RECOMANDARE privind propunerea de decizie a Consiliului de acceptare, în numele Comunităţii Europene, a Protocolului de modificare a Acordului privind drepturile de proprietate intelectuală care se referă la comerţ (TRIPS), încheiat la Geneva, la 6 decembrie 2005

22.10.2007 - (8934/2006 – C6-0359/2006 – 2006/0060(AVC)) - ***

Comisia pentru comerţ internaţional
Raportor: Gianluca Susta

Procedură : 2006/0060(AVC)
Stadiile documentului în şedinţă
Stadii ale documentului :  
A6-0403/2007

PROIECT DE REZOLUŢIE LEGISLATIVĂ A PARLAMENTULUI EUROPEAN

privind propunerea de decizie a Consiliului de acceptare, în numele Comunităţii Europene, a Protocolului de modificare a Acordului privind drepturile de proprietate intelectuală care se referă la comerţ (TRIPS), încheiat la Geneva, la 6 decembrie 2005

(8934/2006 – C6-0359 – 2006/0060(AVC))

(Procedura de aviz conform)

Parlamentul European,

–   având în vedere propunerea de decizie a Consiliului (8934/2006),

–   având în vedere Protocolul de modificare a Acordului privind drepturile de proprietate intelectuală care se referă la comerţ (TRIPS), încheiat la Geneva, la 6 decembrie 2005,

–   având în vedere cererea de aviz conform prezentată de Consiliu în conformitate cu articolul 300 alineatul (3) al doilea paragraf, coroborat cu articolul 133 alineatul (5) şi articolul 300 alineatul (2) primul paragraf prima teză din Tratatul CE (C6-0359/2006),

–   având în vedere articolul 75 şi articolul 83 alineatul (7) din Regulamentul de procedură,

–   având în vedere recomandarea Comisiei pentru comerţ internaţional şi avizul Comisiei pentru afaceri juridice (A6-0403/2007),

1.  îşi dă avizul conform cu privire la modificarea acordului;

2.  încredinţează Preşedintelui sarcina de a transmite poziţia Parlamentului Consiliului, Comisiei, precum şi guvernelor şi parlamentelor statelor membre.

EXPUNERE DE MOTIVE

Background

The TRIPS Agreement adopted in 1994 extends the basic legal principles of the World Trade Organisation to the area of intellectual property and increases minimum protection standards for intellectual property.

The significant costs associated with the introduction of higher intellectual property protection standards in developing countries generated intense discussion, particularly as to whether increased patent protection under the rules of the TRIPS Agreement impeded access to affordable medicines in poor countries.

The WTO Ministerial Conference held in Doha in 2001 culminated in the adoption of the 'Doha Declaration', which stressed that the TRIPS Agreement could and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.

In addition to affirming existing 'flexibilities' in the TRIPS Agreement, the declaration recognised that countries with insufficient or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing and instructed the Council for TRIPS to find an 'expeditious solution' to this problem.

After long and difficult negotiations, the Council for TRIPS reached an agreement which was adopted by a decision of the general Council of the WTO on 30 August 2003.

This decision spells out the circumstances under which countries with insufficient or no manufacturing capacity in the pharmaceutical sector can make effective use of compulsory licensing and import generic versions of drugs still under patent, subject to a large number of conditions in both the exporting and importing country.

To render the mechanism established in the decision operational, implementation at national or - as in the case of the European Union - regional level was required.

To that end, in October 2004 the Commission presented, under the co-decision procedure, a proposal for a regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.

The proposal contained a large number of charges and conditions in addition to the substantial number already envisaged in the WTO decision. The rapporteur, Mr Van Hecke, accordingly directed his efforts to ensuring that the text transposed the WTO decision as faithfully as possible, by seeking to remove all additional conditions which would have rendered the - already extremely complex - mechanism even more complicated, confusing and, in effect, unusable.

On 12 July 2005 the Committee on International Trade adopted the report by a very large majority, with a couple of abstentions.

In the run-up to the forthcoming WTO ministerial conference in Hong Kong, strengthened by the solid report he had received from the committee, Mr Van Hecke, instead of seeking the report's immediate adoption in plenary, launched, in close cooperation with the shadow rapporteurs of the other political groups, an informal trialogue with the Commission and the Council with a view to achieving interinstitutional agreement on first reading before the Hong Kong conference and thus strengthening the European Union's position in the multilateral negotiations.

In the course of the trialogue, the rapporteur negotiated a compromise on the assumption that the regulation represented only a temporary solution and that the European Parliament would be consulted again when a permanent amendment was adopted, which still seemed to be a distant prospect at that time.

In its report, our committee had specifically asked the Commission to present, at three-year intervals after the entry into force of the regulation, a report on its operation, in order to monitor the use made of the mechanism it introduced.

