only displayed blueberries and raspberries, whereas in reality, the juice consisted of 10 % blueberry and 4 % raspberry. From the list of ingredients, it appeared that other ingredients were apple, white raisin and aronia. The claim regarding the website was directed against the fact that blueberry and raspberry were the only ingredients mentioned.

Characteristic taste of the product
As a defence, Healthy People argued regarding both the packaging and its website that it was a deliberate choice to insist on the characteristic taste of the product rather than on side-issues.  Besides, the consumer was considered smart enough to understand that a juice consisting of only blueberries and raspberries would be too sour and too expensive (the average price of a liter blueberries being EUR 15). Healthy People so far had not received any consumer complaints and it therefore had not realised there was some issue here.

Average consumer
The Advertising Code Committee considered that the packaging was in line with applicable legislation. Allegedly, the average consumer would understand that the product does not only consist of blueberries and raspberries. Instead, such consumer understands that these ingredients are, amongst others, part of the product. Such could be deduced from the list of ingredients that the average consumer can be expected to consult regarding a high end fruit drink. Now that the website did not contain such list of ingredients, this was considered unclear. In the absence of full information a consumer could decide to buy this product, whereas he would not have done so otherwise. The limited information provided on the website was therefore considered misleading.

Conclusions
As follows from the decision discussed above, it is not sufficient that the labeling is in compliance with the applicable food information legislation, the same applies to the information provided at your company’s website. As of December 2014, many detailed food information rules will apply under the Regulation. However, despite the aim for harmonization at an EU level, there is still room for interpretation. This for instance applies to name of the product in connection with the wording “where omission of such information could mislead the consumer”. It does not come as a surprise that the interpretation of such wording may vary from country to country. Obtaining local advice for the launch of a new product therefore continues to be a sound plan. Also, do not overlook the annexes attached to the Regulation. They are 15 and full of strict requirements, for instance the one to state “formed meat” on your product. Although not so sexy, when applicable, you will not be able to get around it!

Karin Verzijden

P. van Gemert en W. Pors, The effect of an opt out under Article 83 of the agreement on a Unified Patent Court on Jurisdiction for decisions on the merits and preliminary injunctions
Een bijdrage van Peter van Gemert en Wouter Pors, Bird & Bird.

1. The Unified Patent Court and the issue of Article 83
Since the Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012, implementing enhanced cooperation in the area of the creation of unitary patent protection (Unitary Patent Regulation) and the Council Regulation (EU) No 1260/2012 of 17 December 2012, implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation ar-rangements (Regulation on Translation Arrangements) have been adopted in December 2012 and following that the Agreement on a Unified Patent Court (UPC Agreement) was signed on 19 February 2013, the creation of a Unitary Patent and of a Unified Patent Court to enforce it seem to be making steady progress towards implementation, which is expected early 2015. As of then, Unitary Patents, with effect in all Member States partici-pating in the enhanced cooperation can be obtained and the first action can then be launched in the Unified Patent Court.

It is clear that the Unified Patent Court will have exclusive jurisdiction for the infringe-ment and validity of Unitary Patents right from the start, without any exception. In addi-tion to that, the Court is also intended to have exclusive jurisdiction for traditional Euro-pean patents, which will remain a permanent alternative for the Unitary Patent. Howev-er, giving unconditional exclusive jurisdiction for those patents to a court that does not exist yet and that will apply rules that are not yet completely known was one step too far. Therefore, the UPC Agreement contains a transitional regime which will initially apply for a period of at least 7 years, but may even be prolonged.

(...)

2. The effect of an opt out on actions on the merits

Basically there are two possible interpretations. First, the phrase “opt out from the exclu-sive competence” may simply have been worded that way because Article 32 contains the phrase that “the Court shall have exclusive competence in respect of” and may thus have been intended as a simple reference to the competence of the Court in general, which happens to include the word “exclusive” in Article 32. This interpretation would indeed mean that an opt out for a given traditional European patent fully blocks out the Unified Patent Court’s competence with regard to that patent.

3. Preliminary injunctions

(...)

The issue gets even more complicated in case of a preliminary injunction. Article 24(1)a UPCA provides that Union law takes priority over the UPC Agreement and Article 31 UP-CA provides that jurisdiction shall be established in accordance with the Brussels I Regu-lation. Also, in view of the light of Article 5 Unitary Patent Regulation and its history, it is quite clear that both the European Union and the contracting Member States of the en-hanced cooperation agreed that Union law should have priority. Now, Article 35 of the Brussels I Regulation (recast) provides that “application may be made to the courts of a Member State for such provisional, including protective, measures as may be available under the law of that Member State, even if the courts of another Member State have jurisdiction as to the substance of the matter”. Under Consideration 11 of the Brussels I Regulation (recast) and certainly under the proposed Brussels I Amendment it is clear the Unified Patent Court is a court as meant in Article 35.

