[Ip-health] Highlights from the European Union's 17 May 2007 regulation on compulsory licensing

[James Packard Love]

In light of the disputes involving Thailand CLs, it might be useful
to review these highlights from the European Union's 17 May 2007
regulation on compulsory licensing under the 30 August 2003 WTO
decision.

1.  There are no limits on the scope of diseases.  It extends to all
medicinal products as defined in Article 1(2) of Directive 2001/83/EC
on medicinal products for human use (1), active ingredients and
diagnostic kits ex vivo.

2.  The compulsory licenses are mandatory:  "Member States shall
grant a compulsory licence to any person making an application in
accordance with Article 6 and subject to the conditions set out in
Articles 6 to 10."

3.  Prior negotiation with right owners is waived "in situations of
national emergency or other circumstances of extreme urgency or in
cases of public non-commercial."  In these cases,  "the remuneration
shall be a maximum of 4 % of the total price to be paid by the
importing country."   In other cases, remuneration may consider
"humanitarian or noncommercial circumstances relating to the issue of
the licence."

4.  The "safety and efficacy of medicinal products" may be evaluated
through evaluation of "the scientific opinion procedure as provided
for under Article 58 of Regulation (EC) No 726/2004, or . . . any
similar procedures under national law, such as scientific opinions or
export certificates intended exclusively for markets outside the
Community."

5.   In Article 18.2,  when compulsory licenses to data are issued
under this regulation, EU "protection periods" for test data "shall
not apply."   This waiver of data exclusivity for a case involving a
compulsory license is quite important.  Note that the remuneration
for the patent is the sole remuneration in such cases.

Jamie


REGULATION (EC) No 816/2006 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 17 May 2006 on compulsory licensing of patents relating to
the manufacture of pharmaceutical products for export to countries
with public health problems

Whereas:

(1) On 14 November 2001 the Fourth Ministerial Conference of the
World Trade Organisation (WTO) adopted the Doha Declaration on the
Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS Agreement) and Public Health. The Declaration recognises that
each WTO Member has the right to grant compulsory licences and the
freedom to determine the grounds upon which such licences are
granted. It also recognises that WTO Members with insufficient or no
manufacturing capacity in the pharmaceutical sector could face
difficulties in making effective use of compulsory licensing.

(2) On 30 August 2003 the WTO General Council, in the light of the
statement read out by its Chairman, adopted the Decision on the
implementation of paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health (the Decision). Subject to certain
conditions, the Decision waives certain obligations concerning the
issue of compulsory licences set out in the TRIPS Agreement in order
to address the needs of WTO Members with insufficient manufacturing
capacity.


(14) In order to ensure the efficient processing of applications for
compulsory licences under this Regulation, Member States should have
the ability to prescribe purely formal or administrative
requirements, such as rules on the language of the application, the
form to be used, the identification of the patent(s) and/or
supplementary protection certificate(s) in respect of which a
compulsory licence is sought, and rules on applications made in
electronic form.

(15) The simple formula for setting remuneration is intended to
accelerate the process of granting a compulsory licence in cases of
national emergency or other circumstances of extreme urgency or in
cases of public noncommercial use under Article 31(b) of the TRIPS
Agreement. The figure of 4 % could be used as a reference point for
deliberations on adequate remuneration in circumstances other than
those listed above,

Article 1
Scope
This Regulation establishes a procedure for the grant of compulsory
licences in relation to patents and supplementary protection
certificates concerning the manufacture and sale of pharmaceutical
products, when such products are intended for export to eligible
importing countries in need of such products in order to address
public health problems.

Member States shall grant a compulsory licence to any person making
an application in accordance with Article 6 and subject to the
conditions set out in Articles 6 to 10.

Article 2
Definitions
For the purposes of this Regulation, the following definitions shall
apply:
(1) =91pharmaceutical product=92 means any product of the pharmaceutical
sector, including medicinal products as defined in Article 1(2) of
Directive 2001/83/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating to medicinal products
for human use (1), active ingredients and diagnostic kits ex vivo;

[ Note:  This is:  2. Medicinal product: (a) Any substance or
combination of substances presented as having properties for treating
or preventing disease in human beings; or (b) Any substance or
combination of substances which may be used in or administered to
human beings either with a view to restoring, correcting or modifying
physiological functions by exerting a pharmacological, immunological
or metabolic action, or to making a medical diagnosis.]


Article 6
Application for a compulsory licence

4. Purely formal or administrative requirements necessary for the
efficient processing of the application may be prescribed under
national law. Such requirements shall not add unnecessarily to the
costs or burdens placed upon the applicant and, in any event, shall
not render the procedure for granting compulsory licences under this
Regulation more burdensome than the procedure for the granting of
other compulsory licences under national law.


Article 7
Rights of the rights-holder
The competent authority shall notify the rights-holder without delay
of the application for a compulsory licence. Before the grant of the
compulsory licence, the competent authority shall give the rights-
holder an opportunity to comment on the application and to provide
the competent authority with any relevant information regarding the
application.


Article 9
Prior negotiation
1. The applicant shall provide evidence to satisfy the competent
authority that he has made efforts to obtain authorisation from the
rights-holder and that such efforts have not been successful within a
period of thirty days before submitting the application.
2. The requirement in paragraph 1 shall not apply in situations of
national emergency or other circumstances of extreme urgency or in
cases of public non-commercial use under Article 31(b) of the TRIPS
Agreement.


Article 10
Compulsory licence conditions

9. The licensee shall be responsible for the payment of adequate
remuneration to the rights-holder as determined by the competent
authority as follows:
(a) in the cases referred to in Article 9(2), the remuneration shall
be a maximum of 4 % of the total price to be paid by the importing
country or on its behalf;
(b) in all other cases, the remuneration shall be determined taking
into account the economic value of the use authorised under the
licence to the importing country or countries concerned, as well as
humanitarian or noncommercial circumstances relating to the issue of
the licence.

Article 11
Refusal of the application
The competent authority shall refuse an application if any of the
conditions set out in Articles 6 to 9 are not met, or if the
application does not contain the elements necessary to allow the
competent authority to grant the licence in accordance with Article
10. Before refusing an application, the competent authority shall
give the applicant an opportunity to rectify the situation and to be
heard.

Article 18
Safety and efficacy of medicinal products
1. Where the application for a compulsory licence concerns a
medicinal product, the applicant may avail himself of:
(a) the scientific opinion procedure as provided for under Article 58
of Regulation (EC) No 726/2004, or
(b) any similar procedures under national law, such as scientific
opinions or export certificates intended exclusively for markets
outside the Community.
2. If a request for any of the above procedures concerns a product
which is a generic of a reference medicinal product which is or has
been authorised under Article 6 of Directive 2001/83/EC, the
protection periods set out in Article 14(11) of Regulation (EC) No
726/2004 and in Articles 10(1) and 10(5) of Directive 2001/83/EC
shall not apply.

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James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"