Publicaties & Noten  

Een bijdrage van John Allen, uit de nieuwsbrief Nauta Dutilh N.V..

The Court of Appeals of The Hague has recently ruled that healthcare insurance companies, by inviting parties to bid in a tender to become the preferred supplier of a medicinal product which is still under patent (SPC) protection, do not infringe the originator's patent and do not commit an "unlawful act" (i.e. a tort). That is, provided certain strict conditions are observed [red. LSenR 253].

Facts of the case
Pfizer was the holder of a now expired SPC for the compound latanoprost, sold under the name Xalatan. At the time, Xalatan was sold by Pfizer as well as by six parallel importers. In addition, several generic competitors held marketing authorisations for latanoprost.

Within the framework of their "preference policy", healthcare insurers UVIT and VGZ organised a sealed-bid tender to appoint the preferred supplier of latanoprost. This means that clients of the insurers only receive reimbursement if they obtain the product of the preferred supplier.

In mid 2011, UVIT and VGZ invited Pfizer, the parallel importers and the generic competitors to bid in the tender. Pfizer's SPC was in force until 17 January 2012, and the suppliers were asked to submit their offer before September 2011. After Pfizer objected, the insurers moved the deadline for submissions in the tender to 25 January 2012.

Pfizer's arguments
Pfizer argued that the tender would lead to an agreement between the insurers and the generic manufacturers which would result in a commitment to supply latanoprost to pharmacies and that by doing so before the SPC expired, they would necessarily infringe Pfizer's rights. According to Pfizer, by organising the tender the insurers were "otherwise trading in" the substance protected by the SPC, within the meaning of article 53 of the Dutch Patents Act 1995 ("DPA").
In the alternative, Pfizer alleged that the tender procedure amounted to an unlawful aiding or facilitating of patent infringement. The parties agreed, in line with current case law, that there would be an infringement by a generic competitor (as opposed to the insurer) if the former made an offer during the period in which the SPC was still in force, even where the offer specified that the protected substance would only be delivered after the SPC expired.

Decision
The Court considered the legislative history of article 53, and acknowledged that "otherwise trading in" should be interpreted broadly. However, it found that this concept in any event required that the product actually be made available to a third party. Since the insurers did not make the product available to a third party, they did not "otherwise trade in" the patented products and therefore did not infringe the SPC.

The Court held that the insurers would only have committed an act of tort if they had provoked or incited the generic competitors to commit an infringement. That was not the case here as it concerned a general invitation, addressed to all known suppliers, including the patent owner as well as the parallel importers of the medicine. This means that several of the parties invited to participate in the tender could supply the product without committing patent infringement. The court furthermore attached importance to the fact that in the invitation, the insurers indicated that they would respect third parties' patent rights and that the tendering parties would be obliged to do the same. Under such circumstances, the invitation did not provoke or incite generic manufacturers to commit a patent infringement. This was especially true because the parties could place their bid after the SPC had expired.

Conclusion
The Court of Appeal's decision attached considerable weight to the fact that the tender was open to multiple 'non-infringing' parties and that the deadline was extended until after SPC expiry.

It can be inferred from the decision that the Court of Appeal is prepared to intervene in tender procedures conducted by insurance companies where generic competitors are invited to compete whilst there is still a valid patent or SPC.
This decision is in line with the recent Supreme Court decision in Pharmachemie/Glaxo (2012), in which it was held that entering a generic pharmaceutical in the national pharmacy database, even with the explicit proviso that products will not be delivered until after patent expiry, constitutes an infringing offer under the DPA.

Also notable in this series of decisions exploring the boundaries of what conduct constitutes an infringement or tort is the preliminary finding that tacitly approving and/or facilitating a foreign patent infringement may constitute a tort under Dutch law (see our recent newsletter on the Boehringer Ingelheim/Teva case).

K. Verzijden, How easily digestible wine and healthy chocolate tempt to seduce - recent decisions on Health Claims, LifeSciencesenRecht.nl, LSenR 276.

Commentaar in't kort van Karin Verzijden, Axon advocaten.

By 14 December 2012, food items in the European Union (EU) with a health claim on their packaging not on a permitted list will have to be removed from the shelves. The so-called permitted claims list was developed on the basis of the Regulation on nutrition and health claims on foods (the Regulation) , which came into force in January 2007. The aim of this Regulation is to harmonise rules related to health claims on food, in order to allow the consumer to make an informed choice and to stimulate the free movement of foods. All nutritional and health claims made in commercial communication in relation to all foodstuffs, including drinks and supplements fall within its scope. With this Regulation, the Commission hopes to eliminate misleading claims and to allow only those that are clear, easily understood by consumers and supported by scientific evidence, while at the same time levelling the playing field for food product manufacturers in the EU.

