Access to Medicines

Joint statement on Innovative Medicines Initiative launched

The European Respiratory Society (ERS), an EPHA member, has coordinated and endorsed the Joint Statement on Innovative Medicines, which was launched on 17 October 2007.
The ERS has coordinated an official endorsement from ten medical societies and organisations expressing support for the Innovative Medicines Initiative, which will represent a unique opportunity for collaboration between public and private research groups at the EU-level. ERS believes that this opportunity, if seized now, (...)

Ensuring independent medicines information in Europe

Health Action International (HAI), an EPHA member, organised an open seminar entitled Ensuring independent medicines information in Europe on 12 October 2007, in Brussels.
The seminar was an interactive event on the issue of medicinal information in Europe, thereby relaunching the debate on Direct-To-Consumer-Advertising (DTCA).
On this occasion, HAI invited different speakers such as representatives of the European Consumers’ Organisation (BEUC), Association Internationale de la (...)

EPHA Briefing note on TRIPS, access to medicines and the Novartis case

On January 2006 the Indian authorities rejected an application to patent filed by Novartis on the grounds that the drug was a new form of an old drug, and therefore was not patentable under Indian law.
In other countries where Novartis has a patent, the drug is sold at $2,600 per patient per month. In India, generic versions of this drug are available for less than $200 per patient per month.
Novartis is therefore trying to have the patent decision overturned so that it can sell the drug (...)

Albanian Association for Prevention and Rehabilitation from AIDS and Drugs

The Albanian Association for Prevention and Rehabilitation from AIDS and Drugs (APRAD) has been very active in following harm reduction strategies in reducing risk of HIV or STD acquisition or transmission.
APRAD publish very informative monthly Newsletters, which offer an interesting insights into its work. The Newsletter follows the APRAD Centre which offer diverse services such as -
Training session for at-risk and vulnerable groups
Condom distribution and clean syringes
Psychosocial (...)

Action for Global health - a European NGO network

Officially launched on the 27th October 2006, this network gathers 15 European NGOs working on health and development issues. EPHA is one of the Brussels-based partners.
Background information about the project
Although not comprehensive, the Health Millenium Development Goals (MDGs) continue to offer the best catalyst to push for increased action to improve health in developing countries.
As commitments signed by donor countries, they are an effective advocacy tool. With half of the (...)

Health Action International 25th Anniversary Conference on people-centered medicines

On the 26 and 27 October, Health Action International - an EPHA member - celebrates its 25th Anniversary with a special Conference on "Pills, Politics and Practice: demanding people-centred medicines policy in the 21st century".
The conference will explore HAI’s core areas of work: 1. Access to essential medicines 2. Rational use of medicines 3. Democratisation of medicines policy
During the conference, will be released a booklet about HAI past achievements and examples of best practices. (...)

Supporting the International Drug Purchase Facility

AIDES is seeking for support on a declaration about new fundraising schemes to support access to medicines for AIDS, Tuberculosis and Malaria.
The governments of Brasil, Chile, France, and Norway among others have become strong supporters of both:
implementing innovative fundraising mechanisms to support worldwide development efforts (notably through a small tax on airfares)
setting up a new International Drug Purchase Facility - dedicated to improve long-term and cost-efficient access (...)

An extra grant for the TB Alliance to fight against tuberculosis

The Global Alliance for TB Drug Development (’TB Alliance’) announced in late May that it is receiving $104 million from the Bill & Melinda Gates Foundation to advance a pipeline of new TB drugs over the next five years.
This is the second grant received by the TB Alliance from the Gates Foundation. The grant quadruples the foundation’s initial support.
The funding will serve to pursue pre-clinical trials and continue engagement with policy-makers, TB drug providers, and advocates to (...)

EMEA guidelines on pharmacovigilance for paediatric medicines - EFA’s comments

The European Federation of Allergies and Airways Diseases Patients Associations (EFA) in cooperation with the International Primary Care Respiratory Group (IPCRG) submitted comments to the European Medicines Agency (EMEA) draft Guidelines on conduct of pharmacovigilance for medicines used by the paediatric population.
The EMEA launched such a consultation in order to prepare the implementation of the proposed EU paediatric medicines regulation.
EFA and IPCRG stressed the role of patients (...)