The text adopted by the Committee on International Trade was more ambitious than the final compromise text, particularly with regard to technology transfer and capacity building in the developing countries, the remuneration of right holders, the simplified and accelerated procedure and the non-suspensory effect of appeals.

Nevertheless, Parliament's input greatly improved the Commission's original proposal.

The compromise reached by the three institutions was eventually adopted by Parliament on first reading on 1 December 2005 and by the Council on 27 April 2006, thus transposing the temporary waiver into Community law.

On 6 December 2005, a few days after Parliament had adopted the regulation, the WTO General Council adopted a decision on a permanent amendment to the TRIPS Agreement.

It was in the light of this permanent amendment that the Commission submitted the present proposal for a Council decision accepting the Protocol amending the TRIPS Agreement.

The European Parliament has to decide whether to give its assent to this proposal.

If the protocol is accepted by the European Union, the European Parliament will be consulted again, under the codecision procedure, on the proposal to amend the regulation transposing the protocol into Community law.

Substance of the proposal

Your rapporteur considers that the issue at stake goes far beyond simply assenting to an international protocol. The problem addressed is of huge political and humanitarian importance: access to medicines in the developing and less-developed countries where they are most needed, but which cannot pay the high prices set by the pharmaceutical industry.

This being so, your rapporteur wishes to make the following comments:

(1)      The protocol has been submitted to all WTO members and is open for acceptance until 1 December 2007 or such later date as may be decided by the ministerial conference.

          The protocol will enter into force upon acceptance by two-thirds of WTO members. Pending such acceptance, the waiver (the 2003 decision) will continue to be the legal basis.

The European Union has already transposed the waiver into law, and consequently delaying acceptance of the protocol until after 1 December would not create a legal vacuum, but could allow time to assess the effectiveness of the proposed mechanism to be assessed and whether it should be made permanent.

(2)       To date, only seven countries (out of the 150 WTO members), or 4.7% of the membership, have accepted the permanent amendment of the TRIPS agreement: the United States, Switzerland, El Salvador, the Republic of Korea, Norway, India and the Philippines.

           If the European Union did not accept the protocol by 1 December 2007, it would not be alone, and it is by no means certain that the objective of acceptance by two thirds of the membership (100 countries) could be achieved by that date.

(3)       The amendment did not have to be a mere 'cut and paste' of the WTO decision of 30 August 2003, but the opposition of some WTO member states made it impossible to adopt an amendment allowing easier access to medicines.

(4)       The WTO decision of 30 August 2003 was supposed to provide an 'expeditious solution' to the crisis in access to medicines faced by developing countries with little manufacturing capacity, but there is no proof of the decision's efficacy.

           To date, only Canada, Norway, China, Korea, India and the European Union have adopted legislation transposing the decision into their own law. In the last four years, not one importing country has notified the Council for TRIPS that it intends to use the mechanism to import cheaper life-saving medicine.

Conclusions

It seems, therefore, that the mechanism is not particularly effective, and does not provide a satisfactory means of resolving the problem of accessing medicines at affordable prices.

The European Parliament can now decide whether to:

-          give its assent,

-          withhold its assent, or

-          postpone its assent.

One of the questions raised is whether it would be preferable to ascertain the effectiveness of the mechanism introduced by the 2003 decision and carry out a review of the use made of the flexibilities offered by the TRIPS Agreement before making it permanent.

Postponing its assent would enable the European Parliament to ascertain whether at least two thirds of Member States accepted the protocol by 1 December and, if not, to consider whether, in the near future, the European Union ought to launch an initiative at the WTO to revise the decision with a view to making it a more genuinely effective instrument; ascertain the effectiveness of the mechanism; and ascertain whether the bilateral agreements currently being negotiated by the Commission (in particular, the economic partnership agreements with the ACP countries and other agreements negotiated with less-developed countries) contain higher levels of intellectual property protection than those contained in the TRIPS Agreement.

This would also enable the European Union to make every effort, in the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property set up by the WHO in 2006, to encourage the use of the flexibilities legally provided for under the TRIPS agreement.

However, in view of the fact that, in the present circumstances, it would probably be very difficult to renegotiate the protocol, your rapporteur considers that the European Parliament could give its assent if it received a firm Council commitment to:

-   State that the mechanism created by the WTO Decision of 30 August 2003 and the Protocol to the TRIPS Agreement represents, at best, only a small part of the solution to the problem of access to medicines at affordable prices.

-   Adopt a Joint Policy Statement with the European Parliament to the effect that EU Member States are free to use the Article 30 exception provision of the TRIPS Agreement under their domestic patent law to authorise production and export 'to address public health needs in importing Members', and mandate the European Commission to refrain from taking action to interfere with these proceedings.