(...)

Recent cases: EU
Despite criticism and pending annulment action, at the moment the health claims Regulation is being enforced and strictly interpreted. A prime example is the recent case at the European Court decided on 6 September 2012, in which the Court upheld the prohibition on the marketing of wine as ‘easily digestible ’. Even though the statement was correct in principle and did not imply an improvement in health, it implied the preservation of a good state of health despite the potentially harmful consumption of alcoholic beverages in the short and long run. The Court felt that the prohibition was compatible with the fundamental rights guaranteed at an EU-level and with the principle of proportionality.

Recent cases: the Netherlands
Claims on food packaging and in advertising are not only under scrutiny at the EU level, on a national level in the Netherlands, the Dutch Advertising Code Authority (Stichting Reclame Code) has been addressing misleading product advertisement under the self-regulatory regime of the Dutch Advertising Code. A case brought by a consumer and decided against the manufacturer under this Code in July 2012 concerned advertisement for a soft drink as ‘100% organic’ when it was not. Reference point is whether the average consumer would have made a purchasing decision based on these statements that he might otherwise not have.

Conclusion
Health claims in food labelling and advertising have become vital marketing tools to attract consumers’ attention and to differentiate products from competing products. On the one hand, EU consumers expect accurate information on products they buy, in particular when health claims are put forward. On the other hand, Member States, regulatory bodies and non-governmental consumer interest organisations have been given extra means to challenge these claims. The permitted health claims list is expected to have far-reaching consequences especially for the food supplement industry, as health and nutritional claims are their products’ main selling point. Given the potential impact of the regulation and its permitted list for the industry, Axon Lawyers will continue to actively monitor the developments in this area, including the legal action initiated against the Commission.

Lees de gehele bijdrage, inclusief voetnoten: hier.

Als randvermelding. In het september nummer van European Food and Feed Law tijdschrift is het "Country Report" voor Nederland verschenen van de hand van Ebba Hoogenraad en Christine Fontaine, Hoogenraad & Haak advertising + IP advocaten.

Lees hier de bijdrage "Fruity Dutch advertisements: how misleading are they?"

Een bijdrage van Erik Vollebregt, Axon Lawyers.

Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar [red. LSenR 257]. The judgment immediately brought one of my favorite Yogi Berra quotes to mind:

“You’ve got to be very careful if you don’t know where you are going, because you might not get there.”

This statement is spot on for this much anticipated judgment, which, as I already predicted, did not turn out as interesting as one had hoped because the EU Court does not have the competence to dive deep into the facts and resolve a preliminary reference on the facts. I predicted the court was very likely not going to give a useful answer to this question that would shed more light on how to answer the scientific questions as to how to demonstrate the absence or presence of a pharmacological effect and that is more or less what happened.

What was this about again?

We are dealing with an indirect pharmacological effect situation. As the court describes the facts:

“It is apparent from a monograph dating from 1994, on the properties, effects and possible applications of chlorhexidine, that mouthwash solutions containing a chlorhexidine solution of 0.2% reduce salivary bacteria and, in this way, have a therapeutic or clinical effect in cases of gingivitis.”

Kreussler argued that as a result of this indirect effect, there was a pharmacological effect that caused the mouthwash to be a medicinal product.

So what do we know more after this judgment?

In my opinion, not that much unfortunately.

First, we know now that a court can use MEDDEVs and other Commission guidance documents to resolve a problem of interpretation, and that a national court should stay within the boundaries of the law (i.e. the Medical Devices Directive or any other applicable directive) when interpreting such guidance. And we know that you should preferably use the relevant guidance, so you should use cosmetics guidance to resolve a cosmetics borderline dispute. So far nothing new or even remotely exciting.

Secondly, this case looked interesting because of its potential to really learn something about the interpretation of the concept ‘pharmacological’, one of key concepts determining the borderline between medical devices and medicinal products (as well as between medicinal products and other products). As you know, the last paragraph of the definition of medical device in article 1 (2) (a) of the Medical Devices Directive relies on it to demarcate devices and medicinal products. The question posed to the court was a rather technical one: the German judge dealing with the dispute asked whether

“for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, or whether an interaction between that substance and any cellular constituent present within the user’s body may be sufficient.”

