Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
According to data, among the 25 EU member states, approximately 100 million people belong to the pediatric population, accounting for 20% of the total population. More than 50% of the drugs used by children in Europe are either unauthorized or untested for pediatric use.
In recent years, adverse drug reactions related to children and adolescents have been increasing, leading to heightened discussions about pediatric drug use. This highlights that the pediatric population is often overlooked during the development of general medications, making them a relatively vulnerable group.
To improve children's health and encourage the development of medicines suitable for pediatric use, the European Medicines Agency (EMEA) held an expert roundtable forum in 1997, establishing a consensus on the need to strengthen relevant regulations.
Subsequently, at the end of 2000, the European Commission, referencing the EU's orphan drug regulations and relevant U.S. legislation, began revising pharmaceutical regulations.
On September 29, 2004, the EU proposed a draft regulation on pediatric medicines, titled "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004" (hereinafter referred to as the draft).
The draft applies to pharmaceutical products under development or already on the market, regardless of intellectual property protection, and allows for the invocation of relevant promotional measures.
In terms of industry obligations, the draft requires pharmaceutical companies to develop pediatric investigation plans before applying for pediatric use of a drug, ensuring that trial data meets the needs of children.
Additionally, the EU needs to establish a Pediatric Committee within the EMEA, whose main tasks include assessing whether pediatric investigation plans comply with relevant regulations, providing opinions and recommendations, supporting the establishment of an information exchange network by regulatory authorities, and offering consultations to the committee or regulatory authorities on pediatric drug use.
However, in addition to focusing on the safety of pediatric drug use, providing incentives for companies to invest in additional pediatric clinical trials has become a crucial aspect of the regulatory design.Pediatric Orphan Drug Clinical Trials with 12-Year Market Exclusivity
Therefore, in the draft, the EU has specifically designed an incentive mechanism, granting an additional six months of validity for the "Supplementary Protection Certificate" (SPC) to drugs that conduct clinical trials specifically for children and comply with the relevant provisions of the draft.
It is hoped that this will encourage pharmaceutical companies to proactively conduct relevant clinical trials. The aforementioned SPC refers to a market exclusivity right granted by the EU to compensate patent drug manufacturers for the loss of patent validity and benefits due to government policies.
Additionally, orphan drugs that conduct additional clinical trials for the pediatric population can extend their market exclusivity from 10 years to 12 years.
After the draft was released, it received much applause. However, due to the differing opinions between the European Parliament and the European Council, a series of negotiations began after the draft was proposed.
It was not until June 1, 2006, that the European Parliament finally reached an agreement with the Council and the Commission, officially passing the pediatric drug regulations.
Pediatric Drugs Can Choose One of Two Incentive Methods
Since the officially passed pediatric drug regulations are the result of negotiations, several provisions differ from the original draft. The more important ones include:
(1) Special requirements for members of the pediatric drug committee to exercise their authority independently in the public interest and to have no financial or other interests with the pharmaceutical industry.
(2) To ensure the continuous provision of safe and effective pediatric drugs, the original marketing authorization holder who benefits from compliance with the regulations must transfer the authorization or allow a third party to use the trial data protected by data exclusivity if they no longer intend to continue selling pediatric drugs.
Additionally, the original marketing authorization holder must notify the EMEA of their intention within six months before deciding to stop sales, allowing the EMEA to inform the public.
(3) Article 10 of the EU Human Medicinal Products Directive (Directive 2001/83/EC and Directive 2004/27/EC) stipulates that if a drug is found to have a new therapeutic indication based on significant trial data and is better than the existing therapy, its data exclusivity can be extended by one year.
Therefore, when an existing drug is found to be more effective for the pediatric population, it can gain an additional year of data exclusivity, thus allowing pediatric drugs to receive repeated incentives (data exclusivity and SPC). To avoid this situation, the regulations require that pediatric drugs can only apply for one of the two incentive methods.
Enhancing Public Health and Industry Development Simultaneously
The news of the European Parliament passing the pediatric drug regulations was immediately praised by the pharmaceutical industry. However, some organizations focused on social issues saw it as another scheme to fill the pockets of pharmaceutical companies.
For example, the secondary group within the European Parliament, "The Greens/European Free Alliance," believes that ensuring the safety of drugs for the pediatric population is the obligation of pharmaceutical companies and that no additional incentives are needed to encourage relevant clinical trials. This move will further burden the national health care system.Undoubtedly, the EU's regulations on pediatric medications are absolutely in the public interest and necessary. For a long time, children have not been the primary target of drug development, and with the frequent occurrence of pediatric drug-related incidents in recent years, governments around the world have begun to take this neglected public health issue seriously, leading to legislative amendments.
The EU's approach of establishing regulations while providing incentives raises the question of whether it can simultaneously ensure public health and industrial development interests, which is worth watching.
The goals of pediatric medication regulations are:
(1) To promote the development of pediatric medicines; (2) To ensure that medicines used in children undergo high-quality research processes; (3) To ensure that the use of pediatric medicines is properly authorized; (4) To improve information on pediatric medications; (5) To avoid unnecessary pediatric clinical trials while achieving the aforementioned goals, and to ensure that related trials comply with the EU Clinical Trials Directive (Directive 2001/20/EC), among others.
Sources:
1. http://www. europarl. europa. eu/ oeil/ file. jsp? id=5210532
2. http:/ / www. euractiv. com/ en/ h……ines- children/ article- 132015
3. Biotech and Medical Device Report, Issue 66, December 2004, Encouraging the Development of Pediatric Medications: EU Amends Related Pharmaceutical Regulations, by Zheng Shian.