Fighting for Breath - a report on living with severe asthma

EPHA Member, the European Federation of Allergy and Airways Diseases Patients’ Association (EFA) launched the results of the survey "Fighting for Breath: a European patient perspective on severe asthma" at the European Respiratory Society (ERS) Congress in September 2005.
Up until now, no pan-European survey by patients for patients has reported the real life experiences of what people living with severe asthma undergo every day. According to the report, "millions of people across (...)

PGEU response to consultation on EMEA road-map

The Pharmaceutical Group of the EU (PGEU), an EPHA member, has submitted a response to the consultation on the European Agency for the Evaluation of Medicinal Products (EMEA) road-map to 2010 document.
Please find below PGEU’s response.
Discussion Paper EMA Road Map to 2010 - Executive Summary
EMEA’s press release, 14 April 2004

Natural medicine in an united Europe - quo vadis? (2004)

The Association of Natural Medicine in Europe (ANME) held a symposium on the specific needs of complementary and alternative medicine (CAM) in the EU on 13 November 2004 in Frankfurt/M., Germany.
While discussions on health care costs and reimbursement structures are going on, while regulations on pharmaceuticals are being released, some of them threatening the test certificate of natural drugs, CAM is neglected in the debate on health policy.
But if health systems are to remain affordable (...)

BMA’s letter to UK delegates to Cancun

On 28 August 2003 the British Medical Association (BMA) sent a letter to the UK delegation to the WTO Cancun Ministerial (see attached document).
On the same topic, Dr Edwin Borman (Chairman of the BMA International Committee) participated in the online web chat with Europe’s chief trade negotiator Pascal Lamy on Thursday 4th September.
The BMA submitted the following questions to the Trade Commissioner :
1. We note that the Chairman’s Statement accompanying the Decision of 30 August (...)

US and EU Disagree on AIDS Fund

US and EU are the two world’s largest donors to fight AIDS in Africa. However their approaches differ substantially.
Recent comments of Wanjiku Kamau (Dutch AIDS Fonds) to the european press picture the situation from the NGO point of view.
Wanjiku Kamau, Dutch AIDS Fonds.

EU Development Days

On 13 - 17 November 2006, the European Commission organised the first edition of the European Development Days. The event aimed at enhancing public awareness about development cooperation and strengthening the effectiveness of the European Union’s development assistance.
The 2007 edition was particularly focused on Africa and the need for Europe to deliver more, better and faster aid in view of the implementation of the Millennium Development Goals (MDGs).
Within the Development Days, the (...)

Conference ’Priority Medicines for the Citizens of Europe’

The Dutch presidency organised a high-level conference and dinner on 18th November 2004 from 15.00-22.00h in The Hague.
The objective of the conference was to present a R&D agenda for the research and development of medicines, vaccines and biologicals which meet the real health needs of European citizens.
The conference aimed to identify gaps in the development of pharmaceuticals, introducing a solid methodology for this purpose, ways to reduce the number of these gaps and to establish (...)

EU funds research project on drug resistance

The EU announced on the 28th June 2004 a contribution of €9 million to the “Vigilance against Viral Resistance” (VIRGIL) project.
This project intends to start by studying viral hepatitis and influenza, and then broadening to other viruses.
The network will be based on research and technological platforms to monitor existing, and anticipate future, drug resistance.
The VIRGIL project is coordinated by Lyon’s INSERM research centre and gathers 55 key European field experts from (...)

Conference: Financing the Millenium Development Goals

The Socialist Group of MEPs is organising a conference on ’Financing the Millennium Development Goals’ to be held on Thursday 15th April 2004 in the European Parliament, Brussels.
The conference will explore progress towards the MDGs, where we are going wrong in our financing of the Goals, and what signals we need to send to governments in order to improve both the levels and delivery of financing and to achieve our aims.
The Conference will focus on three main themes:
Goal 6: Combating (...)