Given the fuzziness and apodictic nature of its case law on the demarcation of medicinal products against other products so far the EU court was not going to allow itself to be painted into a corner by limiting the concept of pharmacological mode of action only to products that directly impact on the human biochemistry because, in the court’s words:

“that it is not apparent either from Directive 2001/83 or from the guidance document on the demarcation between the Cosmetic Products Directive and the Medicinal Products Directive that the molecules of the substance in question must necessarily interact with a human cellular constituent in order for it to be regarded as a substance which exerts a ‘pharmacological action’.”

and that

“a substance the molecules of which do not interact with a human cellular constituent may nevertheless, by means of its interaction with other cellular constituents present within the user’s organism, such as bacteria, viruses or parasites, have the effect of restoring, correcting or modifying physiological functions in human beings”

Further on in the judgment the court carefully repeats its case law that the effect must be “appreciable” and that this must follow from “an assessment, with due diligence, of each product individually, taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge”.

For the effect to count as pharmacological we already knew that we must look at (as the EU Court dutifully repeats for us in the judgment):

1. an effect, which must be appreciable
2. all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail
3. composition – including its content in active substances
4. use as intended

What we know more now is that we should still look at all of the above, but that the effect does not necessarily need to be direct (“ it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s body may be sufficient”).

The net result is a careful partial falsification of the concept “pharmacological” by the court by explanation of ‘what you cannot a priori exclude it to include’, but still no actual explanation of the concept that a scientist, regulatory professional or lawyer can really work with in day-to-day practice. Of course, falsification is sound scientific reasoning and yes, it does add some knowledge, but we would have liked more guidance from the court. However, with the other pending cases a pattern starts to emerge that will help manage the borderline of the medical devices regulation better. I will of course revisit this when judgments in the other cases have been rendered. Future developments in legislation will not change this I expect, because as far as I know from what is going on behind the scenes neither the definition of medical device nor that of medicinal products seem about to change. So, to get back to Yogi Berra: the EU Court took the fork in the road when it arrived at it, but we still don’t know where we are going- and if we will ever get there.

Een bijdrage (op persoonlijke titel) van John Lisman, Lisman Legal Life sciences.

Graag reageer ik op het artikel: ‘De e-sigaret is een medisch hulpmiddel en daarmee basta’ van mevrouw Hanneke van Lith [LS&R 223]. Mevrouw Van Lith geeft een informatief overzicht van jurisprudentie met betrekking tot verschillende sigaretachtige producten om te eindigen met een merkwaardige uitsmijter. Zij postuleert dat de e-sigaret inderdaad geen geneesmiddel is, maar in plaats daarvan een medische hulpmiddel als bedoeld in de Wet medische hulpmiddelen. De Europese definitie van medisch hulpmiddel luidt (Richtlijn 93/42/EEG zoals gewijzigd, art. 1, lid 2, onder a):

elk instrument, toestel of apparaat, elke software of stof of elk ander artikel dat of die alleen of in combinatie wordt gebruikt, met inbegrip van de software die door de fabrikant speciaal is bestemd om te worden gebruikt voor diagnostische en/of therapeutische doeleinden en voor de goede werking ervan benodigd is, door de fabrikant bestemd om bij de mens te worden aangewend voor:
— diagnose, preventie, bewaking, behandeling of verlichting van ziekten,
— diagnose, bewaking, behandeling, verlichting of compensatie van verwondingen of een handicap,
— onderzoek naar of vervanging of wijziging van de anatomie of van een fysiologisch proces,
— beheersing van de bevruchting,
waarbij de belangrijkste beoogde werking in of aan het menselijk lichaam niet met farmacologische of immunologische middelen of door metabolisme wordt bereikt, maar wel door dergelijke middelen kan worden ondersteund;

