On 1 February, a provision of the Dutch Patent Act 1995 came into force. It allows pharmacists to prepare patented medicines, on a small scale, for patients. The change aims to offer patients a cheaper alternative to branded pharmaceuticals and create more targeted methods of treatment.
2 April 2019 by Amy Sandys
Pharmacy compounding is commonplace in other European countries. The patented medicine must be prescribed, prepared by a pharmacist and issued for direct use to the patient on an individual basis. Such provisions on a larger scale would undermine the rights of the patent holder, says the Dutch government.
The goverment also indicates the provision will have a two-fold effect in preventing price hikes for medicines, and through extending compulsory licensing. As such, the change has attracted a lot of attention in the Netherlands, says Bert Oosting, partner at the Amsterdam office of Hogan Lovells.
Bert Oosting
Although the exemption is limited to individuals, a larger-scale impact is likely. It may increase litigation, given that previous regulations put limits on the extent to which medicines were compounded. “Now there may be litigation dealing with the intentions and questions behind pharmacy compounding,” says Oosting.
It may also blur the lines between at which scale compounding is acceptable. Amsterdam-based Hogan Lovells partner, Hein van den Bos, says “From a regulatory perspective, pharmacy compounding has been allowed for a long time but only under certain circumstances – this is clear under the European Court of Justice.”
Van den Bos says, “The Dutch government has taken a liberal approach and in some situations been lenient. Extension of pharmacy compounding is legally questionable.” There is speculation that the legislation compromises the provision of potentially better-quality branded products. Some argue, however, that targeted pharmacy compounding is beneficial for patient outcomes.
The exemption already applies in other European countries, including Germany, the UK and France. So for some, such a delay from the Netherlands is a surprise. “I think that passing the pharmacy exemption was never a priority for legislators,” says Oosting. “A pharmacy exemption is included in the agreement for a Unified Patent Court. But given the delay with the UPC launch, the Dutch government decided to pass the legislation.”
Hein van den Bos
The recent relocation of the European Medicines Agency (EMA) from London to Amsterdam intends to promote the Netherlands as a key location for the innovative life sciences sector.
However, with the pharmacy compounding exemption championed by the Dutch government, some suggest its position is somewhat at odds with the EMA move. But, “There is an appetite for the new law,” says van den Bos.
This sentiment is echoed by the Innovation Associated Medicines. It is largely concerned about the safety of drugs following the compounding procedure. “[Compounding] should remain an exception and only used in the case of special medical needs or to resolve a temporary shortage problem,” a spokesperson for the organisation told JUVE Patent.
“The biggest concern is that there is absolutely no guarantee for the safety of patients. Preparations are generally not as safe as registered medicines, since they are not tested and monitored for safety and quality in accordance with EU standards and not subject to good manufacturing prices.”
The Innovation Associated Medicines worries about the effect of the pharmacy exemption on research and development in new drugs. “Replacing registered medicines with unregistered pharmacy preparations for financial reasons… affects access for patients to new, or innovative, medicines. Especially for orphan drugs and drug rediscovery, incentives are taken away to invest in drug development.”
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.
Essential cookies enable basic functions and are necessary for the proper function of the website.
Name | |
---|---|
Provider | Owner of this website |
Purpose | Saves the visitors preferences selected in the Cookie Box of Borlabs Cookie. |
Cookie Name | borlabs-cookie |
Cookie Expiry | 1 Year |
Name | |
---|---|
Provider | Google LLC |
Purpose | Cookie by Google used to control advanced script and event handling. |
Privacy Policy | https://policies.google.com/privacy?hl=en |
Cookie Name | _ga,_gat,_gid |
Cookie Expiry | 1 Year |
Statistics cookies collect information anonymously. This information helps us to understand how our visitors use our website.
Accept | |
---|---|
Name | |
Provider | Google LLC |
Purpose | Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website. |
Privacy Policy | https://policies.google.com/privacy?hl=en |
Cookie Name | _ga,_gat,_gid |
Cookie Expiry | 1 Year |
Marketing cookies are used by third-party advertisers or publishers to display personalized ads. They do this by tracking visitors across websites.
Accept | |
---|---|
Name | |
Provider | Hotjar Ltd. |
Purpose | Hotjar is an user behavior analytic tool by Hotjar Ltd.. We use Hotjar to understand how users interact with our website. |
Privacy Policy | https://www.hotjar.com/legal/policies/privacy/ |
Host(s) | *.hotjar.com |
Cookie Name | _hjClosedSurveyInvites, _hjDonePolls, _hjMinimizedPolls, _hjDoneTestersWidgets, _hjIncludedInSample, _hjShownFeedbackMessage, _hjid, _hjRecordingLastActivity, hjTLDTest, _hjUserAttributesHash, _hjCachedUserAttributes, _hjLocalStorageTest, _hjptid |
Cookie Expiry | Session / 1 Year |
Content from video platforms and social media platforms is blocked by default. If External Media cookies are accepted, access to those contents no longer requires manual consent.
Accept | |
---|---|
Name | |
Provider | |
Purpose | Used to unblock Facebook content. |
Privacy Policy | https://www.facebook.com/privacy/explanation |
Host(s) | .facebook.com |
Accept | |
---|---|
Name | |
Provider | |
Purpose | Used to unblock Google Maps content. |
Privacy Policy | https://policies.google.com/privacy?hl=en&gl=en |
Host(s) | .google.com |
Cookie Name | NID |
Cookie Expiry | 6 Month |
Accept | |
---|---|
Name | |
Provider | |
Purpose | Used to unblock Instagram content. |
Privacy Policy | https://www.instagram.com/legal/privacy/ |
Host(s) | .instagram.com |
Cookie Name | pigeon_state |
Cookie Expiry | Session |
Accept | |
---|---|
Name | |
Provider | OpenStreetMap Foundation |
Purpose | Used to unblock OpenStreetMap content. |
Privacy Policy | https://wiki.osmfoundation.org/wiki/Privacy_Policy |
Host(s) | .openstreetmap.org |
Cookie Name | _osm_location, _osm_session, _osm_totp_token, _osm_welcome, _pk_id., _pk_ref., _pk_ses., qos_token |
Cookie Expiry | 1-10 Years |
Accept | |
---|---|
Name | |
Provider | |
Purpose | Used to unblock Twitter content. |
Privacy Policy | https://twitter.com/privacy |
Host(s) | .twimg.com, .twitter.com |
Cookie Name | __widgetsettings, local_storage_support_test |
Cookie Expiry | Unlimited |
Accept | |
---|---|
Name | |
Provider | Vimeo |
Purpose | Used to unblock Vimeo content. |
Privacy Policy | https://vimeo.com/privacy |
Host(s) | player.vimeo.com |
Cookie Name | vuid |
Cookie Expiry | 2 Years |
Accept | |
---|---|
Name | |
Provider | YouTube |
Purpose | Used to unblock YouTube content. |
Privacy Policy | https://policies.google.com/privacy?hl=en&gl=en |
Host(s) | google.com |
Cookie Name | NID |
Cookie Expiry | 6 Month |