EU-African clinical trials partnership programme

On 1 September 2003, Science & Research Commissioner Philippe Busquin presented the Europe-Developing Countries Clinical Trials Partnership (EDCTP) to 46 African Health ministers at the WHO conference in Johannesburg.
This 600 million euro programme was launched in 2002, bringing together the EU Member States (plus Norway), developing countries, the private sector and international foundations.
It aims to combat HIV/AIDS, malaria and tuberculosis by facilitating and accelerating clinical (...)

EU to Donate "a Substantial Contribution" to the Global Fund to fight AIDS, Tuberculosis and Malaria

A draft statement was adopted at the Thessaloniki Summit, carefully stating that the Global Fund to fight AIDS, Tuberculosis and Malaria would receive a "substantial contribution, on a long-term basis" from the EU.
The US has already committed to contribute with USD 1 Billion by 2004.
Presidency Conclusions of the Thessaloniki Summit

Seminar on "Global Substantive Health Issues". 5-6 June 2008

The Economic and Social Research Council (ESRC) will hold a seminar on "Global Substantive Health Issues" on 5 and 6 June 2008. The seminar will take place at the University of Warwick.
Links between health and human rights have historically been two-fold. First, in terms of access to health care. Second, where human rights abuses, such as torture, have impacted upon health (Mann et al 1999a).
More recently, wider public health issues are also being addressed using rights-based approaches. (...)

European Risk Management Strategy on medicines launched

At their meeting in Funchal (Portugal) held in November 2007 the Heads of Medicines Agencies (HMA)and the European Medicines Agency (EMEA) adopted a two-year work programme to enact a European Risk Management Strategy (ERMS) on medicines.
The European Risk Management Strategy aims to conduct pharmacovigilance through measures allowing the early detection, assessment, minimisation and communication of risks of medicines in Europe during their life cycle.
For the work programme 2008-2009 the (...)

Corruption and health - the latest up-to-date Transparency International report

Transparency International - NGO devoted to combat corruption and increase transparency - has focused its 2006 global corruption report on corruption in the health sector.
Main findings Transparency International looked at three sectors: healthcare, pharmaceutical companies and HIV/AIDS fight.
They point out the causes of corruption (imbalance of information, uncertainty of health markets, complexity of health systems) and highlight the following patterns:
1. Embezzlement and theft from (...)

Launch of the UN Millennium Project report

On 17 January 2005, the Millennium Project - an advisory body to the UN that brings together 265 of the world’s leading development experts - published a report "Investing in Development".
The report proposes a package of specific cost-effective measures that would allow to cut extreme poverty by half and radically improve the lives of at least one billion people in the developing countries by 2015.
In the field of health, the report highlights the following challenges:
Child and maternal (...)

Public health success story over measles

The World Health Organisation (WHO) and the United Nations Children’s Fund (UNICEF) announced that measles deaths were halved between 1999 and 2004 thanks to a global immunization plan involving all actors and political leadership.
According to the WHO latest data, 454 000 people (vast majority of them are children) died of measles in 2004 compared to 871 000 in 1999 - a 48% plunge.
The WHO-UNICEF Global Plan’s goal is now to reduce the mortality by 90% by 2010, complying therefore (...)

Opportunity for NGOs to participate in a UN General Assembly on HIV/AIDS

In order to review the implementation of the United Nations (UN) 2001 Declaration on Commitment on HIV/AIDS, the United Nations will organise a follow-up meeting due to take place in New York from 31 May - 2 June 2006. They plan to involve all stakeholders, including civil society organisations.
It is meant to review progress achieved in realising the commitments set out in the 2001 Declaration and to renew political commitment.
It will involve all sectors of the international community, (...)

Second Global Plan brings the fight against TB to a new level

The Global Plan to Stop TB 2006-2015, Actions for Life was launched at the World Economic Forum in Davos, Switzerland on 27 January 2006.
With 9 million cases and 2 million deaths every year worldwide, tuberculosis ranks among the leading infectious diseases with an incidence rate of 1% each year.
The Global Plan sets out a 10-year agenda for reducing TB incidence in line with Millennium Development Goals and for halving, by 2015, TB prevalence and deaths compared with 1990 levels. (...)

