WARNER-LAMBERT V ACTAVIS – DO WE HAVE AN EFFECTIVE SYSTEM FOR ENFORCING SECOND MEDICAL USE PATENTS IN THE UK? Why is this important? Increasingly, unmet medical needs are being met by "repurposing" of old medicines for new diseases. Before such medicines may be used to treat patients for the new disease, expensive research including clinical trials must usually be performed. One mechanism to incentivise this research is to grant innovator companies exclusivity for the new indications through second medical use patents. Thus, there is a public policy argument for granting second medical use patents, and to ensuring that these patents are enforceable. On the other hand, generic versions of innovative drugs should be allowed on to the
Microsoft word - 7 antidoping.rtfClub Information Manual Section 3.7 Dec 2001 Orienteering Australia Operational Manual 4.2
What do Words used in this Policy Mean? What is the Federation's Position on Doping? Who does this Policy Apply to? What is a Doping Offence? Investigation of a Doping Offence and Referral to Hearing How are Hearings Conducted? What Sanctions Apply? How long do Sanctions Apply? How wil the Federation Enforce Sanctions? Review of a Finding of a Doping Offence or a Sanction How Can a Person Appeal a Decision? Retirement and Comebacks What do Words used in this Policy Mean? In this Policy:"AIS" means the Australian Institute of Sport.
"ADCO" means the Anti-Doping Control Officer appointed by the Federation to give effect to this Policy and, if no person is appointed, the President of the Federation.
"AOC" means the Australian Olympic Committee Inc.
"ASC" means the Australian Sports Commission established by the Australian Sports Commission Act 1989.
"ASDA" means the Australian Sports Drug Agency established by the Australian Sports Drug Agency Act 1990.
"athlete" means a person who:(a) participates (whether in competition or out-of-competition) in a sporting activity conducted by or under the auspices of the Federation, or uses the facilities of the Federation.
"CAS" means the Court of Arbitration for Sport (Oceania Registry).
"Committee" means a committee established in accordance with the Rules of the IOF to conduct a hearing on a doping offence.
"drug testing authority" means:(a) an agency appointed by ASDA, the IOF or the Federation or a national drug testing operates under its own statute, rules and regulations, and has samples analysed by an IOF approved or an IOC accredited an agency which conducts testing on athletes for the detection of prohibited substances where: the methods of testing substantial y accord with IOF or IOC procedures, the sample is analysed by an IOF approved or an IOC accredited "Federation" means Orienteering Australia and includes its member and affiliated "IOF" means the International Orienteering Federation.
Club Information Manual Section 3.7 Dec 2001 "IOC" means the International Olympic Committee created by the Congress of Paris of 23 June 1894, which is entrusted with the control and development of the Modern Olympic Gamespursuant to the Olympic Charter.
a person who, or body which, is a member of the Federation, or a person who, or body which, is affiliated with the Federation, or a person who is a member of a body which is a member of or affiliated with the and includes a person taking part in, or involved in or associated with (eg as a coach, official, medical or al ied health practitioner) any sporting activity conducted, authorised orrecognised by the Federation.
"official" means a person who administers, manages, assists or is otherwise involved in the sport of the Federation other than as an athlete, coach, or medical or analogous health practitioner.
"positive test result" means a result of a test by a drug testing authority which shows the presence of a prohibited substance in a sample or the use of a prohibited method.
"prohibited method" means a method prohibited under the anti-doping policy of:(a) the IOF, or if the IOF does not have an anti-doping policy, the IOC.
"prohibited substance" means a substance prohibited under the anti-doping policy of:(a) the IOF, or if the IOF does not have an anti-doping policy, the IOC.
"recognised medical authority" means:(a) the Australian Sports Drug Medical Advisory Committee (ASDMAC) established by section 65B of the Australian Sports Drug Agency Act, or an authority recognised by the ASDMAC which may authorise the use of a prohibited substance and/or prohibited method for a therapeutic purpose.
"sample" means human biological fluid or tissue.
"testing" means the requesting, col ecting and analysis of a sample.
manufacturing, extracting, transforming, preparing, storing, expediting, transporting, importing, transiting, offering (whether subject to payment or free of charge),distributing, sel ing, exchanging, brokering, obtaining in any form, prescribing,commercialising, making over, accepting, possessing, holding, buying or acquiring in anymanner a prohibited substance(b) financing or serving as an intermediary for the finance of any of the activities in provoking in any way the consumption or use of a prohibited substance, or being knowingly concerned or involved in a prohibited method other than for personal use by a person who is not an athlete, for personal use by an athlete wherethe athlete has approval for therapeutic use, or in the course of the lawful exercise of professionalmedical, pharmaceutical or analogous activities.