Digitaal versus papier, Advocatenblad september 2013

'Zoekt de advocaat digitaal of op papier? Die vraag houdt de markt van juridische vakinformatie in zijn greep.'

'Bij kantoorbezoeken viel het de Haagse deken Bas Martens zo op dat advocatenkantoren bezuinigen op papieren bronnen, dat hij het hoog tijd vond de sector een signaal te geven. (...) Dat kwam hem op een stevige reactie te staan van advocaat Wouter Pors (Bird & Bird).' Zie IEF 12647 en IEF 12640.

'Deze intellectueel-eigendomspecialist stelt op de website IE-Forum.nl dat 'tegenwoordig  van een advocaat verlangd kan worden dat hij tijdens een zitting kan reageren op stellingen van de wederpartij, ook met behulp van online toegang tot zijn knowhow. Een papieren bibliotheek biedt die mogelijkheid niet en voldoet dus niet meer.''

Lees hier meer.

P. van Gemert en W. Pors, The effect of an opt out under Article 83 of the agreement on a Unified Patent Court on Jurisdiction for decisions on the merits and preliminary injunctions
Een bijdrage van Peter van Gemert en Wouter Pors, Bird & Bird.

1. The Unified Patent Court and the issue of Article 83
Since the Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012, implementing enhanced cooperation in the area of the creation of unitary patent protection (Unitary Patent Regulation) and the Council Regulation (EU) No 1260/2012 of 17 December 2012, implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation ar-rangements (Regulation on Translation Arrangements) have been adopted in December 2012 and following that the Agreement on a Unified Patent Court (UPC Agreement) was signed on 19 February 2013, the creation of a Unitary Patent and of a Unified Patent Court to enforce it seem to be making steady progress towards implementation, which is expected early 2015. As of then, Unitary Patents, with effect in all Member States partici-pating in the enhanced cooperation can be obtained and the first action can then be launched in the Unified Patent Court.

It is clear that the Unified Patent Court will have exclusive jurisdiction for the infringe-ment and validity of Unitary Patents right from the start, without any exception. In addi-tion to that, the Court is also intended to have exclusive jurisdiction for traditional Euro-pean patents, which will remain a permanent alternative for the Unitary Patent. Howev-er, giving unconditional exclusive jurisdiction for those patents to a court that does not exist yet and that will apply rules that are not yet completely known was one step too far. Therefore, the UPC Agreement contains a transitional regime which will initially apply for a period of at least 7 years, but may even be prolonged.

(...)

2. The effect of an opt out on actions on the merits

Basically there are two possible interpretations. First, the phrase “opt out from the exclu-sive competence” may simply have been worded that way because Article 32 contains the phrase that “the Court shall have exclusive competence in respect of” and may thus have been intended as a simple reference to the competence of the Court in general, which happens to include the word “exclusive” in Article 32. This interpretation would indeed mean that an opt out for a given traditional European patent fully blocks out the Unified Patent Court’s competence with regard to that patent.

3. Preliminary injunctions

(...)

The issue gets even more complicated in case of a preliminary injunction. Article 24(1)a UPCA provides that Union law takes priority over the UPC Agreement and Article 31 UP-CA provides that jurisdiction shall be established in accordance with the Brussels I Regu-lation. Also, in view of the light of Article 5 Unitary Patent Regulation and its history, it is quite clear that both the European Union and the contracting Member States of the en-hanced cooperation agreed that Union law should have priority. Now, Article 35 of the Brussels I Regulation (recast) provides that “application may be made to the courts of a Member State for such provisional, including protective, measures as may be available under the law of that Member State, even if the courts of another Member State have jurisdiction as to the substance of the matter”. Under Consideration 11 of the Brussels I Regulation (recast) and certainly under the proposed Brussels I Amendment it is clear the Unified Patent Court is a court as meant in Article 35.

Brief van de Gezondheidsraad aan de Tweede Kamer 19 augustus 2013, 'Advies over mobiele telefoons en kanker'
Conclusies Gezondheidsraad - De Gezondheidsraad komt, op basis van de epidemiologische gegevens die in zijn advies zijn beschreven en daarbij de kwaliteit en de sterke en zwakke punten van de verschillende onderzoeken in aanmerking nemend, tot de volgende eindconclusie: “Er is geen duidelijk en consistent bewijs voor een verhoogd risico voor tumoren in de hersenen of andere delen van het hoofd gerelateerd aan gebruik van een mobiele telefoon gedurende 13 jaar of minder; een dergelijk risico kan echter ook niet worden uitgesloten. Over langduriger gebruik kan niets worden gezegd.”

Rapport 03/06/2013 - Mobile phones and cancer

Lees verder

Uit het persbericht: De Nederlandse Voedsel- en Warenautoriteit (NVWA) waarschuwt consumenten voor afslankpillen met de naam Dexaprine en adviseert hen direct met het middel te stoppen. Dexaprine is een product dat wordt gebruikt door sporters en mensen die willen afvallen. Het wordt in Nederland via webshops verkocht.

Lees verder