Newborn health receives major financial support

The Bill and Melinda Gates Foundation announced the allocation of $ 84.3 million to help prevent newborn illness and death in 18 developing countries.
Almost 99% of the death cases occur in the developing countries.
The death of millions of children could be prevented by improving the access to antibiotics, sterile blades and clean childbirth kits.
The grant will be used for two initiatives:
Save the children for newborn health projects in 18 developing countries ($60 million)
Path to (...)

New joint guidelines on health services and HIV/AIDS

Experts brought together by the International Labour Organization (ILO) and the World Health Organization (WHO) have agreed to joint guidelines on health services and HIV/AIDS. The new guidelines are a move to help protect the safety and health of workers that deal with HIV/AIDS and they are designed to ’ensure a functioning and healthy medical work force’.
The background for the guidlines is that while access to healthcare is a basic human right, provision of healthcare remains (...)

New resources on social medicine

A new Social Medicine Portal has been established to promote the understanding and practice of social medicine.
Hosted by the US-based Albert Einstein College of Medicine, the site contains a useful historical introduction to some of the key principles of social medicine:
Social and economic conditions profoundly impact health, disease and the practice of medicine.
The health of the population is a matter of social concern.
Society should promote health through both individual and (...)

EPHA briefing note on the Final report on EU patient mobility

The High Reflection Process examining the issue of patient mobility releases its final report and recommendations
The High Reflection Process, much criticised for its lack of transparency, released its report about the consequences of patients seeking treatment in other Member States (MS).
For the benefit of our members EPHA produced a briefing paper in October 2003, which provided a simplified overview of the process thus far.
In response to this final report, EPHA has produced a (...)

Access to maternity services in developing countries key to preventing deaths

A report by independent consultants of the US based Futures Group International and published on the Tropical Medicine & International Health journal states that access to maternity health services is one of two key indicators for maternal mortality in developing countries.
For full BMA’s article on this issue, click here.

EPHA Consultation Response on "Information to Patients", April 2008

EPHA has responded to the European Commission’s (Directorate General on Enterprise and Industry) public consultation on "Information to Patients" on medicinal products.
Background
The provision of information to patients has been under discussion at European level for a number of years. The report on current practices with regard to the provision of information to patients on medicinal products was released in December 2007 as a communication to the European Parliament and Council from (...)

**update** Big pharma groups raided in EU antitrust probe

This article is an update regarding the renewal of patents of pharmaceuticals companies in the infectious disease market.
The two biggest sectors for drugs targeting infectious disease, antibiotics and antifungals, have seen major decline over 2005-2006. Imminent patent expiries of major products urge pharmaceutical companies to decide what sort of presence they should maintain in the market.
Some experts claim that this would have a positive effect on the market since certain (...)

WHO reviews innovation and intellectual property issues

Negotiations for a new approach to improving access to essential medicines suspended as consensus proves illusive.

**Updated** The European Pharmaceutical Forum: discussing provision of information to patients on medicinal products

This article has been updated with a recent press release signed by Health Action International (HAI), the International Society of Drug Bulletins (ISDB), and the Medicines in Europe Forum (MiEF) (attached).
In order to re-launch the debate on Pharmaceutical issues and on information to patients, the European Commission has set up the Pharmaceutical Forum, which proves to be very unbalanced and non-transparent.
The Pharmaceutical Forum was jointly established by Vice President Verheugen (...)

Indian Court rejects Novartis challenge to generics

The high court in Madras has rejected the Novartis challenge to Indian Patent laws. Campaigners for access to essential medicines have welcomed the courts ruling, having feared that any other judgement would have jeopardised the large scale generic drug manufacturing industry in India.
The company had claimed that Indian patent law did not comply with the country’s Constitution following the rejection of their patent application for a cancer drug "Glevic".
The full text of the judgement (...)

European Parliament tells Commission not to prevent access to medicines in developing countries

The European Parliament is insisting that the Council and the Commission do more to ensure access to essential medicines in developing countries. The Parliament has refused to ratify the WTO protocol on intellectual property rights until it has guarantees from the Council and the Commission that they will fully support access to essential medicines.
On 17 July 2007 MEPs stepped up a campaign to make cheap medicines available to the world’s poorest countries by delaying an international (...)