-    Mandate the European Commission

-    not to negotiate pharmaceutical-related TRIPS-plus provisions affecting public health and access to medicines in the Economic Partnership Agreements (EPAs) with the ACP countries and other future bilateral and regional agreements with poor developing countries

-    to refrain from requesting adherence to or acceptance of the obligations of the Patent Cooperation treaty and the Patent Law Treaty, to refrain from incorporating the terms of Directive 2004/48/EC on the enforcement of intellectual property rights and to not introduce disciplines such as nonoriginal database protection in the EPAs with the ACP countries.

-   State that the European Union supports the developing countries which use the so-called flexibilities built into the TRIPS Agreement in order to be able to provide essential medicines at affordable prices under their domestic public health programs.

-   Mandate the European Commission to explore new solutions such as 'pool procurement strategies' which could be used by countries or groups of countries to find viable and long-lasting solutions to the problem of access to medicines at affordable prices and stimulate direct investment in local production facilities within a region.

-   Mandate the European Commission to pro-actively support the work of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property process at the WHO.

-   Recognise that the European Union must take additional measures as a matter of urgency with a view to encouraging the transfer of technology, research, capacity strengthening, regional supply systems and help with registration, in order to facilitate and increase the production of pharmaceutical products by the developing countries themselves. The EU must commit to a specified level of funding to upgrade or construct pharmaceutical production facilities owned by local persons in developing (including Least Developed) Countries, and increase its aggregate funding to public private partnerships pursuing research and development of medicines of special relevance to developing countries.

AVIZUL COMISIEI PENTRU AFACERI JURIDICE (28.6.2007)

destinat Comisiei pentru comerţ internaţional

referitor la propunerea de decizie a Consiliului privind acceptarea, în numele Comunităţii Europene, a protocolului de modificare a Acordului TRIPs, realizat la Geneva, la 6 decembrie 2005

(8934/2006 – C6‑0359/2006 – 2006/0060(AVC))

Raportor pentru aviz: Michel Rocard

AVC

JUSTIFICARE SUCCINTĂ

Comisia pentru afaceri juridice a primit solicitarea de a formula un aviz destinat Comisiei pentru comerţ internaţional, competentă în fond, referitor la propunerea de decizie a Consiliului privind acceptarea, în numele Comunităţii Europene, a protocolului de modificare a Acordului privind aspectele comerciale ale drepturilor de proprietate intelectuală, realizat la Geneva, la 6 decembrie 2005.

Chiar înainte de a avea la dispoziţie lucrări şi studii care să-i permită analizarea acestei chestiuni, Comisia pentru afaceri juridice a Parlamentului European ar dori să facă următoarele observaţii:

-          în 2005, Parlamentul European, reprezentat la vremea respectivă în această privinţă de raportorul său, dl Van Hecke, a participat la elaborarea compromisului pe care ni se solicită în prezent să îl definitivăm, însă a solicitat ca, înainte de adoptarea acestui compromis, să se evalueze mecanismul temporar conceput, iar Parlamentul să fie consultat din nou în urma acestei evaluări. Între timp, compromisul a fost adoptat, însă niciuna dintre aceste cerinţe nu a fost respectată;

-          ni se solicită să aprobăm propunerea, deşi nu există niciun raport în care să se stabilească în mod formal utilitatea reală a deciziei pe care OMC a adoptat-o în august 2003;

-          de la adoptarea protocolului de către OMC, la 6 decembrie 2005 - acum mai mult de şaisprezece luni - doar 7 dintre cele 150 de ţări interesate au acceptat în mod explicit modificarea definitivă a Acordului TRIPs, respectiv Statele Unite, Elveţia, Salvador, Republica Coreea, Norvegia, India şi Filipine, adică un număr surprinzător de redus;

-          în cursul ultimilor trei ani şi jumătate, nicio ţară importatoare nu a informat Consiliul TRIPs cu privire la intenţia sa de a utiliza mecanismul pentru a importa medicamente esenţiale la un cost mai scăzut.

Înainte de efectuarea unui studiu aprofundat, aceste observaţii, de natură pur procedurală, ridică serioase semne de întrebare privind pertinenţa propunerii care ni se prezintă.

