Euro Brief
1-15 July 2005, No. 13/2005
Mandelson urged to stop US moves to water down access to Aids drugs deal
ECJ confirms EU allowed to go ahead with vitamin ban plan
Generics take on patented drug giants over Paediatric directive
Kyprianou welcomes council agreement on health claims
Committee ready to move on REACH chemicals directive
Mandelson urged to stop US moves to water down access to Aids drugs deal
EU Commissioner for Trade, Peter Mandelson, has been urged to take on the US after signs that the Americans are putting pressure on sub-Saharan States to sign up to bilateral agreements which forbid them from using cheaper generic medicines in the fight against HIV and AIDS.
The French AIDS organisation, ACT-UP Paris gave its support to a Report from the European Parliament which calls for action from the Commission against US bilateral trade agreements with developing countries, known as WTO Plus Agreements.
ACT-UP believes that WTO Plus agreements ride roughshod over a deal reached at the 2001 World Trade Organisation (WTO) Summit. The 2001 deal allowed developing countries to override drug patents to make medicines (both patented and generic) more accessible for the poor.
The US bilateral agreements creates new monopolies on medicines so governments cannot bypass drug patents where necessary to protect public health. Some countries such as Chile and Morocco have already signed away their rights. Now the US has Botswana, Lesotho, Namibia, South Africa and Swasiland in its sights. Up to 42% of the population of these countries are infected with the AIDS virus.
Mandelson is being urged to make a statement ahead of the WTO General Council in late July.
ECJ confirms EU allowed to go ahead with Vitamin ban plan
The European Court of Justice has delivered a surprise ruling in favour of an EU Regulation which tightens up safety regulations for food supplements containing minerals and supplements.
The Regulation, which was adopted in 2002 and due to come in to force in August this year, will require vitamin -makers to reformulate many of their products.
The Commission's European Food Safety Authority in Palma, Italy will now begin work checking the safety of food supplements. If they are found unsafe, they will be removed from the shelves. Businesses are calling for a derogation that would allow their products to remain on the shelves while they are undergoing safety tests, expected to come to an end in September 2009.
The Ruling unusually went against a preliminary opinion given by the ECJ Advocate General in April.
Generics take on patented drug giants over Paediatric directive
The patented pharmaceutical industry is fighting to keep a 6 month patent extension offer from the Commission. The Commission's proposal to extend patents by 6 months to products that have been developed specifically for children has met fierce opposition from the generic medicines industry.
The draft Paediatric Regulation will force companies to run trials on certain medicines under patent, as well as future medicines coming on-patent in order to produce paediatric formulae. The companies will be given a six month patent extension as compensation.
However this could mean a windfall of up to 500million Euro for a blockbuster drug, says the generic industry. Cost estimates for running the trials for children vary between 1 and 4 million Euro.
French Centre-Right MEP, Francoise Grosstete MEP is responsible for the European Parliament Report. MEPs in the influential Environment and Health Committee voted on the Grosstete Report on the 14th July. They want the Commission to review the regulation after six years and amend it if it is not producing results. In addition Members of the committee want a special EU research programme specifically for children - called the Medicines Investigation for the Children of Europe (MICE). The Report will go to the full Parliament for a vote in Strasbourg in September.
Kyprianou welcomes council agreement on health claims
Markos Kyprianou, the Commissioner for Health and Consumer Protection has welcomed the unanimous political agreement by the Council of Health Ministers on the Commission's proposed Health and Nutrition Claims Regulation.
The backing from the Health Council is a huge boost for the Commissioner in his struggle with the European Parliament over the MEPs rejection of the proposed clause 4, which provides for harmonised rules for the use of health/nutritional claims on food products based on nutrient profiles. Ministers also back requirements for health claims about disease reduction to be authorised based on scientific evidence.
Kyprianou said, "The proposal endorsed by Ministers guarantees citizens clear, truthful and reliable information on the food they are eating".
The proposed Regulation lays down strict conditions for the use of clams such as "low fat", "high fibre" or "reduced sugar"
On 26 May, MEPs kicked out the controversial clause four at the centre of the Regulation. Clause four is based on the principle that the use of claims is conditional on respecting the overall nutrient profile of the food. Also, scientific claims such as "good for your heart" would have to be authorised by the European Food Safety Authority (EFSA) before they could be used.
While the Commission accepted a number of parliamentary amendments in part or whole after the May First Reading, it rejected the deletion of clause four and the amendment replacing authorisation with a notification procedure. However, Commission Opinions are non-binding. It is the recent Council's Common Position that has forced the legislation to enter Second Reading.
The draft Regulation will now start its Second Reading against a back-ground of a high-profile European Commission healthy-lifestyles strategy. The Commission is high-lighting studies - such as the recent BMA study that show the prevalence of childhood obesity is growing at a rate of 25% in some EU regions and that about 400,000 children are becoming obese or overweight every year.
Committee ready to move on REACH chemicals directive
The European Parliament's Environment and Health Committee is finally ready to end months of deliberation over the controversial REACH directive.
REACH - the Registration, Evaluation and Authorisation of CHemicals has been dogged by delays by studies and cost assessments supported by the chemicals industry which is ferociously campaigning against the legislation.
The Parliamentary Report drafted by Italian Socialist MEP Guido Sacconi calls for a European Chemicals Agency. REACH shifts the responsibility to make available information on hazards and risk-reduction measures for chemicals is shifted away from Government to industry.
The Rapporteur Sacconi has focused on reducing animal testing and the Agency.
The Committee had originally earmarked a vote to take place in September but is now aiming for adoption of the Report to take place on 3-4 October with a view to a First Reading in plenary on 14-17 November in time for the Competitiveness Council at the end of November.