***Updated*** A European database on medicinal products: EudraPharm

EudraPharm is the name of the public database launched by the European Medicines Agency (EMEA) to facilitate access to information about medicines available in the European Union. This article was updated to include information about new languages.
The EudraPharm database is designed to give on-line access to information about all medicinal products for human or veterinary use that have been authorised in the European Union (EU).
It includes the summary of product characteristics, package (...)

*UPDATED* Access to medicines: generic medicines threatened in India

*UPDATED with latest developments in the Novartis case and mobilisation at EU level.*
The international humanitarian NGO Medecins Sans Frontieres (MSF) urges the European Union institutions to support the Indian government in a legal fight against a pharmaceutical company over patented medicines. MSF calls for support for its petition to help protect access to affordable medicines, and urges the Swiss pharmaceutical company Novartis to drop its case against the Indian Government.
The (...)

EMEA consults stakeholders on the readability of the labelling and package leaflet of medicines

The European Medicines Evaluation Agency issued a consultation in November 2006 to review the draft “Guideline on the readability of the label and package leaflet of medicinal products for human use”.
European Directive 2004/27/EC, which modified Directive 2001/83/EC, introduced important requirements to medicines’ packaging, in order to minimize medication errors and ensure the rational use of drugs.
The EMEA is now in the process of implementing the requirements set up in the (...)

**Updated**EMEA/CHMO working group with patients’ organisations, 2006

2006 had four meetings of the EMEA/CHMP Working Group with Patients’ & Consumers’ Organisations in London, of which EPHA is an active member. Background documents can be found at the EMEA Working group with patient and consumer organisation’s website
The EMEA is still eager to receive new applications from organisations wishing to participate in its activities, specially those organisations representing patients of cardiovascular diseases and those working on paediatric medicines. (...)

MSF Fact Sheet on Children and HIV/AIDS

The Medecins Sans Frontieres (MSF) Access to Essential Medicines campaign have created a 4-page Fact Sheet on Children and HIV/AIDS.
The publication urges players in HIV/AIDS treatment field to better facilitate access for children to antiretroviral therapy.
MSF makes a number of recommendations, specifically:
WHO and UNICEF should develop a clear strategy to ensure that greater numbers of children receive antiretrovirals;
Pharmaceutical companies should facilitate access for children to (...)

Marketing Practices and Accountability of Drug Companies Questioned

The Consumers International lobby group accused drugmakers of unscrupulous marketing practices by misleading physicians of a drug’s effectiveness and convincing consumers of the drug’s importance. The study revealed a "shocking" lack of transparency in the marketing practices of the world’s top-twenty drug companies.
In 2005 total global pharmaceutical sales grew 7 per cent at constant exchange rates, to $602 bn (€480 bn). The report identified an annual marketing spend of $60bn (€47bn). (...)

Outcomes of the World Health Asembly - Intergovernmental Working Group on Essential Health Research and IPRs

EPHA attended Médecins Sans Frontières debriefing session on the outcomes of May’s World Health Asembly (WHA). The session focussed on the WHA’s resolution on essential health research and intellectual property rights (IPRs) - see the attached report on WHA Towards a Global Strategy. It was also an opportunity to discuss the key issues and opportunities raised by the newly created intergovernmental working group.
Background Information by MSF The Commission on Intellectual Property and (...)

WHO intergovernmental working group on public health and intellectual property

This article describes the current status of the new intergovernmental working group on public health and intellectual property, as well as the history behind its establishment.
Setting up an intergovernmental working group
An intergovernmental working group on public health and intellectual property, which the World Health Assembly said in May should be set up “immediately”, is scheduled to meet for the first time in December in Geneva.
According to Intellectual Property Watch, (...)

*UPDATED* World Intellectual Property Day: Governments should not ignore WHO independent Commission report

*UPDATED with the results of the World Health Assembly, May 2006.* World Intellectual Property Day, held on 26 April, was marked by Médecins Sans Frontières (MSF) urging governments not to ignore the conclusions of World Health Organisation commissioned report on intellectual property and public health.
The Report of the Commission on Intellectual Property, Innovation and Public Health(CIPIH) entitled "Public health: innovation and intellectual property rights" was published earlier in (...)