Ik vind de stelling dat de e-sigaret onder deze definitie valt vergezocht. Van belang voor de reikwijdte van de medische-hulpmiddelenrichtlijn is vooral het doel waarvoor de fabrikant het product bestemd: het beoogde gebruik. Mevrouw Van Lith betoogt dat de e-sigaret aangewend kan worden bij de ‘verlichting van rookverslaving’. Om binnen de definitie van medisch hulpmiddel te vallen, zou dan eerst vast moeten komen te staan dat rookverslaving een ziekte is en dat deze ziekte met een e-sigaret te ‘verlichten’ valt. Het bestempelen van een verslaving als een ziekte is niet alledaags, maar bij verlichting van de ziekte rookverslaving door het inhaleren van in gasvorm gebrachte nicotine kan ik mij helemaal niets voorstellen. Immers, de verslaving wordt er niet door verlicht, maar door in stand gehouden. In plaats van een rookverslaving krijgt men een nicotine-inademingsverslaving maar de schadelijke gevolgen zijn deels gelijk. Een tweede bezwaar van deze interpretatie dat de richtlijn ervan uitgaat wat het door de fabrikant beoogde doel van een medisch hulpmiddel is. Bij mijn weten is het doel van de fabrikanten van e-sigaretten niet om de rookverslaving te verlichten. Een derde – wellicht doorslaggevend – bezwaar van de indeling van de e-sigaret als medisch hulpmiddel is dat de belangrijkste beoogde werking – als dat zou zijn het verlichten van de rookverslaving – nu juist met farmacologische middelen wordt bereikt: de werking van het product berust mijns inziens op het farmacologisch effect van nicotine.

Mij bekroop bij het lezen van het stuk dat mevrouw Van Lith classificatie als medisch hulpmiddel ziet als een soort ‘geneesmiddel light’-regiem, omdat publieksreclame voor medische hulpmiddelen niet verboden is. Dit lijkt mij een merkwaardige beoordeling van de regulering van medische hulpmiddelen. Veel medische hulpmiddelen hebben een grotere invloed op het ‘daadwerkelijk beter’ worden van de patiënt dan menig ‘medicijn’.

Ik deel ten slotte de conclusie van mevrouw Van Lith dat de e-sigaret geen geneesmiddel is. Ik heb deze mening uitgebreid toegelicht in mijn noten in «JGR» («JGR» 2008/3 en 2012/2). De suggestie om toch ‘iets’ te regelen voor de e-sigaret door er de hoedanigheid van medisch hulpmiddel aan te geven is niet in lijn met Europese en nationale wetgeving.

John Lisman

Itte Overing, Gratis advies aan dé Thuisapotheek.nl, ICTRecht 1 maart 2012.

Een bijdrage van Itte Overing, ICTRecht.

De Nederlandse apothekers maken het ons, harde werkers, een stuk makkelijker. U kunt online uw medicatie bestellen. Hier zitten nogal wat juridische haken en ogen aan. Maar zoals blijkt uit de verschillende websites hebben de apothekers kaas gegeten van wat wel en niet mag zonder een bezoek aan een arts en recept. Wat men bij de Thuisapotheek echter vergeet, is dat de Wet Koop op Afstand en andere consument- en privacy- vriendelijke regels ook voor de online apotheker gelden. De patiënt is immers ook gewoon een consument.

Wilt u een herhaalrecept, men denke aan bijvoorbeeld de anticonceptiepil, dan is dat snel te regelen. Op een bestelling volgt een controle van uw huisarts waarna de medicatie wordt afgeleverd bij het door u opgegeven adres.

U kunt, zoals het hoort, niet zomaar (nieuwe) medicatie bestellen. Daarvoor is immers een bezoek aan de huisarts nodig.

Voorzover ik het gezien heb, wordt er geen reclame gemaakt voor medicijnen van bepaalde makers.

Waar gaat het hier dan mis? Allereerst mist er een SSL-verbinding, een beveiligde verbinding op het moment dat u uw persoonsgegevens achterlaat. Dit is verplicht op grond van de Wet bescherming persoonsgegevens. Dit geldt voor persoonsgegevens en nog meer voor bijzondere persoonsgegevens (lees hier: gezondheidsgegevens).

Persoonsgegevens zijn alle tot een persoon herleidbare gegevens. Concrete voorbeelden zijn NAW-gegevens maar ook welke huisarts iemand heeft. De bijzondere persoonsgegevens, gezondheidsgegevens, zijn bijvoorbeeld de door een bepaald persoon gebruikte medicatie en/of andere medisch-historische gegevens. Voor bijzondere persoonsgegevens gelden strengere regels daar het om gevoelige informatie gaat.

Waarom is het zo van belang dat deze regels secuur worden nageleefd? Als je het huidige debat over het EPD/LSP volgt, dan is met name de privacy het grootste struikelpunt. Daarnaast is er onlangs voorgesteld door de Europese Commissie dat de privacytoezichthouders zoals het College bescherming persoonsgegevens, flinke boetes kunnen gaan uitdelen aan bedrijven die zich niet aan de regels houden (tot 5% van de wereldwijde jaaromzet).

