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conferenceseries
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Volume 8
Journal of Biotechnology & Biomaterials
ISSN: 2155-952X
Pharma Biotech 2018
December 10-11, 2018
December 10-11, 2018 | Rome, Italy
23
rd
International Conference on
Pharmaceutical Biotechnology
Expensive drug costs, compulsory patent licensing and the limits to compounding by pharmacists
Hanneke Later-Nijland
Axon Lawyers, Netherlands
O
f late, the cost of medicines is a recurring subject of debate in Europe and it is anticipated that this topic will be discussed
more intensely in the years to come. In this regard, the application of compulsory patent licensing and the (wider)
application of the compounding exemption (formula magistralis) are seriously investigated by the Dutch Minister of Medical
Care as an instrument to curb the cost of medicines. In respect to the latter, a legislative proposal is underway which would
exonerate pharmacists from patent infringement when compounding medicinal products for direct use for individual cases on
medical prescription in pharmacies. This presentation explores in view of the applicable legislation and case law whether these
solutions have been correctly identified as the solution to the problem of expensive medicinal products. Pursuant to e.g. the
TRIPS Agreement, compulsory patent licensing in view of the general interest is (at least) to be used in combination with an
adequate remuneration. Nevertheless, it is worthwhile mentioning that a compulsory license in the public interest was recently
granted (and upheld in appeal) in Germany for the HIV drug Isentress. The available case law with respect to compounding
and the rationale thereof has demonstrated that it is solely to be utilized as an exception to the rule, which makes it unsuitable
as a general solution. Patients are not guaranteed for the same quality control as authorized medicinal products and therefore
a proper substantiated justification for this deviation is required. Such justification may when comparing European case law
probably not be sought in financial gain leaving aside the fact that this affects the level playing field. This presentation is very
relevant for parties manufacturing or marketing high-cost medicinal products.
Recent Publications
1. Later-Nijland (2018) Annotation to e.g. ECLI:NL:RBDHA:2017:12046 “The Alimta cases” (Patent infringement cases
concerning Alimta) Jurisprudentie Geneesmiddelenrecht (‘Case law Pharmaceutical law’), (Apr 6) 2018, Sdu [in Dutch]
2. Later-Nijland (2018) Annotation to ECLI:NL:RVS:2017:1175 “The Biodent case” (The Dutch Council of State rules that
this caries protection product should be classified as both a medicinal product by presentation as well as a medicinal
product by function) Jurisprudentie Geneesmiddelenrecht (‘Case law Pharmaceutical law’), Apr, 2018, Sdu [in Dutch]
3. Later-Nijland H. (2016) Statutory prohibition inducements concerning medical devices upcoming, Life Sciences &
recht, Jan 26, DeLex
<https://www.lsenr.nl/artikelen/wettelijk-verbod-op-gunstbetoon-met-betrekking-tot-medische-
hulpmiddelen-op- handen> [in Dutch]
4. Nijland HM J, Ruslami R, Stalenhoef J E, Nelwan E J, Alisjahbana B, Nelwan R H, Ven A J AM van der, Danusantoso H,
Aarnoutse R E and Crevel R van (2006) Exposure to rifampicin is strongly reduced in patients with tuberculosis and type
2 diabetes. Clinical Infectious Disease 43(7):848-854.
5. Nijland HM J, L'homme R F A, Rongen G A P J M, Uden P van, Crevel R van, Boeree M J, Aarnoutse R E, Koopmans P
P and Burger DM (2008) High incidence of adverse events in healthy volunteers receiving rifampicin and adjusted doses
of lopinavir/ritonavir. AIDS. 22(8):931-5.
Hanneke Later-Nijland, J Biotechnol Biomater 2018, Volume 8
DOI: 10.4172/2155-952X-C8-109