Words in the singular include the plural and vice versa.
A person includes a body corporate.
What is the Federation's Position on Doping? The Federation condemns the use of performance enhancing drugs and doping practices in sport. The use of performance enhancing drugs and doping practices is contrary to the ethics ofsport and potential y harmful to the health of athletes.
Club Information Manual Section 3.7 Dec 2001 The only legitimate use of drugs in sport is under the supervision of a physician for a clinical y justified purpose.
The Federation aims to stop doping practices in sport by:(a) imposing effective sanctions on persons who commit doping offenses educating and informing persons about drugs in sport issues, and supporting the drug testing programs and education initiatives of ASDA and other drug testing authorities.
The Federation wil :(a) give ASDA timely and accurate athlete contact information support and assist ASDA to conduct doping control make this Policy available to members, athletes, coaches, officials, and medical and health practitioners(d) develop and implement, in consultation with ASDA and the IOF, drug education and information programs for athletes, coaches, officials and medical and healthpractitioners, and(e) support the initiatives of the ASC, the IOF, the IOC and the AOC to stop doping offences in sport.
Athletes and other persons may be subject to investigation and disciplined under this The Federation wil not disclose information about a person who is al eged to have, or has committed a doping offence except (for a purpose under this policy) to: the ASC or another person, until after(i) the Committee or the CAS has made a determination, or(i ) the ADCO has decided not to refer the matter to a hearing.
Who does this Policy Apply to? This Policy applies to:(a) athletes, and employees and contractors of the Federation.
What is a Doping Offence? An athlete commits a doping offence if:(a) a prohibited substance is present within the athlete's body tissue or fluids, unless:(i) the athlete uses the prohibited substance for a therapeutic purpose (see clause 5.4), or(i ) there are exceptional circumstances (see clause 5.5) the athlete uses or takes advantage of a prohibited method, unless there are exceptional circumstances (see clause 5.5), or(c) the athlete refuses to provide a sample for testing when requested by a drug testing A person (including an athlete) commits a doping offence if:(a) the person is knowingly involved in trafficking, or the person knowingly assists, or is knowingly involved in the commission of a doping offence by another person.
A doping offence is proved if a person admits to having committed the doping offence to another person.
Therapeutic PurposeA person uses a prohibited substance for a therapeutic purpose if:(a) the person had written approval prior to testing from a recognised medical authority for the therapeutic use of the prohibited substance(b) the level of the prohibited substance in the sample is consistent with the approved therapeutic use, and(c) the therapeutic use of the prohibited substance is not inconsistent with IOF rules.
Club Information Manual Section 3.7 Dec 2001 See also appendix 1.
Exceptional CircumstancesExceptional circumstances exist if the presence of the prohibited substance or the use of a prohibited method is beyond the person's control. For example: the person has a natural Testosterone : Epitestosterone ratio above 6:1, the person is administered the prohibited substance in hospital without their the prohibited method is part of emergency medical treatment.
Exceptional circumstances do not exist merely because the person:(a) took the prohibited substance or used the prohibited method inadvertently, or did not know that the substance or method was prohibited.
The onus of proof is on the person who claims that:(a) they used a prohibited substance for a therapeutic purpose, or there are exceptional circumstances.
Investigation of a Doping Offence and Referral to Hearing Where the Federation receives information that a person may have committed a doping offence, the ADCO wil investigate the matter.
The ADCO wil refer the matter to a hearing under clause 6.6 if the ADCO:(a) reasonably believes that a person may have committed a doping offence, or receives a notice from a drug testing authority of:(i) a positive test result by the person, or a refusal by the person to provide a sample.
The ADCO may decide not to refer the matter to a hearing if the person in writing:(a) acknowledges that they have committed the doping offence, and waives the right to a hearing in relation to:(i) whether the person committed a doping offence, and(i ) what sanction wil apply.
The Federation may then apply a sanction as set out in clause 8.1.
The ADCO wil :(a) inform the ASC of the details of the person and the al eged doping offence consult the ASC about their participation in any investigation and hearing, and assist in any investigation and hearing on behalf of the ASC.
The ADCO may agree to refer the matter to a hearing under clause 5.6 jointly with the ASC.
If the ADCO decides to refer the matter to a hearing, the ADCO wil send the person a letter sets out the nature and basic details of the al eged doping offence says that the ADCO wil refer the matter to a hearing within 14 days (unless the person gives a written waiver under clause 6.3), and(c) encloses a copy of this Policy.
