The purpose of this is to compensate patentees for the time during which they were not able to exploit their inventions as a result of the need to secure regulatory approval before putting the product onto the market. The regulation came into effect on 2 January 1993 for all then EEC Member States except Spain, Portugal and Greece, for which the regulation will come into effect on 2 January 1998. Typically, 12 years may elapse between discovery or invention and medicinal use, reducing the effective patent term to eight years. This situation has, the Commission says, ‘arisen as a result of the interference between two types of administrative procedure (which) imposes heavy penalties on pharmaceutical research, which is therefore discriminated against as compared with other technological sectors’. Additionally there is provision in the Community for health authorities to grant what is effectively a period of non-patent exclusivity for new drugs. This is done by the health authority agreeing for a given period not to grant approval for any generic drug unless the generic manufacturer submits all of the same test data as the initial applicant. The relevant directive provides that Member States shall provide such exclusivity for a minimum period of six years. As a practical matter, however, most have adopted a term of 10 years. Extensions of patents will be effected by the grant of ‘supplementary protection certificates’ for periods of up to five years after the end of the normal patent term. Subject to this five-year limit, extensions will be for a period of five years less than the delay occurring between the filing of the application giving rise to the patent was granted. The regulation will have retroactive effect to cover some products already on the market. In general such retroactive effect covers drugs that first obtained marketing approval on or after 1 January 1985, although different dates apply for Denmark and Germany (1 January 1988) and Belgium and Italy (1 January 1982). It should be noted that the extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject-matter that might fall within the scope of the patent claims.

1997 ◽  
pp. 295-295
Keyword(s):  
Pharmaceutical Research ◽  
New Drugs ◽  
Marketing Approval ◽  
Generic Manufacturer ◽  
Member States ◽  
Administrative Procedure ◽  
Health Authorities ◽  
Retroactive Effect ◽  
Medicinal Use ◽  
Patent Term

Health Technology Assessment

2011 ◽  
pp. 26-41
Author(s):  
Lise Lund Haheim ◽  
Berit Morland
Keyword(s):  
Information Flow ◽  
Health Professionals ◽  
Rapid Development ◽  
New Drugs ◽  
Treatment Modalities ◽  
Industrialized Countries ◽  
Scientific Publications ◽  
The Public ◽  
Health Technologies ◽  
Health Authorities

Scientific publications in medical fields are rapidly increasing and are overwhelming in numbers. This poses a challenge to health authorities, and health professionals who need knowledge to make informed decisions in finding the best evidence for treatment and practice in the health provision to the public. They need an accessible system that handle the information flow using a systematic approach. This applies to developing and industrialized countries alike. The rapid development of health technologies with the introduction of new drugs, devices, and complex treatment modalities to achieve better health outcomes increases the need for evaluation of the treatment effect. This chapter illustrates how the health service handles the information flow utilizing information technology, and the great benefit that is gained by this methodology.

scholarly journals Computational toxicology

2015 ◽  
Vol 34 (12) ◽  
pp. 1304-1309 ◽  
Author(s):  
RT Naven ◽  
S Louise-May
Keyword(s):  
Critical Role ◽  
Pharmaceutical Research ◽  
In Vitro Models ◽  
New Drugs ◽  
Data Sets ◽  
Predictive Toxicology ◽  
Drug Induced ◽  
Chemical Toxicology

Predictive toxicology plays a critical role in reducing the failure rate of new drugs in pharmaceutical research and development. Despite recent gains in our understanding of drug-induced toxicity, however, it is urgent that the utility and limitations of our current predictive tools be determined in order to identify gaps in our understanding of mechanistic and chemical toxicology. Using recently published computational regression analyses of in vitro and in vivo toxicology data, it will be demonstrated that significant gaps remain in early safety screening paradigms. More strategic analyses of these data sets will allow for a better understanding of their domain of applicability and help identify those compounds that cause significant in vivo toxicity but which are currently mis-predicted by in silico and in vitro models. These ‘outliers’ and falsely predicted compounds are metaphorical lighthouses that shine light on existing toxicological knowledge gaps, and it is essential that these compounds are investigated if attrition is to be reduced significantly in the future. As such, the modern computational toxicologist is more productively engaged in understanding these gaps and driving investigative toxicology towards addressing them.

scholarly journals Midostaurin, enasidenib, CPX-351, gemtuzumab ozogamicin, and venetoclax bring new hope to AML

Blood ◽  
2017 ◽  
Vol 130 (23) ◽  
pp. 2469-2474 ◽  
Author(s):  
Andrew H. Wei ◽  
Ing S. Tiong
Keyword(s):  
Older Patients ◽  
Myeloid Leukemia ◽  
Gemtuzumab Ozogamicin ◽  
New Drugs ◽  
Marketing Approval ◽  
Liposomal Cytarabine ◽  
Intensive Chemotherapy ◽  
Antibody Drug Conjugate ◽  
Low Intensity ◽  
Therapeutic Landscape