**UPDATED** Research and Development in global health

UPDATED with the results of the World Health Assembly. In May 2006, the World Health Assembly adopted a resolution on "Global Framework on Essential Health Research and Development", which aims to address the priority health needs of people living with HIV/AIDS and other diseases, especially those in poor countries, and to develop improved safe and affordable health products such as HIV vaccines.
NGO campaigning activities
In order to support the upcoming 2006 World Health Assembly (...)

UPDATED - Call for support: WHO draft resolution on health Research & Development

**Updated: the resolution will be discussed at the World Health Assembly in May 2006** On November 16 2005, the Republic of Kenya asked the World Health Organisation (WHO) to discuss a proposed resolution on a "Global Framework on Essential Health Research and Development" at the 23-28 January meeting of the WHO’s Executive Board.
The resolution is a really strategic and important opportunity to get support for a new global framework for health Research & Development which addresses the (...)

WTO amends the TRIPS agreeement on access to medicines

WTO members on 6 December 2005 approved changes to the TRIPS intellectual property agreement, making permanent a decision on patents and public health originally adopted in 2003.
The World Trade Organisation set up a waiver in August 2003, the goal of which was to make it easier for poorer countries to obtain cheaper generic versions of patented medicines, by setting aside a provision of the TRIPS Agreement (article 31f) that could hinder exports of pharmaceuticals manufactured under (...)

Health Action International on European medicines’ policy

Health Action International-Europe (HAI), an EPHA member, has recently published three new position papers on key issues affecting European medicines’ policy.
"Running on empty: Medicines’ production and the absence of innovation" lays out HAI’s view that the pharmaceutical industry does not and will not produce medicines geared to public need - i.e. geared to priority conditions, at affordable prices and of genuine therapeutic advance. It concludes by urging policy-makers to look for, and (...)

Petition to WHO on research and development of medicines

On 24 February 2005, 162 non-governmental organisations, academics and politicians issued an open letter urging the World Health Organisation to evaluate the draft Medical Research and Development Treaty that has been drawn up over the past two years by a group of economists, scientists and public health experts
Existing trade agreements designed to bolster medical R&D investments focus nearly exclusively on stronger intellectual property rights and higher drug prices. This approach (...)

World Economic Forum debates HIV/AIDS epidemic

The 2005 annual meeting of the World Economic Forum (WEF) took place on 26-30 January in Davos (Switzerland). One of the central themes of this year’s meeting was the fight against the AIDS epidemic.
Today, about 40 million people are living with AIDS. About half live in Africa, where there are over 8,000 new infections each day.
In his opening address, UK Prime Minister Tony Blair appealed for more aid for Africa and committed the UK to provide nearly one sixth of a World Health (...)

WHO launchs new report on Priority Medicines for Europe and the World

The World Health Organization (WHO) released a report which recommends ways in which pharmaceutical research and innovation can best address health needs and emerging threats in Europe and the world.
Priority Medicines for Europe and the World, commissioned by the Dutch Government as current president of the European Union (EU), identifies a priority list of medicines for Europe and the rest of the world, taking into account Europe’s ageing population, the increasing burden of (...)

Commission proposes regulation to allow export of generic medicines to poor countries

The European Commission has proposed a Regulation to allow manufacturers of generic pharmaceuticals to produce patented medicines for export to “countries in need” without sufficient capacity to produce them.
The Regulation would implement within the EU the WTO decision of 30th August 2003 under which national authorities can grant “compulsory licences” for such production if certain conditions are fulfilled. One requirement is that the destination country must have (...)

Malaria vaccine developments

An new vaccine in development has shown positive results in paediatric trials against the malaria that is found in the developing world (RTS,S/ASO2A).
The study, published in the "The Lancet", shows the results of a vaccine, developed by GlaxoSmithkline (GSK) Biologics and tested amongst children between one and four years old for a period of six months in Mozambique.
This vaccine was first tested in adults in Belgium, Kenya, The Gambia, and the US. It has since been tested in children in (...)