The ADCO wil wait 14 days (or a shorter period agreed between the ADCO and the person) after sending a letter under clause 6.5 and then wil appoint: the CAS, or a Committee established in accordance with the rules of the IOF to conduct a The ADCO may withdraw the referral to a hearing under clause 6.6 at any time until the hearing commences if the person gives a written waiver under clause 6.3.
The ADCO may:(a) suspend financial or other assistance to the person, and suspend the person from competition in events and competitions conducted by or under the auspices of the Federation until the determination of the hearing.
Club Information Manual Section 3.7 Dec 2001 The Committee or the CAS wil determine:(a) whether the person has committed a doping offence, and if so what sanction wil apply, and how long the sanction wil apply.
How are Hearings Conducted? A person al eged to have committed a doping offence has a right to a hearing unless the circumstances in clause 6.3 apply.
A person who has acknowledged that they have committed a doping offence may request a hearing on sanction only.
The CAS wil conduct the hearing as set out in the Code of Sport-related Arbitration.
Where a Committee conducts the hearing, the Committee:(a) wil conduct the hearing in the manner the Committee determines wil conduct the hearing:(i) with as little formality and technicality, and as proper consideration of the matter permits may conduct the hearing by telephone or other conference facility may examine and cross-examine witnesses may appoint a legal representative or other person to assist it, and may al ow the person al eged to have committed a doping offence to(i) examine and cross-examine witnesses, and be assisted by a legal representative or other person.
The Committee or the CAS wil accept the result of a test conducted by a drug testing the drug testing authority did not substantial y comply with the applicable drug testing procedures, and(b) that noncompliance casts significant doubt on the result.
The onus of proof is on the person who claims the Committee or the CAS should not accept The Committee or the CAS wil give the ADCO a written statement of:(a) the findings of the hearing what sanction (if any) wil apply, and how long the sanction (if any) wil apply.
What Sanctions Apply? Where the Committee or the CAS determines that a person has committed a doping offence, it wil apply one or more of the fol owing sanctions.
The Committee or the CAS may:(a) ban the person from selection to represent Australia in international competition ban the person from competing in any events and competitions conducted by or under the auspices of the Federation(c) make the person ineligible to receive direct or indirect funding or assistance from the Federation(d) ban the person from holding any position within the Federation require that the person remain on ASDA's register for the purpose of out-of- competition testing(f) recommend that:(i) the Federation or require the person to repay financial assistance given to the person from the date of thedoping offence.
(g) require the person go to counseling for a specified period withdraw awards, placings and records won in events and competitions conducted by or under the auspices of the Federation from the date of the doping offence, and/or(i) reprimand the person.
Club Information Manual Section 3.7 Dec 2001 Where the Committee or the CAS determines that an employee or contractor of the Federation has committed a doping offence, the Federation wil take disciplinary action against theemployee or contractor.
Where the Committee or the CAS:(a) determines that a person has not committed a doping offence because:(i) the person used a prohibited substance for a therapeutic purpose, or there were exceptional circumstances, but considers that the person had an unfair advantage (because of the presence of the prohibited substance) in a competition or event conducted by or under the auspices of theFederation, the Committee or the CAS may disqualify the person from that competition or event and withdrawawards, records and placings won by the person in that competition or event.
How Long do Sanctions Apply ? Where the doping offence involves:(a) anabolic androgenic steroids peptide and glycoprotein hormones or analogues a prohibited method a refusal to provide a sample, or sanctions under clauses 8.1(a), (b), (c), (d) and (e) wil apply for:(a) a minimum of two years for a first doping offence, and life for a second doping offence.
In al other cases, sanctions under clauses 8.1(a), (b), (c), (d) and (e) wil apply for:(a) the period that would apply under the IOF anti-doping policy, or if the IOF anti-doping policy does not specify a period for the doping offence:(i) three months or less for a first doping offence two years for a second doping offence, and life for a third doping offence.
The Committee or the CAS may consult a recognised medical authority for assistance in interpreting a positive test result.
In an appropriate case the Committee or the CAS may vary the period in clause 9.1 or 9.2 on the basis of the recognised medical authority's interpretation and/or recommendation.
The sanction wil apply from the date of the doping offence unless the Committee or the CAS decides otherwise.
How wil the Federation Enforce Sanctions? the Federation wil enforce the sanction decided by the Committee or the CAS if the sanction is consistent with this Policy.
the Federation may appeal under clause 12.1 if the ADCO believes the sanction is inconsistent with this Policy.
the Federation wil recognise and enforce a sanction properly imposed on a person who has committed an offence under the anti-doping policy of : the IOF or another organisation recognised by the ASC where the offence would be a doping offence under this Policy.