Abstract In 2017, 4 drugs received US Food and Drug Administration marketing approval for acute myeloid leukemia (AML) treatment: targeted therapies for mutant FLT3 and IDH2, a liposomal cytarabine-daunorubicin formulation for therapy-related AML and AML with myelodysplasia-related changes, and resurgence of an antibody-drug conjugate designed to target CD33. Promising results also emerged for the BCL-2 inhibitor venetoclax combined with low-intensity therapy in older patients unfit for intensive chemotherapy. This quintet of new drugs is likely to reshape the therapeutic landscape of AML.

scholarly journals Beyond hydroxyurea: new and old drugs in the pipeline for sickle cell disease

Blood ◽  
2016 ◽  
Vol 127 (7) ◽  
pp. 810-819 ◽  
Author(s):  
Marilyn J. Telen
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Tissue Injury ◽  
Pharmaceutical Research ◽  
New Drugs ◽  
Treatment Modalities ◽  
Cell Disease ◽  
Hemoglobin F ◽  
Fda Approval ◽  
Old Drugs

Abstract Despite Food and Drug Administration (FDA) approval of hydroxyurea to reduce the frequency of vaso-occlusive episodes, sickle cell disease (SCD) has continued to be treated primarily with analgesics for pain relief. However, elucidation of the multiple pathophysiologic mechanisms leading to vaso-occlusion and tissue injury in SCD has now resulted in a burgeoning effort to identify new treatment modalities to prevent or ameliorate the consequences of the disease. Development of new drugs as well as investigation of drugs previously used in other settings have targeted cell adhesion, inflammatory pathways, upregulation of hemoglobin F, hemoglobin polymerization and sickling, coagulation, and platelet activation. Although these efforts have not yet yielded drugs ready for FDA approval, several early studies have been extremely encouraging. Moreover, the marked increase in clinical pharmaceutical research addressing SCD and the new and old drugs in the pipeline make it reasonable to expect that we will soon have new treatments for SCD.

The Timeliness of New Drug Approvals in Canada

1995 ◽  
Vol 25 (1) ◽  
pp. 153-165 ◽  
Author(s):  
Nigel S. B. Rawson
Keyword(s):  
Recent Article ◽  
Drug Approval ◽  
The United States ◽  
Regulatory Approval ◽  
New Drugs ◽  
Marketing Approval ◽  
The Public ◽  
The United Kingdom ◽  
Anti Cancer ◽  
High Level

In a recent article, Lexchin asks “who needs faster drug approval times in Canada?” and, on the basis of extremely limited and selective data, draws the conclusion that neither the public nor the pharmaceutical industry does. Whether the Canadian system is really slower is investigated by comparing Canadian and U.S. marketing approval dates and by using information on regulatory approval times from the two countries and elsewhere. Marketing approval dates in Canada are significantly later than those in the United States, although not consistently across all therapeutic categories; anti-cancer and gastrointestinal drugs have earlier approval dates in Canada. However, Canadian and U.S. regulatory approval times are not significantly different, indicating that marketing applications are submitted later in Canada, but both are considerably longer than those in the United Kingdom. The evidence shows that Canadians need faster drug approval times if individuals requiring the medications are not to suffer unnecessarily. A significant decrease in drug approval times and the establishment of comprehensive and effective postmarketing surveillance would reduce the time it takes for new drugs to be made available to Canadians while, at the same time, providing a high level of drug safety.

scholarly journals Administrative Acts of the European Union

2018 ◽  
Vol 6 (2) ◽  
pp. 35
Author(s):  
Marek Jaśkowski
Keyword(s):  
European Union ◽  
The European Union ◽  
Present Contribution ◽  
Member States ◽  
Administrative Procedure ◽  
Administrative Act ◽  
The Individual ◽  
The Eu

In light of the transfer of the non-negligible extent of administrative competences from member states to the EU it is important not to deprive the interested individuals of legal guarantees, originally enjoyed by them under the national law of administrative procedure. Therefore, formal qualification of an act at the EU level should not result in diminishing individual procedural protection. With this assumption in mind the present contribution is intended to construe a notion of an administrative act of the European Union on the basis of national law conceptions of administrative acts. Subsequently, the article presents an analysis of various categories of EU acts in light of a uniform notion of the individual administrative act as an attempt to standardize the structures, procedures and methodologies employed in different domains of EU competence.

Are EUIPO Trade Mark Examiners and the Boards of Appeal Bound by Precedent Decisions?

