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Within EU without patents, but without patents for life!Sign our petition!

Эта петиция собрала 27 подписантов


To:                  Martin Schulz, President of the European Parliament

Copy:              Subcommittee on Human Rights of the European Parliament

                       Committee on Petitions of the European Parliament

                       Foreign Affairs Committee of the European Parliament

Subject:           Theintention to sign Association agreement, including the Deep and Comprehensive Free Trade Area, between the European Union and Georgia, Republic of Moldova and Ukraine(the last of thesecurrently postponed).

On behalf of the civil society and people living with HIV in Eastern Europe we would like to express our concern regarding the negotiations for a Deep and Comprehensive Free Trade Area (DCFTA), as part of the Association Agreement (“Agreement”) between the European Union and the Republic of Moldova, Georgia and Ukraine (with the last of thesenegotiations currently stopped), namely, the clauses of the Agreement which may adversely affect the access to medical products.

We fully support and extremelywelcome the integration of our countries into the European Union and our concerns are related not to the process itself but to the potential consequences of some parts of the Agreement which may hinder the increased of access to HIV/AIDS treatment in the region, where the access to antiretroviral drugs is one of the lowest in the world.  According to the European Office of the World Health Organization, only 30% of those in need of antiretroviral treatment receive it.

To prevent the negative outcomes associated with the imminent increase in prices of antiretroviral drugs, we call you to apply to the European Commission with the proposal to exclude the following clauses from the draft Agreements:

introduction of “data exclusivity” with regard to medical products;

supplementary protection certificates that allow extension of the validity  of the drug patents;

criminal responsibility for the violation of patent rights and application of customs procedures with regard to the assets under patent protection, i.e. inventions.

Significant strengthening of the patent right protection and securing “data exclusivity" for medical products in these countries will adversely affect the fulfilment of the commitments undertaken by the European Commission within the framework of the "Action Plan for combating HIV/AIDS in the European Union and neighbouring countries, (2009-2013)”.  Moreover, the tightening of the intellectual property regime is not only non-mandatory according to the WTO TRIPS Agreement and incompliant with the spirit of the Doha Declaration, but also directly contradicts with measures aimed at ensuring the right to life and health undertaken by the Governments and international organizations, including the Global Fund to combat HIV/AIDS, Tuberculosis and Malaria in Georgia, Moldova and Ukraine.

At the same time, exclusion of the above-mentioned provisions from the Agreements will not contradict with the commitments reflected in the key documents in the sphere of intellectual property; alternately it will help the European Union and the countries signing the Agreement to fulfil their obligations imposed on them by international acts and treaties to ensure the fundamental rights of citizens, such as the right to life, health and universal acccess to treatment - including access to anti-retrovirals.

 

Sincerely yours,

V.O. Zhovtyak,

President, Eastern European and Central Asian Union of PLWH

 

G.S. Vergus,

Coordinator, International Treatment Preparedness Coalition in Eastern Europe and Central Asia

 

S.E. Votyagov,

Executive Director, Eurasian Harm Reduction Network

 

Collection of signatures for the petition, both individual and collective, continueson change.org

Z.Shabarova, 

AIDS Healthcare Foundation

 

We ask you to send the answer, as soon as possible, to following address:

"Eastern European and Central Asian Union of PLWH "

Secretariat ECUO PLWH:

87"A", Mezhyhirska St., | Kyiv | Ukraine 04080

e-mail: alexandravolgina@ecuo.org 

Annex 1: Rationale for the exclusion of three TRIPS-plus provisions of the Association Agreements between the European Union and the Republic of Moldova, Georgia and Ukraine(with the last negotiations currently stopped).

As of 31 December 2011 there were registered 3,033 cases of HIV infection in Georgia. The annual number of reported cases has increased from about a hundred in 2000-2003 to more than 250 since 2006.

In Moldova, according to expert estimates, in 2012 the prevalence of HIV infection on the right bank of the Dniester River was 0.44 % and 1.31 % — on the left bank. The number of people living with HIV in 2012 was estimated at 14,528 individuals. The need of ARV treatment was estimated at 5,683 persons.

In Ukraine, the experts estimate that about 3.5 million Ukrainians are living with hepatitis, whereas only this year the Government approved the State program of treatment funding and the cheapest treatment is available at approximately USD 22,000 per patient per year. The HIV epidemic in Ukraine is one of the worst in Eastern Europe and the Commonwealth of Independent States, and together with the HIV epidemic in Russia it is considered to be the fastest growing HIV epidemic in the world. In early 2012, the number of people living with HIV in Ukraine was 230,000, while the coverage of antiretroviral therapy in 2012 amounted to 22.0% of the estimated number of patients who needed it.

According to the international experts, the only effective mechanism for reducing essential drug prices is the competition of cheap generic drugs with original/branded medicines. Pharmaceutical companies that supply original/branded drugs to Georgia, Moldova and Ukraine prevent or delay the beginning of such competition from the part of manufacturers of generic drugs by obtaining patents for respective drug or their minor modifications, the utilization of “data exclusivity” in relation to the medicinal product and application of customs procedures and criminal prosecution.

International experts presume that the patents on antiretroviral drugs (ARVs ) can lead to a significant increase in prices for ARVs, rise government expenditures and, respectively, shrink of programs to combat HIV/AIDS, tuberculosis, hepatitis in Georgia, Moldova and Ukraine.

