[Ip-health] Mercosur negotiations & Policy incoherence: the Commission ignores EU Member States’ doubts on pharmaceutical patents.
david at davidhammerstein.org
david at davidhammerstein.org
Wed Dec 6 10:38:09 PST 2017
Brussels: Dec 5-2017
Mercosur negotiations & Policy incoherence: the Commission ignores EU Member States’ doubts on pharmaceutical patents.
Mercosur trade agreement negotiations threaten to raise prices on lifesaving medicines.
This week, the EU will finish trade negotiations with Mercosur, a union of Southern American countries including Brazil, Argentina, Uruguay and Paraguay. DG Trade is demanding on behalf of the Commission, the most stringent restrictions on intellectual property (IP) rights, exporting its own current IP rules, despite internal criticism.[i] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_edn1> Longer intellectual property protection will delay competition for generic medicines producers, effectively leading to higher medicine prices for people in South America.[ii] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_edn2> A recent briefing document from Médecins Sans Frontières says: ‘If these IP proposals are included in the final agreement, access to essential medicines will be restricted for millions of people across Mercosur countries. Furthermore, the capacity of these countries to promote global price reductions will be seriously undermined.’[iii] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_edn3>
What is most concerning is that the European Commission is well aware of the negative effects that harmful IP provisions such as Market Exclusivity, Data Exclusivity (DE) and Supplementary Protection Certificates (SPCs) may have on the affordability of medicines and the sustainability of health systems. European member states have asked the Commission to study and review the existing incentive mechanisms in the pharmaceutical sector, including the very same harmful IP provisions it is exporting to Mercosur, out of a concern that they lead to unaffordable medicines in Europe.[iv] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_edn4>
Sophie Bloemen, Commons Network: “Over the past years, civil society and payers organizations have repeatedly called on governments not to extend harmful IP provisions protection on medicines beyond standard patent terms. It appears, however, that the discussions taking place in Europe and the concerns around the negative effects of additional harmful IP provisions are not extended to Mercosur countries.’’
Besides additional IP protections the EU intends to lock in its infringement policy in the Free Trade Agreement. This controversial policy allows the EU to seize legally produced and traded generic medicines or their ingredients that pass in transit in Europe. This regulation, which is already in force, would damage the trade in safe and affordable generic medicines between Asia and South America, as already happened in 2008 and 2009, when at least 19 shipments of legal generic medicines were wrongfully seized while in transit in Europe.
What has been negotiated behind closed doors will have an impact on millions. To make matters worse, by forcing these extra protections on Mercosur, the EU is undermining potential efforts by its Member States to revise the pharmaceutical system in order to ensure affordable access for their populations and to guarantee the sustainability of our health systems. The Mercosur Free Trade Agreements risks having an indirect impact on access to medicines and the sustainability of health systems in Europe as it locks in current standards.[v] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_edn5> As member states are asking for an open and factual debate about balancing private and public health interests in the pharmaceutical sector, including a revision of the current incentives and protections.
The Eu-Mercosur FTA would be a significant blow these legitimate requests and a demonstration of how out of touch the Commission is with reality in and the diversity of opinions among its member states. For the sake of the access to medicines in South America and the role of those countries in promoting global price reductions, The EU Mercosur FTA must not include any reference to data exclusivity, SPCs, market exclusivity and border enforcement measures. By removing such measures European negotiators will also ensure cohesion and strengthening of ongoing efforts by member states to reduce drug prices in Europe.
It is crucial that EU trade policy neither weakens the ability of the EU, its member states or partner countries not to impede efforts to promote universal health coverage and access to affordable medicines. This is why it is regrettable that the agreement with Mercosur countries fails to recognise affordable access to medicines as a key global public health concern, which also contradicts the SDG health objectives Trade agreements should be in line with.
For extra information, please contact Sophie Bloemen:
Sophie at commonsnetwork.eu <mailto:Sophie at commonsnetwork.eu>
[i] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_ednref1> Letter to chief negotiators EU & Mercosur, HAI et all, 1 Dec. 2017 : http://haiweb.org/wp-content/uploads/2017/12/Joint-letter-on-EU-Mercosur-Trade-Negotiations.pdf <http://haiweb.org/wp-content/uploads/2017/12/Joint-letter-on-EU-Mercosur-Trade-Negotiations.pdf>
[ii] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_ednref2> An impact analysis (Fiocruz, ENSP, 2017) of TRIPS-plus measures proposed by the EU on public purchases and domestic production of HIV and Hepatitis C medicines in Brazil demonstrates that, if Brazil were to adopt data exclusivity and supplementary patent protection (the latter in case of administrative delays) as suggested by the EU, public health expenditures for HIV-Aids and Hepatitis C would increase by the equivalent to c. EUR 350 million per year. There is no reason to expect any different impact in the other three Mercosur countries. Available at: http://www.ensp.fiocruz.br/portal-ep/informe/site/arquivos/anexos/01abfe4ae54f0d6efd743fe6eea6abe259bdb702.PDF <http://www.ensp.fiocruz.br/portal-ep/informe/site/arquivos/anexos/01abfe4ae54f0d6efd743fe6eea6abe259bdb702.PDF>
[iii] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_ednref3> MSF Trading Away Health in the EU - Mercosur Trade Agreement, September 2017.
[iv] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_ednref4> Council Conclusions (June 2016) on strengthening the balance in the pharmaceutical systems in the EU and its Member States. <http://www.consilium.europa.eu/en/press/press-releases/2016/06/17/epsco-%20conclusions-balance-pharmaceutical-system/>
[v] <applewebdata://20E5259D-C1C3-42F7-BA06-645AC7ADAAE2#_ednref5> HAI, Commons Network and Public Citizen: TTIP and Affordable Medicines: How TTIP may obstruct progress towards sustainable medicines (2016). Available at: http://commonsnetwork.eu/wp-content/uploads/2016/10/TTIP-and-Affordable-Medicines.pdf <http://commonsnetwork.eu/wp-content/uploads/2016/10/TTIP-and-Affordable-Medicines.pdf>
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