2020 ◽  
Vol 69 (9) ◽  
pp. 893-901
Author(s):  
Emiliano Marchisio
Keyword(s):  
Legal Reasoning ◽  
Case Law ◽  
Trade Mark ◽  
Member States ◽  
General Duty ◽  
Administrative Procedure ◽  
Persuasive Power ◽  
Administrative Duty ◽  
Specific Duty

Abstract Are EUIPO examiners and appeal bodies bound by previous decisions of the office they belong to? Before the decision in Puma was issued, there was a succession of frequently referred to ECJ precedents which were apparently disregarded. EUIPO offices had been considered bound to the sole law (and, where precedents are concerned, only to ECJ case-law). However, after Puma, pursuant to the administrative duty to act consistently and to state the grounds on which decisions are based, it is concluded that relevance of EUIPO precedents (and of the ‘Trade mark guidelines’, as far as they are based on them) should not be set aside simply because they are not formal sources of law. Instead, they should be appreciated as rules of administrative procedure. In this sense, precedent EUIPO decisions should be recognised as more than just a persuasive power (which they share with all other relevant ‘precedents’ such as Member States case-law or offices’ decisions). In fact, it should be acknowledged that they also have a role within the duty of motivation of administrative decisions. So if EUIPO decides to depart from a precedent or from its ‘Trade mark guidelines’, explicit and detailed motivation of such departure is required. Even if the EUIPO is under a general duty to take into account the decisions already taken in respect of similar applications, a specific duty to take into consideration a given precedent requires that such precedents are duly reported with all relevant elements to be taken into consideration (factual context and legal reasoning) within the decision to be issued.

scholarly journals Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

BMJ ◽  
2020 ◽  
pp. m3434
Author(s):  
Thomas J Hwang ◽  
Joseph S Ross ◽  
Kerstin N Vokinger ◽  
Aaron S Kesselheim
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
New Drugs ◽  
European Medicines Agency ◽  
Health Authorities ◽  
Therapeutic Value ◽  
The Us ◽  
Value Association

AbstractObjectiveTo characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs.DesignRetrospective cohort study.SettingNew drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020.Data sourcesTherapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy).Main outcome measuresProportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status.ResultsFrom 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA.ConclusionsLess than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.

A philosophy for Opening Biotechnology Collaboration for Therapeutics

2017 ◽  
Author(s):  
Jason Barkeloo ◽  
Timothy Cripe ◽  
Li Guo ◽  
Ronald Laymon ◽  
Pablo Pomposiello ◽  
...  
Keyword(s):  
Synthetic Biology ◽  
Research And Development ◽  
Open Source ◽  
Patent Protection ◽  
Pharmaceutical Research ◽  
New Drugs ◽  
Regulatory Requirements ◽  
Drug Candidates ◽  
Technological Advances ◽  
Prescription Costs

The pharmaceutical industry faces a host of worsening problems: Multibillion-dollar expenses and decade-long development times to bring new drugs to market, high failure rates for new drug candidates, and a patent system that is both expensive and uncertain. Demanding regulatory requirements and governmental pressures on prescription costs add yet more pressure on drug development. Although the situation does not yet constitute a crisis, its current trajectory is becoming increasingly untenable. While the industry itself has been resourceful in introducing technological advances and operating reforms such as increased collaboration through patent pooling, these efforts do not exhaust the possibilities for improvement. In particular, there has been an emerging, more agile and responsive alternative model in pharmaceutical research and development, namely open source synthetic biology – a rapidly developing and highly collaborative effort based on engineering principles involving the design and construction of biological systems using standardized modules of DNA. Synthetic biology began entirely open to those who wished to participate, provided that they agreed to share their results without restrictions. In its current and more mature state, it retains much of its open source character and is consequently less dependent on secrecy and patent protection than the pharmaceutical industry’s largely proprietary approach. The success of open source synthetic biology has inspired us to further develop that approach for research and development in Biotechnology and its pharmaceutical applications. Here, we reviewed the history and progress of open source science and technology.

Health Technology Assessment

2011 ◽  
pp. 746-762
Author(s):  
Lise Lund Haheim ◽  
Berit Morland
Keyword(s):  
Information Flow ◽  
Health Professionals ◽  
Rapid Development ◽  
New Drugs ◽  
Treatment Modalities ◽  
Industrialized Countries ◽  
Scientific Publications ◽  
The Public ◽  
Health Technologies ◽  
Health Authorities

Scientific publications in medical fields are rapidly increasing and are overwhelming in numbers. This poses a challenge to health authorities, and health professionals who need knowledge to make informed decisions in finding the best evidence for treatment and practice in the health provision to the public. They need an accessible system that handle the information flow using a systematic approach. This applies to developing and industrialized countries alike. The rapid development of health technologies with the introduction of new drugs, devices, and complex treatment modalities to achieve better health outcomes increases the need for evaluation of the treatment effect. This chapter illustrates how the health service handles the information flow utilizing information technology, and the great benefit that is gained by this methodology.

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