WHO welcomes Canada’s proposed legislation on access to medicines

The World Health Organization (WHO) welcomed Canada’s recent tabling of new legislation which, if passed, would allow drug manufacturers to export low-cost, quality medicines to the world’s poorest countries.
Canada is the first country to propose changes to its patent legislation to put into practice a decision made by World Trade Organization (WTO) members on 30 August 2003, which allows exports of generic medicines to countries with insufficient pharmaceutical manufacturing.
The (...)

Pharmaceuticals review - Parliamentary vote - November 2003

MEPS vote against advertising but ask for clarity on the provision of information
In early November 2003 the Parliament’s Environment Committee began to discuss its response to the review of the Pharmaceutical’s legislation.
There are three proposals under consideration:
Regulation 2309/3 concerns the provision of a legislative framework for medicinal products.
2 Directives: 2001/83 on human medicine, and 2001/82 concerning vetinary medicines
The Committee retabled amendments rejected (...)

Pharma lobbies for longer data protection periods

Pharmaceutical brand name corporations are pushing hard so that the revised EU legislation provides for prolongation of "data protection" and "commercial exclusivity" for their products.
You’ll find Medicines in Europe Forum position on this issue in the attached PDF.
For more information click here.
Related EPHA articles
Accession Countries issue declaration on EU pharma review
European pharmaceutical association makes its case to EPHA

Council supports Commission’s communication on the G10

On 22 September 2003, the Competitiveness Council adopted its own set of conclusions on reinforcing the competitiveness of the EU-based pharmaceutical industry.
These were based on the Commission’s communication of 1st July 2003 on the G10 Medicines Groups recommendations.
The Health Council is expected to adopt its own conclusions on the Commission’s G10 Communication at an upcoming meeting.
The G10 Group will continue its work until EU enlargement in May 2004.
Provisional (...)

The Cancun Ministerial conference of the WTO: What went wrong?

The Cancun ministerial conference collapsed on September 14th as Minister Derbez made the decision to halt the negotiations because of the absence of a consensus on the pending decision on the Singapore issues.
Preliminary Analysis
The following factors contributed to the failure of the mid-term review of the Doha Development round.
1- Overloaded agenda
This failure occurs after two years of missed deadlines and postponement of decisions leading to a clearly overloaded agenda. The lack of (...)

Updates from Cancun: 10 September

Daily update from Jo Leadbeater, European Health NGOs representative in Cancun.
Negotiations got underway today (10 September) at the WTO ministerial in Cancun, with agriculture continuing to dominate the official discussions and the buzz in the hallways.
The proposal by four West African countries (Benin, Burkina Faso, Mali and Chad) to eliminate US cotton subsidies continues to receive a lot of attention.
Cotton was discussed in the plenary with many developing countries expressing (...)

Joint NGO statement on TRIPS and public health

A joint NGO statement on TRIPS and public health, titled "A ’gift’ bound in red tape" (see attachment) has been issued by 14 NGOs.
The statement says that "as a measure of trade policy, [the WTO deal on medicines] contradicts the basic principles of the WTO and free trade."
It also includes an explanatory list of the main problems with the rules, and finally, two clear demands:
"We call upon the WTO member countries to draft an amendment to the TRIPS that simplifies and clarifies the (...)

Accession Countries issue declaration on EU pharma review

Health ministers of the 10 new Member States decided to issue a declaration on 5 September, on the margins of the informal meeting of EU health ministers in Milan, Italy, to draw attention to their fears over the new medicines legislation’s provisions on data exclusivity.
The Italian Presidency has stated that they want to make as much progress as possible on the pharma review package with a view to its final adoption before the impending EU enlargement in May 2004.
In the Declaration, (...)

Agreement on access to medicines

After tense and difficult negotiations, a final agreement has been reached in the WTO on access to medicines.
On Thursday 28 August, the WTO’s 146 members failed to reach a final agreement but the talks continued on Friday 29 August and a compromise was agreed. On 1st September the WTO endorsed the deal to improve access to medicines for developing countries.
All WTO Members have now agreed to the compromise text brokered last December to allow those countries without the capacity to (...)