[Biotech and Medical Device Report Monthly, September Issue]
Source: http:/ / mag. udn. com/ mag/ newss……storypage. jsp? f_ART_ID=44984
50% of Drugs Not Confirmed Safe for Children
In recent years, adverse drug reactions related to children and adolescents have been increasing, leading to heightened discussions about pediatric drug use. This highlights that the pediatric population is often overlooked during the development of general medications, making them a relatively vulnerable group.
To improve children's health and encourage the development of medicines suitable for pediatric use, the European Medicines Agency (EMEA) held an expert roundtable forum in 1997, establishing a consensus on the need to strengthen relevant regulations.
Subsequently, at the end of 2000, the European Commission, referencing the EU's orphan drug regulations and relevant U.S. legislation, began revising pharmaceutical regulations.
On September 29, 2004, the EU proposed a draft regulation on pediatric medicines, titled "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004" (hereinafter referred to as the draft).
The draft applies to pharmaceutical products under development or already on the market, regardless of intellectual property protection, and allows for the invocation of relevant promotional measures.
In terms of industry obligations, the draft requires pharmaceutical companies to develop pediatric investigation plans before applying for pediatric use of a drug, ensuring that trial data meets the needs of children.
Additionally, the EU needs to establish a Pediatric Committee within the EMEA, whose main tasks include assessing whether pediatric investigation plans comply with relevant regulations, providing opinions and recommendations, supporting the establishment of an information exchange network by regulatory authorities, and offering consultations to the committee or regulatory authorities on pediatric drug use.
However, in addition to focusing on the safety of pediatric drug use, providing incentives for companies to invest in additional pediatric clinical trials has become a crucial aspect of the regulatory design.Pediatric Orphan Drug Clinical Trials with 12-Year Market Exclusivity
Therefore, in the draft, the EU has specifically designed an incentive mechanism, granting an additional six months of validity for the "Supplementary Protection Certificate" (SPC) to drugs that conduct clinical trials specifically for children and comply with the relevant provisions of the draft.
It is hoped that this will encourage pharmaceutical companies to proactively conduct relevant clinical trials. The aforementioned SPC refers to a market exclusivity right granted by the EU to compensate patent drug manufacturers for the loss of patent validity and benefits due to government policies.
Additionally, orphan drugs that conduct additional clinical trials for the pediatric population can extend their market exclusivity from 10 years to 12 years.
After the draft was released, it received much applause. However, due to the differing opinions between the European Parliament and the European Council, a series of negotiations began after the draft was proposed.
It was not until June 1, 2006, that the European Parliament finally reached an agreement with the Council and the Commission, officially passing the pediatric drug regulations.
Pediatric Drugs Can Choose One of Two Incentive Methods
Since the officially passed pediatric drug regulations are the result of negotiations, several provisions differ from the original draft. The more important ones include:
(1) Special requirements for members of the pediatric drug committee to exercise their authority independently in the public interest and to have no financial or other interests with the pharmaceutical industry.
(2) To ensure the continuous provision of safe and effective pediatric drugs, the original marketing authorization holder who benefits from compliance with the regulations must transfer the authorization or allow a third party to use the trial data protected by data exclusivity if they no longer intend to continue selling pediatric drugs.
Additionally, the original marketing authorization holder must notify the EMEA of their intention within six months before deciding to stop sales, allowing the EMEA to inform the public.
(3) Article 10 of the EU Human Medicinal Products Directive (Directive 2001/83/EC and Directive 2004/27/EC) stipulates that if a drug is found to have a new therapeutic indication based on significant trial data and is better than the existing therapy, its data exclusivity can be extended by one year.
Therefore, when an existing drug is found to be more effective for the pediatric population, it can gain an additional year of data exclusivity, thus allowing pediatric drugs to receive repeated incentives (data exclusivity and SPC). To avoid this situation, the regulations require that pediatric drugs can only apply for one of the two incentive methods.
Enhancing Public Health and Industry Development Simultaneously
The news of the European Parliament passing the pediatric drug regulations was immediately praised by the pharmaceutical industry. However, some organizations focused on social issues saw it as another scheme to fill the pockets of pharmaceutical companies.
For example, the secondary group within the European Parliament, "The Greens/European Free Alliance," believes that ensuring the safety of drugs for the pediatric population is the obligation of pharmaceutical companies and that no additional incentives are needed to encourage relevant clinical trials. This move will further burden the national health care system.Undoubtedly, the EU's regulations on pediatric medications are absolutely in the public interest and necessary. For a long time, children have not been the primary target of drug development, and with the frequent occurrence of pediatric drug-related incidents in recent years, governments around the world have begun to take this neglected public health issue seriously, leading to legislative amendments.
The EU's approach of establishing regulations while providing incentives raises the question of whether it can simultaneously ensure public health and industrial development interests, which is worth watching.
The goals of pediatric medication regulations are:
(1) To promote the development of pediatric medicines; (2) To ensure that medicines used in children undergo high-quality research processes; (3) To ensure that the use of pediatric medicines is properly authorized; (4) To improve information on pediatric medications; (5) To avoid unnecessary pediatric clinical trials while achieving the aforementioned goals, and to ensure that related trials comply with the EU Clinical Trials Directive (Directive 2001/20/EC), among others.
Sources:
1. http://www. europarl. europa. eu/ oeil/ file. jsp? id=5210532
2. http:/ / www. euractiv. com/ en/ h……ines- children/ article- 132015
3. Biotech and Medical Device Report, Issue 66, December 2004, Encouraging the Development of Pediatric Medications: EU Amends Related Pharmaceutical Regulations, by Zheng Shian.
[Biotech and Medical Device Report Monthly, September Issue]
Source: http:/ / mag. udn. com/ mag/ newss……storypage. jsp? f_ART_ID=44984