Tag Archives: Medicine

Orphan medicinal products

Orphan medicinal products

Outline of the Community (European Union) legislation about Orphan medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Orphan medicinal products

Document or Iniciative

European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products [See amending act(s)].

Summary

As a result of the high cost of research and development, the pharmaceuticals industry is reluctant to develop medicinal products intended for the treatment of rare conditions, as well as those called ‘orphan medicinal products’, for which the market is smaller. The aim of this Regulation is to establish a Community procedure for designating orphan medicinal products and to introduce incentives for orphan medicinal products research, development and marketing, for example by granting exclusive marketing rights for a ten-year period.

Orphan medicinal product: criteria for designation

A medicinal product must be designated an orphan medicinal product:

  • if it is intended for the diagnosis, prevention or treatment of a condition affecting no more than five per ten thousand persons in the Community;
    if it is intended for treating a serious or debilitating disease and it is unlikely that without incentives marketing it would generate sufficient return to justify the necessary investment.

Committee for Orphan Medicinal Products

A ‘Committee for Orphan Medicinal Products’, set up within the European Medicines Agency, is responsible for assessing the applications for a medicinal product to be designated an orphan medicinal product and to deliver an opinion to the Commission which makes the decision concerning the designation of a medicinal product as an orphan medicinal product. The Regulation gives the sponsor of the medicinal product the possibility of appealing against the Committee’s opinion. Medicinal products designated as orphan medicinal products are entered on the ‘Community Register of Orphan Medicinal Products’.

Marketing authorisation procedure

Orphan medicinal products are mandatorily subject to the ‘centralised’ marketing authorisation procedure provided for in Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use. The sponsor of an orphan medicinal product can be exempted from payment of the fees payable to the European Medicines Agency.

Exclusive marketing rights

Where marketing authorisation is granted in respect of an orphan medicinal product, the latter will enjoy, with certain exceptions and limitations, exclusive marketing rights for a ten-year period. However, at the request of a Member State, this period can be reduced to six years if that Member State can establish that the conditions justifying the designation as an orphan medicinal product are no longer met or that the price being charged for the medicinal product in question is excessive.

Other incentives

Orphan medicinal products can be eligible for further incentives made available by the Commission and the Member States to support the research, development and availability of orphan medicinal products. More particularly, the measures aid research in favour of small and medium sized enterprises. Member States must inform the Commission of measures taken to this end. The Commission must publish a regular inventory detailing the incentives introduced by the Community and the Member States.

Committee

The Commission shall be assisted by the Permanent Committee for Medicinal Products for Human Use established by Directive 2001/83/EC.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation EC No 141/2000

22.1.2000

OJ L 18 of 22.1.2000

Amending act(s) Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation EC No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 141/2000 have been incorporated in the original text. This consolidated version is of documentary value only.

Related Acts

 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) [Official Journal L 136 of 30.04.2004].

This Regulation amends, improves and replaces Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Commission Regulation (EC) No 847/2000 of 27 April 2000, laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ [Official Journal L 103 of 28.04.2000].

Improved medical treatment on board vessels

Improved medical treatment on board vessels

Outline of the Community (European Union) legislation about Improved medical treatment on board vessels

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Employment and social policy > Health hygiene and safety at work

Improved medical treatment on board vessels

Document or Iniciative

Council Directive 92/29/EEC of 31 March 1992 on the minimum safety and health requirements for improved medical treatment on board vessels [See amending acts].

Summary

Each Member State shall take the necessary measures to ensure that:

  • every vessel * flying its flag or registered under its plenary jurisdiction always carries on board medical supplies * which meet, in terms of quality, the specifications of Annex II for the category of vessel to which it belongs;
  • the quantities of medicinal products and medical equipment depend on the nature of the voyage, the activities, the cargo and the number of workers *;
  • the contents of the supplies are detailed on a checklist corresponding to the framework laid down in Annex IV;
  • every vessel carries a watertight medicine chest for each of its lifeboats (the contents of these medicine chests must be detailed on the checklist);
  • every vessel of more than 500 gross registered tonnes, with a crew of 15 or more workers and engaged on a voyage of more than three days, has a sick-bay in which medical treatment can be administered;
  • every vessel with a crew of 100 or more workers, engaged on an international voyage of more than three days, has a doctor on board.

Antidotes

Any vessel carrying dangerous substances must have medical supplies including antidotes * (Annex II) appropriate to the danger presented by such substances; in principle, all antidotes are carried on ferry-type vessels, since the nature of the dangerous substances transported on these vessels is not always known well enough in advance. The contents of the supplies must be detailed on a checklist.

Responsibilities

The provision and replenishment of the medical supplies are the responsibility of the owner * and are undertaken exclusively at his expense. Responsibility for the management of the supplies lies with the captain. They must be kept in good condition.

Information and training

The Directive provides that the medical supplies must be accompanied by information and training measures to ensure that medical treatment is given correctly:

  • the medical supplies must contain a guide to their use;
  • maritime vocational training must include basic training in medical and emergency measures;
  • the captain and any worker or workers to whom he delegates the use of the medical supplies must receive special medical training in accordance with the general guidelines set out in Annex IV.

Medical consultations by radio

The Member States shall designate centres which hold the necessary data to ensure better emergency treatment for workers. Personal data of a medical nature held by these centres shall remain confidential.

Medical supplies must be inspected annually.

Technical changes to the Annexes shall be adopted by the Commission or, if necessary, the Council, with the assistance of a committee composed of representatives of the Member States.

Background

The purpose of this Directive is to improve medical treatment at sea, since a vessel is a workplace which, on account of its mobility and its geographical isolation, presents heightened risks to the safety and health of the workers on board.

Key terms used in the act
  • Vessel: any vessel flying the flag of a Member State, or registered in a Member State, sea-going or estuary-fishing, excluding inland navigation vessels, warships, pleasure boats and tugs operating in harbour areas (vessels shall be classed in three categories in accordance with Annex I);
  • Medical supplies: medicines, medical equipment and antidotes listed in Annex II;
  • Worker: any person carrying out an occupation on board a vessel, excluding port pilots and shore personnel carrying out work on board a vessel at the quayside;
  • Antidote: a substance used to prevent or treat the harmful effects of the dangerous substances listed in Annex III;
  • Owner: the registered owner or, where appropriate, the demise charterer or manager of a vessel.

References

 

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 92/29/EEC

10.4.1992

31.12.1995

JO L 113 of 30.4.1992

 

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2007/30/EC

28.6.2007

31.12.2012

OJ L 165 of 27.6.2007