Ten tweede geldt ook voor apothekers net als voor andere online verkopers, dat zij zich moeten houden aan de regels omtrent de consumentenkoop en de koop op afstand. Dit betekent dat zij, onder andere, verantwoordelijk zijn voor de verzending van hun product. Als er iets misgaat dan mag de consument de apotheker hierop aanspreken. Deze verantwoordelijkheid mag niet worden uitgesloten in de algemene voorwaarden.

Ten derde zijn er de zwarte en de grijze lijst in boek 6 van het Burgerlijk Wetboek. De lijsten geven aan welke algemene voorwaarden niet gehanteerd mogen worden jegens consumenten daar zij onredelijk bezwarend (zwart) zijn of dat er vermoed wordt dat ze onredelijk bezwarend (grijs) zijn. Zo mag de bevoegdheid van de consument om bewijs te leveren niet worden beperkt of uitgesloten (zwart) en mag aansprakelijkheid niet worden uitgesloten (grijs) als hier niet een hele goede reden voor is.

Waarom bovenstaand relaas? Ik maak graag gebruik van een online apotheek en blijf dat ook graag doen.

Zustersites IE-Forum.nl en Reclameboek.nl hebben overzichten gepubliceerd met voor de praktijk relevante rechtspraak van het HvJ EU vanaf voorjaar 2010, inclusief conclusies en aanhangige prejudiciële vragen. Deze zullen dienst doen als living document: steeds als er arresten zijn gewezen, conclusies zijn genomen of verzoeken zijn neergelegd wordt dit overzicht bijgewerkt (in deze serie: auteursrecht, modellenrecht, merkenrecht, octrooirecht (incl. ABC) en reclamerecht).

Inhoudsopgave
A. HvJ EU
B. Gerecht EU
C. Conclusies AG HvJ EU
D. Aanhangige prejudiciële vragen
E. Hogere voorziening (verzoek)
F. Verder in de pijplijn (vragen nog niet definitief gesteld)
G. Aanhangig bij het Gerecht EU

Nieuwe Richtlijn Uitvoering euthanasie en hulp bij zelfdoding

Vandaag, 28 augustus 2012, publiceren artsenfederatie KNMG en apothekersorganisatie KNMP de richtlijn ‘Uitvoering euthanasie en hulp bij zelfdoding’. De richtlijn ondersteunt artsen en apothekers bij een effectieve en veilige uitvoering van euthanasie.

De richtlijn bevat praktisch goed toepasbare teksten met handvatten voor arts en apotheker in de gezamenlijke voorbereiding en evaluatie van een effectieve en veilige uitvoering van euthanasie en hulp bij zelfdoding. De richtlijn vervangt de KNMP Standaard Euthanatica uit 2007 en bevat onder meer aanwijzingen voor te gebruiken euthanatica, doseringen, wijze van uitvoering en toedieningsmaterialen.

Gedeelde verantwoordelijkheid
Euthanasie of hulp bij zelfdoding is in de eerste plaats voor de patiënt en diens naasten een ingrijpende gebeurtenis. Maar het is ook ingrijpend voor arts en apotheker. Zij worden niet dagelijks geconfronteerd met de uitvoering van euthanasie of het verlenen van hulp bij zelfdoding. KNMG en KNMP benadrukken met deze gezamenlijke richtlijn de persoonlijke én gedeelde verantwoordelijkheid van artsen en apothekers in dit proces.

Meer omschrijving

Webinar (vereist: installatie Apple Quicktime) en PowerPoint Slides "monoclonal antibodies: Dawn of a New Era" van 7 juni 2012.

Een bijdrage van Wouter Pors, Bird & Bird.

MAbs: How to protect them using patents and SPCs, Michael Alt, Partner, Germany, 2-34
Infringement Issues Relating to MAbs, Trevor Cook, Partner, United Kingdom, p. 35-47
New US biosimilar guidelines: Compared to the EU, Liz Fuller, Partner, France p. 48-79
An update on the regulatory framework for MAbs and ATMPs, Marc Martens p. 80-114.
An industry perspective Frank Landolt, IP and Legal Counsel, Ablynx, p. 115-151

Een bijdrage van Erik Vollebregt, Axon Lawyers.

While everybody is starting up again after the summer and had 26 September as first major horizon date in their head (the date on which the Commission has said it will publish the proposed new EU medical devices rules), the EU decided to go ahead and change the rules for (active) medical devices utilising tissues of animal origin in a separate legal instrument, a Commission Regulation.

