[Ip-health] Medicines Law & Policy: Faced with unreasonable medicines prices, the Netherlands introduces pharmacy exemption in patent law.

Thiru Balasubramaniam thiru at keionline.org
Fri Feb 22 06:36:23 PST 2019



Faced with unreasonable medicines prices, the Netherlands introduces
pharmacy exemption in patent law.
 Ellen 't Hoen <https://medicineslawandpolicy.org/author/ellen/>
February 22, 2019

On 1 February 2019, article 53(3), second sentence of the Dutch Patent Act
1995 came into force introducing a patent exemption for the preparation of
medicines in a pharmacy.

Article 53(1) of the Dutch Patent Act provides the usual list of exclusive
acts reserved for the patent holder: to make, use, put on the market or
resell, hire out or deliver the patented product, or otherwise deal in it
in or for his business, or to offer, import or stock it for any of those
purposes. The law now provides an exemption for pharmacy preparation to
these exclusive acts. The new provision reads:

*“3. […] The exclusive right shall neither extend to the preparation for
direct use for individual cases on medical prescription of medicines in
pharmacies, nor to acts concerning the medicines thus prepared.”*

In a letter to parliament
the minister describes the conditions under which pharmacy preparation may
take place: the medicine has to be for individual patients and on
prescription by a physician and not for production on a structural scale.
Other European countries have similar patent exemptions for pharmacy
preparation in their patent laws. The introduction of the pharmacist
exemption was recommended to the government by the Council for Public
Health and Society in its report *Development of new medicines; Better,
faster, cheaper*
November 2017.

The pharmacists who are preparing low-cost medicines are popular in the

For example, the pharmacy of the Amsterdam University Medical Centre
received €5 million from the Vrienden Lotterij
Lottery) for the preparation of chenodeoxycholic acid (CDCA) for the
treatment of  cerebrotendinous xanthomatosis (CTX), a rare metabolic
disease. Leadiant, the company that sells the product commercially, had
increased the price of the product 500 fold to €153,300 per patient per
year. Leadiant has a monopoly position in the market since it obtained an
orphan drug status for the product in the EU. The Pharmaceutical
Accountability Foundation has requested
<https://www.farmaterverantwoording.nl/information-in-english/> the Dutch
competition authority to take action against Leadiant. In the mean time,
the pharmacy preparation can offer relief for CTX patients that depend on
the medicine. See here
more information about the CDCA story.

A similar development
the cancer drug, lutetium-octreotaat, that since 18 years is produced by
hospital pharmacists in the Netherlands. After Novartis acquired the
exclusive marketing rights to the product, it increased the price of one
infusion from €4,000 to €23,000 bringing the total cost of one treatment to
€100,000. According to the Dutch Medical Journal
Novartis has also acquired the producer of the raw materials needed to make
the treatment. Novartis has said that it will continue to supply raw
material for pharmacy preparation but it is not known at what price.

Pharmacy production of lower-priced medicines depends on the availability
of raw materials. The Dutch competition authority, Authority for Consumers
& Markets (ACM), announced
week that it will sharply monitor the developments around medicines
including the production of orphan drugs by pharmacies. The ACM sent a
warning signal
drug companies and suppliers of active pharmaceutical ingredients and told
them not to create unjustified barriers to pharmacy production for example
by restricting access to raw materials or by setting unreasonable

On 17 January, the pharmacist Paul Lebbink established a new laboratory in
his pharmacy <https://www.transvaalapotheek.nl/> in The Hague where he
plans to make lower-cost versions of expensive medicines. Health Minister
Bruno Bruins embraced the initiative and opened the new laboratory by
making a few capsules himself
made for great footage for the evening news <http://owst.nl/qkaN>.

The pharmaceutical industry lobby group *Vereniging *Innovatie
* Geneesmiddelen* was quick to condemn production of lower cost medicines
by pharmacists. Despite the recent legal changes, they maintain the position
that preparation in a pharmacy of a patented medicine to lower the cost
constitutes an infringement of patent law.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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