MSF and Oxfam say WTO drugs deal is "flawed"

The WTO agreement of 30 August 2003, which is ostensibly intended to get drugs to the poorest countries, does not provide a workable solution, according to Médecins Sans Frontières (MSF) and Oxfam.
"Today’s deal was designed to offer comfort to the US and the Western pharmaceutical industry," said Ellen ’t Hoen of MSF. "Unfortunately, it offers little comfort for poor patients. Global patent rules will continue to drive up the price of medicines."
The original intention of the talks was (...)

Pose your questions on Cancun to Lamy

Europe’s chief trade negotiator Pascal Lamy will be online from 18:00 on Thursday 4th September to answer questions on the Cancun ministerial.
Click here for more infor on how to participate in the chat.

Commission Communication on the G10 Medicines Initiative

Last 1 July, the Commission adopted a Communication on the G10 Medicines initiative.
Mr Erkki Liikanen, Member of the European Commission, responsible for Enterprise and the Information Society, delivered the speech "A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient" in the presentation of the Communication to the plenary session of the European Parliament.
The Communication pursues five broad themes:
Benefits to Patients.
Developing a competitive (...)

Spotlight on tackling neglected diseases

The WHO has announced a new initiative to promote research and development into neglected diseases such as leishmaniasis (kala azar), human African trypanosomiasis (sleeping sickness), and Chagas disease, that afflict the most impoverished in developing countries.
A joint action by the Indian Council of Medical Research (ICMR), Médecins Sans Frontières (MSF) and four eminent public research institutes, the Drugs for Neglected Diseases initiative or DNDi will work in close collaboration (...)

Access to medicines: some progress at Sharm al Sheik WTO mini-Ministerial

WTO trade ministers made some progress at their ’mini-Ministerial’ meeting in Sharm-Al-Sheik (21-22 June) on the issue of access to medicines.
The ’mini-Ministerial’ gathered some 30 representatives of WTO member countries to discuss the ongoing talks on trade in the road to Cancun.
US Trade Representative Robert Zoellick told the audience that there was an ongoing dialogue with US pharmaceutical firms on the issue. Unofficial sources also reported that the US are no more pursuing their (...)

Access to Medicines: EU Clears Plan to Ensure Delivery of Cheap Medicines to Developing Countries

From EU Trade News, 26 May 2003
Today the Council adopted a regulation enabling exporters to deliver essential medicines at strongly reduced (’tiered’) prices to poor countries by making sure the goods are not diverted back to the European Union.
The regulation aims to enable producers to significantly increase supplies of medicines to combat HIV/AIDS, malaria and tuberculosis at lower, so-called ’tiered’ prices, while keeping higher prices for the same items in the EU. Exporters are (...)

Prodi Calls on US to Shift Position on Cheaper Drugs

Speaking in Brussels on 28 April 2003, Commission President Romano Prodi, asked the United States for a "positive signal" to help break the deadlock in WTO negotiations designed to improve developing countries’ access to cheap medicines.
The President told a gathering of business leaders, NGOs and politicians that the EU is "waiting for a positive signal" from Washington to end the stalemate in key WTO negotiations.
More information on Europa (...)

Affordable medicines threatened in Europe

To date the focus on access to medicines has understandably concentrated on the critical need to provide affordable medicines to developing and least developed countries. However, new EU pharmaceutical legislation presents a threat in the accession countries, which are highly dependent on non-brand name medicines at low cost, according to Greg Perry of the European Generic Medicines Association.
While the much-discussed TRIPS Agreement threatens access to medicines in the world’s poorest (...)

EU Commission Criticised for Position on Worldwide Medicine Agreement

US and Europe have still not reached an agreement on the access to cheap medicines for the world’s poorest nations. During the negotiations, the US, home to the world’s largest pharma industry, insisted that any deal must be limited both in scope and duration. On this basis, the US has been acting unilaterally and using temporary and non-binding measures, while Europe has criticised this move and has issued an alternative proposal: multilateral and permanent.
As with the original DOHA (...)