What is it about?
Commission Regulation 722/2012 concerning active implantable medical devices and medical devices manufactured utilising tissues of animal origin has just been published in the Official Journal of the European Union on 9 August 2012. It replaces the existing requirements contained in Directive 2003/32/EC and provides for procedures required when using tissues from TSE-susceptible animals in medical devices. The Regulation will apply from 29 August 2013. The obligation for Member States to verify that Notified Bodies have the up-to-date expertise to assess the conformity of medical devices in line with Regulation 722/2012) will enter into force on 29 August 2012. The Regulation did not come as a complete surprise (because a publicly available draft version had been shared with WTO members as part of the obligations in the Technical Barriers to Trade committee), although the timing of a Commission Regulation being final and published is always difficult to predict. Furthermore, why couldn’t this subject wait for inclusion in the new Regulation that is supposed to cover both active implantable and ‘other’ medical devices by merging Directives 90/285 and 93/42?

Any important changes?
Yes, at least some, although it is mostly merging of the Directive and the MEDDEV that currently deal with this subject. New is that the instrument is a regulation, which is a logical step in the process of the EU regulating more by directly applicable regulation in the life sciences industry rather than by directive, the latter leaving the Member States too much wiggle room for own interpretation. The new regulation expands the scope by including active implantable medical devices under Directive 90/385. It covers devices utilising tissues of animal origin (non-viable tissues and tissue derivatives originating from bovine, ovine and caprine species, deer, elk, mink and cats, to be precise) and links to Regulation 1069/2009 that provides for rules for sourcing of animal by-products not used for human consumption, as well as to Decision 2007/453 with respect to assessing the risk of the source country.

The general system set up under Directive 2003/32 stays the same (Annex I prescribing specific essential requirements for the devices concerned, some of which are updated and some of which are new), except that the procedure has been streamlined in a way that we may see under the new regulation for high risk medical devices in response to the ENVI complaints that I wrote about here and here. The regulation sets up a system for regulatory fast-tracking of summary evaluation reports regarding use of starting materials that have obtained a ‘TSE certificate of suitability’ from the European Directorate for the Quality of Medicines, based on the ‘coordinating Competent Authority’ model set out in section 6.0 of the MEDDEV. The Regulation provides for a model summary evaluation report in Annex II.

I have heard through the grapevine that the new general medical devices regulation may use a similar system, allowing Member States to comment on the Notified Body’s evaluation of high risk devices prior to CE marking, except if the evaluation shows that the device has been designed and evaluated in conformity with EU standards developed by a body to be appointed for this, perhaps SCENHIR that issued scientific reports on among other things reprocessing of devices in the past and which is now working on breast implant guidelines, or the JRC, the Commission’s inhouse scientific service.

Another important but not so new novelty in the Regulation is that the manufacturer has a positive obligation to collect, evaluate and submit to the Notified Body information regarding changes with regard to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device (a responsible manufacturer would do this already because this was already included in section 8.0 of the the non-binding MEDDEV). If the Notified Body subsequently concludes that such information leads to an increase of the overall TSE risk, the conformity of the device concerned must be assessed again, including the step of involving member states’ competent authorities.

Finally, the Regulation is more prescriptive in the evaluation required for renewal of a certificate by a Notified Body by setting out a minimum list of aspects to be evaluated by the Notified Body.

Of course among the points not discussed in this post there are other interesting details, like the new rigorous process for tallow derivates, copied straight from Annex I of the MEDDEV, so also not that new but now mandatory.

Why couldn’t this wait for the revision?
For two simple reasons, I think. First, it will take quite a while for the revision to trickle through the legislative process and enter into force (three years likely, with another year of transitional period). Second, Commissioner Dalli has in no uncertain terms requested member states to increase market surveillance for medical devices in early 2012. Out of all possible things the Commission does not need another PIP breast implant-like scandal to put another dent in the reputation of EU medical devices regulation, so it must have decided that devices utilising tissues of animal origin had sufficient potential in that respect to warrant regulating them ahead of schedule. Part of the market surveillance increase effort was an appeal to Member States to check if their Notified Bodies were still up to the task. A clear hint to this effect is made in recital 8 and article 4 (1), obliging the Member States to verify that the notified bodies designated to assess the conformity of medical devices manufactured utilising animal tissues have the necessary expertise and up-to-date knowledge to perform this task and to inform the Commission by 28 February 2013 of their findings. It is not excluded that the new revision Regulation will absorb this Commission Regulation by superseding it when it enters into force, so manufacturers should consider starting to plan for that to happen.

With permission, CC-BY-SA medicaldeviceslegal.com.