Draft EU Association Agreements with Georgia and Moldova, unfortunately, are not yet available except for the draft Association Agreement with Ukraine. However, based on the historical evidence of previous free trade agreements that the European Union has already concluded and the draft Association Agreement between Ukraine and the European Union, the agreements may provide for the establishment or significant strengthening of the protection regime for patent rights and “data exclusivity” for drugs compared with the obligations undertaken by Georgia, Moldova and Ukraine within the framework of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). In the world practice, such provisions of free trade agreements are called TRIPS-plus provisions and have a negative impact on the access to medicines in the medium income level countries.

UNAIDS warns the countries against the use of TRIPS-plus, since they can become an insurmountable barrier to the universal access the treatment.

It should be noted that in the European Union, the issue of correlation between access to medicines and protection of patent rights has been raised repeatedly. Thus, in the European Parliament Resolution of 12 July 2007 on the TRIPS Agreement and access to medicines addressed to the Council of the European Union, the European Parliament:

"... 11. Calls on the Council [EU] to fulfil its commitments undertaken under the Doha Declaration and to restrict the mandate of the Commission in order to prevent it from promoting in the course of negotiations the TRIPS-plus provisions relating to medicinal products affecting public health and access to medicines, as the data exclusivity, patent term extension and limitation of grounds for compulsory licenses under negotiation of ... future bilateral and regional agreements with developing countries."

Furthermore, according to the EU estimates on competition in the pharmaceutical sector conducted in 2008 by the EU Commission to investigate possible anti-competitive conditions in the pharmaceutical sector, "release of unpatentable [generic] drugs takes too much time. On average the consumers are waiting for 7 months till the cheaper generic drugs become available, once the patents for branded medicinal products expire. One of the reasons for this is the fact that the pharmaceutical companies employ various methods to extend the commercial life of their medicinal products. When the brands have to compete with generics, the prices drop and more patients can be treated. Price reduction can be quite substantial; as an example, we estimate that on one drug the additional savings of 20% would be possible if the generic version [of the medicinal product] would be available immediately after the patent for the original drug has expired."

As a result of the investigation, "The Commission will examine the sector more closely and, if necessary, it will prosecute certain companies for the violation of the competition law. Also, the EU countries will be urged to:

implement the mechanisms that significantly accelerate the process of approval of unpatentable [generic] drugs, in particular, immediate / automatic pricing;

take measures to support fast entrance of generic drugs to the market and to improve price competition".

We would like to reiterate once again that the absence of the above provisions will not contradict, in any way, with the obligations within the framework of the WTO agreements and the key documents in the sphere of intellectual property.  Moreover, the tightening of the intellectual property regime is not only non-mandatory in line with the WTO TRIPS Agreement and   incompliant with the spirit of the Doha Declaration, but also directly contradicts the measures aimed at ensuring the right to life and health undertaken by the Governments and international organizations, including the Global Fund to combat HIV/AIDS, Tuberculosis and Malaria in Georgia, Moldova and Ukraine.

It should also be noted that the exclusion of these clauses from the Agreement will have a positive impact on the status of access to medicines not only in the sphere of HIV infection, but also in the sphere of treatment of other diseases, including those that are the most socially dangerous. For example, the exclusion of these clauses will provide better access to modern drugs to treat MDR (multidrug-resistant) and XDR (extensively drug resistant) Tuberculosis which acknowledged as one of the main public health threats for the entire Eastern European region.  The exclusion of these clauses will result in improvements in the public health, which in its turn will contribute to the implementation of commitments undertaken by the European Commission within the framework of the "Action Plan for combating HIV/AIDS in the European Union and neighbouring countries (2009-2013)" ("Plan"), which clearly states: "Affordable drugs necessary to ensure universal access across Europe".

 

 

The ЕU has provided the Global Fund with EUR 872,000,000 since 2002 within the framework of the EU-India FTA negotiations and access to medicines; Questions and answers http://trade.ec.europa.eu/doclib/docs/2010/may/tradoc_146191.pdf

Georgia Country Progress Report on HIV/AIDS, January 2010 – December 2011, p. 14, http://www.unaids.org/en/regionscountries/countries/georgia/

Republic of Moldova Progress Report on HIV/AIDS, January 2010 – December 2011, p. 11,http://www.unaids.org/en/dataanalysis/knowyourresponse/countryprogressreports/2012countries/ce_MD_Narrative_Report[1].pdf

Report of the organisation “Doctors Without Borders” (MSF) Untangling the Web of ARV Price Reductions, 16thedition, July 2013http://msfaccess.org/sites/default/files/AIDS_Report_UTW16_ENG_2013.pdfpage 2.

 As a rule, the provisions of the free trade agreements are a part of the association agreements.

 See draft Association Agreement between Ukraine and the EU, officially published on the government portal of Ukraine on 30 August 2013http://www.kmu.gov.ua/control/uk/publish/article?art_id=246581344 and an unofficial text of the document in English is available athttp://glavcom.ua/pub/2012_11_19_EU_Ukraine_Association_Agreement_English.pdf

 http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf).

Paragraphs 8, 9, 11 of the Resolution of the European Parliament of 12 June 2007 regarding TRIPS Agreement and affordability of medicinal productshttp://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0353+0+DOC+XML+V0//EN

          Summary of the EU Inquiry for citizens on the competition in the pharmaceutical markethttp://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/citizens_summary.pdf

          Summary of the EU Inquiry for citizens on the competition in the pharmaceutical market http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/citizens_summary.pdf

The ЕU has provided the Global Fund with EUR 872,000,000 since 2002 within the framework of the EU-India FTA negotiations and access to medicines; Questions and answers http://trade.ec.europa.eu/doclib/docs/2010/may/tradoc_146191.pdf

 http://europa.eu/legislation_summaries/public_health/threats_to_health/sp0016_en.htm



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