Prin urmare, Comisia pentru afaceri juridice a hotărât să adreseze următoarele concluzii Comisiei pentru comerţ internaţional:

-          regretă faptul că dispoziţiile privind licenţele obligatorii nu îmbunătăţesc perspectivele unor medicamente mai ieftine pentru ţările sărace, în măsura în care acest lucru se poate justifica din punct de vedere umanitar;

-          recunoaşte că vor trece mai mulţi ani până când brevetele de produse farmaceutice din India, care au apărut abia în 2005, vor fi supuse cerinţelor prevăzute în dispoziţiile privind licenţele obligatorii şi că aceste cerinţe se vor aplica doar în cazul medicamentelor noi şi brevetate;

-          observă că Regulamentul (CE) nr. 816/2006[1] conţine aceleaşi dispoziţii, care sunt extinse la mai multe ţări decât cele prevăzute în modificarea Acordului TRIPs;

-          subliniază necesitatea unei strânse cooperări cu Comisia pentru comerţ internaţional în ceea ce priveşte analiza ulterioară a implicaţiilor acestei chestiuni şi necesitatea menţinerii unui dialog cu Consiliul şi Comisia asupra îmbunătăţirilor care trebuie aduse sistemului actual.

Comisia pentru afaceri juridice a hotărât totuşi să invite Comisia pentru comerţ internaţional, competentă în fond, să îşi dea avizul conform, în timp util, faţă de propunerea de decizie a Consiliului privind acceptarea, în numele Comunităţilor Europene, a protocolului de modificare a Acordului TRIPs, realizat la Geneva, la 6 decembrie 2005.

PROCEDURĂ

Titlu

Protocol de modificare a Acordului privind aspectele comerciale ale drepturilor de proprietate intelectuală (TRIPS)

Referinţe

08934/2006 - C6-0359/2006 - COM(2006)0175 - 2006/0060(AVC)

Data cererii avizului conform al PE

6.12.2006

Comisia competentă în fond

INTA

Aviz emis de către

       Data anunţului în plen

JURI

14.12.2006

 

 

 

Raportor pentru aviz

       Data numirii

Michel Rocard

29.1.2007

 

 

Examinare în comisie

11.6.2007

 

 

 

Data adoptării

25.6.2007

 

 

 

Rezultatul votului final

+:

–:

0:

14

3

Membri titulari prezenţi la votul final

Bert Doorn, Cristian Dumitrescu, Giuseppe Gargani, Lidia Joanna Geringer de Oedenberg, Othmar Karas, Piia-Noora Kauppi, Klaus-Heiner Lehne, Manuel Medina Ortega, Hartmut Nassauer, Francesco Enrico Speroni

Membri supleanţi prezenţi la votul final

Sharon Bowles, Luis de Grandes Pascual, Kurt Lechner, Marie Panayotopoulos-Cassiotou, Gabriele Stauner, József Szájer, Jacques Toubon

  • [1]  Regulamentul (CE) nr. 816/2006 al Parlamentului European şi al Consiliului din 17 mai 2006 privind acordarea de licenţe obligatorii pentru brevetele referitoare la fabricarea produselor farmaceutice destinate exportului în ţări cu probleme de sănătate publică (JO L 157, 9.6.2006, p. 1)

PROCEDURĂ

Titlu

Protocol de modificare a Acordul privind aspectele comerciale ale drepturilor de proprietate intelectuală (TRIPS)

Referinţe

08934/2006 - C6-0359/2006 - COM(2006)0175 - 2006/0060(AVC)

Data cererii avizului conform al PE

6.12.2006

Comisia competentă în fond

       Data anunţului în plen

INTA

14.12.2006

Comisia (comisiile) sesizată(e) pentru avizare

       Data anunţului în plen

DEVE

14.12.2006

ENVI

14.12.2006

JURI

14.12.2006

 

Avize care nu au fost emise

       Data deciziei

DEVE

10.9.2007

ENVI

14.6.2006

 

 

Raportor(i)

       Data numirii

Gianluca Susta

27.2.2007

 

 

Raportor(i) substituit (substituiţi)

Johan Van Hecke

 

 

Examinare în comisie

8.5.2007

28.6.2007

17.7.2007

12.9.2007

 

9.10.2007

 

 

 

Data adoptării

22.10.2007

 

 

 

Rezultatul votului final

+:

–:

0:

24

0

3

Membri titulari prezenţi la votul final

Kader Arif, Francisco Assis, Françoise Castex, Christofer Fjellner, Béla Glattfelder, Ignasi Guardans Cambó, Sajjad Karim, Alain Lipietz, Marusya Ivanova Lyubcheva, Erika Mann, Helmuth Markov, Vural Öger, Georgios Papastamkos, Godelieve Quisthoudt-Rowohl, Tokia Saïfi, Gianluca Susta, Corien Wortmann-Kool, Zbigniew Zaleski

Membri supleanţi prezenţi la votul final

Vittorio Agnoletto, Vasco Graça Moura, Małgorzata Handzlik, Glenys Kinnock, Javier Moreno Sánchez, Ivo Strejček

Membri supleanţi (articolul 178 alineatul (2)) prezenţi la votul final

Den Dover, Thijs Berman, Milan Gaľa