The ADCO must inform:(a) any relevant sporting organisations the ASC and of the offence and the sanction applied by the Committee or the CAS. The ADCO may then inform other persons or organisations as the ADCO thinks Club Information Manual Section 3.7 Dec 2001 The Federation may reinstate financial or other assistance to the person which the ADCO suspended under clause 6.8.
Review of a Finding of a Doping Offence or a Sanction A person may make an application to the ADCO for review of a finding of a doping offence or a sanction where new and relevant information becomes available which was: not considered by the Committee or the CAS at the hearing, and not available to the person at the time of the hearing.
The application must:(a) be in writing, and set out the new and relevant information.
The ADCO wil consider the application and may refer the application to the Committee or the CAS to: review the finding that the person committed the doping offence, and decide whether to reduce or withdraw the sanction.
A sanction wil remain in force during the review unless the Committee or the CAS decides The ADCO must inform:(a) any relevant sporting organisations any person or organisation informed of the original determination under clause 11.4 of any change to the original determination as a result of the review.
The ADCO may then inform other persons or organisations as the ADCO thinks How Can a Person Appeal a Decision? A person (including the Federation) aggrieved by a decision under this Policy may appeal to the CAS Appeals Division.
The CAS Appeals Division wil rehear the matters appealed against as set out in the Code of Sport-related Arbitration.
A party to the appeal may:(a) appear in person (a body corporate may be represented by any of its officers), or be represented by a legal or other representative.
The decision of CAS Appeals Division wil be final and binding on the parties to the appeal.
No person (including the Federation) may institute or maintain proceedings in relation to the appealin any court or tribunal other than the CAS Appeals Division.
The sanction wil remain in force during the appeal unless CAS Appeals Division decides Retirement and Comebacks A person may retire from competition by notifying the Federation in writing.
The person's retirement date wil be the date the Federation receives the notice.
Retirement does not: excuse the person from giving a sample requested before their retirement date prevent the analysis of a sample given by the person before their retirement date affect the results of testing under (a) or (b) above, or exempt the person from this Policy in relation to a doping offence committed before their retirement date.
Club Information Manual Section 3.7 Dec 2001 A person may make a written request to the Federation for reinstatement one year after their retirement date. The request is taken to be made on the date the Federation receives therequest.
Reinstatement wil be at the discretion of the Federation. This Policy wil apply to the person from the date of their reinstatement request.
During the six month period fol owing the reinstatement request the person may be tested:(a) as required by the Federation and IOF rules, and at the discretion of ASDA.
A retired person may not compete in competitions and events conducted by or under the auspices of the Federation until the fol owing periods expire: For international competitions and events - 2 years from the date of the For domestic competitions and events - 6 months from the date of the A person may apply to the CAS Appeals Division to be eligible to compete in international competitions and events before the period set out in clause 13.8 expires.
A person may apply to the ADCO to be eligible to compete in domestic competitions and events before the period set out in clause 13.8 expires.
AdoptedDecember 2001 Club Information Manual Section 3.7 Dec 2001 Appendix1 to 4.2 (Anti-Doping Policy) Where an athlete, for therapeutic purposes, is prescribed an inhaler with a substance listed in theOlympic Movement Anti-Doping Code (OMADC) List under class I A Stimulants (Salbutamol,Salmeterol, Terbutaline and Formoterol), a declaration shal be provided by the doctor of thatathlete (in the form as shown below) to the Federation prior to use. Such declaration shal remainin effect for a period of 12 months and may be subject to review by the Federation's Medical Officer.
USE OF PROHIBITED SUBSTANCE NOTIFICATION FORM Doctor's NameContact Telephone NumberQualifications Athletes NameContact Telephone NumberAddress Name of DrugDosageReason(s) why the administration of this prohibited substance is necessary for the health of theathlete Reason(s) why a non listed drug cannot be used Doctors signatureDate Send completed form to Orienteering AustraliaPO Box 740 GLEBE NSW 2037Fax 02 9660 2067
DER REGIERUNG BETREFFEND DIE ABÄNDERUNG DES GESETZES ÜBER DIE KRANKENVERSICHERUNG (KRANKENVERSICHERUNGSGESETZ; KVG) UND WEITERER GESETZE Ministerium für Gesellschaft Das Krankenversicherungsgesetz soll mit dieser Vorlage einer umfassenden Re- form unterzogen werden. Die in den letzten Jahren sehr stark gestiegenen Kosten