What is the future role of policy makers to facilitate better integration of hepatitis C and drug user health?

RICARDO BAPTISTA LEITE, MD, MP Medical Doctor and Member of the Portuguese Parliament Member of the Parliamentary Health Committee | Foreign Affairs Committee National Spokesperson for Health | Social Democratic Party Founder and President | ‘UNITE – Global Parliamentarians Network to End Infectious Diseases’ Vice President | ‘Parliamentary Network on the World Bank and International Monetary Fund’ Head of Public Health | Católica University of Guest Lecturer | NOVA Medical School Former Deputy Mayor of [email protected] | @RBaptistaLeite Portugal: Cascais – Sintra – Estoril Coast

@RBaptistaLeite Portugal

• Iberian Peninsula (South West Europe) • Population of 10,264,226 • Area of 91,590 km2 • Recognised for:

@RBaptistaLeite World0meters (2019). Portugal population. Available at: http://www.worldometers.info/world-population/portugal-population/ Accessed: 27/03/19 Portugal: the history behind the drug law

1926–1974 Salazar dictatorship Contributing factors include: Return of soldiers and Portuguese citizens from the colonies 1974 Democratic revolution Lack of knowledge due to the closed nature of the autocratic regime Lack of preparation for the new political and socio-economical status

Problematic consumption of drugs

@RBaptistaLeite Cabral, T. (2017). The 15th anniversary of the Portuguese drug policy: Its history, its success and its future. Drug Science, Policy and Law. https://doi.org/10.1177/2050324516683640 Portugal: the landscape of drug use pre-2001

Health and Market issues: social issues: • - number of seizures • - treatment demand and in the quantity • - infectious diseases of seized – HIV, HCV reported substances • - drug-related deaths • - LSD and ecstasy • - number of presumed availability drug offenders • - in drug prices at retail level

Heroin was the main substance of problematic drug use Increases in reported HIV infections and drug-related deaths between 1991–1998 highlighted the public health risks of heroin injecting and the need for drug policy reform @RBaptistaLeite IPDT for EMCDDA (2000) National report 2000: Portugal. EMCDDA () Available: http://www.emcdda.europa.eu/html.cfm/index34675EN.html Accessed: 22/03/19 Hughes and Stevens (2007) The effects of decriminalization of drug use in Portugal. The Beckley Foundation Drug Policy Programme. Available: https://core.ac.uk/download/pdf/91904.pdf Accessed: 21/03/19 Drug policy options

Criminalisation Depenalisation Decriminalisation Legalisation The process in which a A policy in which a criminal When the status of an The process in which a permitted legal act is case previously punished offence is reclassified from prohibited illegal act turned into a criminal can be closed without constitutionally criminal to becomes permitted legal offence by making it proceeding punishment non-criminal behaviour in the country’s illegal legal framework

@RBaptistaLeite EMCDDA. Motion graphic: What is decriminalisation of drugs? Accessed: http://www.emcdda.europa.eu/media-library/motion-graphic-what-decriminalisation-drugs_en Available: 20/03/19 2001: policy changes in Portugal

1st July 2001 Pre- 1st July 2001 st Implementation of the Post- 1 July 2001 Drug possession and use Referral to ‘Commissions Law 30/2000. were punishable criminal for the Dissuasion of Drug Decriminalisation of drug offences. Abuse’ within 72 hours. possession, acquisition, Individuals were liable to Administrative sanctions and consumption for fines or up to 3-months of can be given. imprisonment.. personal use*. .

. * ‘Personal use’ was defined as a quantity of drugs that did not exceed the average quantity that an average user consumes over a period of 10 days. Drug use is not legal in Portugal!

Hughes and Stevens (2007) The effects of decriminalization of drug use in Portugal. The Beckley Foundation Drug Policy Programme. Available: https://core.ac.uk/download/pdf/91904.pdf Accessed: 21/03/19 EMCDDA Country Legal Profiles (2012) Country legal profiles: Portugal. Available: http://www.emcdda.europa.eu/html.cfm/index5174EN.html?pluginMethod=eldd.countryprofiles&country=PT Accessed: 22/03/19 2001: policy changes in Portugal

1979 1983 1996 2001 (~100.000 Heroin Users)

DRUG RELATEDEU COMPARED IMPRISONMENTS CONSUMPTION REHAB SUCCESS RATES DRUG TOURISM

CRIME

Less than 2% are drug-related (MSW 57,5% | Source: INSA, 1983-2017 1st Dx HIV HAART Drug Addiction as MSM 36,7%) (notified cases until 15.04.2018) in Portugal Health Problem @RBaptistaLeite Main features of the Law 30/2000

Introducing a system of Ending the use of penal sanctions referral to Commissions of for drug possession Dissuasion of Drug Addiction • Regional panels made up (CDTs)of three individuals: • Police refer people who are found in o A social worker, legal advisor and possession of drugs to the CDTs medical professional o The individual appears before the CDT within • Use targeted responses to drug users 72 hours o For example: sanctions like community • Focus police resources on those who profit from services; bans to specific locations the drugs trade • Primary aim is to encourage entry into treatment or education @RBaptistaLeite Hughes and Stevens (2007) The effects of decriminalization of drug use in Portugal. The Beckley Foundation Drug Policy Programme. Available: https://core.ac.uk/download/pdf/91904.pdf Accessed: 21/03/19 Post-2001 policy changes: drug-use

Student reports of lifetime drug use between 1995–2011 • Since 2003, use of cannabis increased while use of other drugs remained relatively stable. cannabis drugs other than marijuana or hashish

18 • Rise in cannabis use corresponds to a general 16 trend seen across Europe in the late 1990s and 14 early 2000s 12 10 In 2015: • Lifetime use of cannabis and other substances were

(%) 8 slightly lower than the respective European 6 averages of 16% for cannabis and 5% for other 4 substances among students (lower by 1% for each) 2

Percentage students of 0 • Psychoactive substances were also lower than the 1995 1999 2003 2007 2011 European average of 4% (lower by 3%) @RBaptistaLeite = Introduction of the decriminalisation law ESPAD (2015) ESPAD report 2015: Results from European School Survey Project on Alcohol and Other drugs. Available: http://www.espad.org/sites/espad.org/files/ESPAD_report_2015.pdf Accessed: 27/3/19 ESPAD (2011) The 2011 ESPAD report: Substance Use Among Students in 36 European Countries. Available: http://www.espad.org/sites/espad.org/files/The_2011_ESPAD_Report_FULL_2012_10_29.pdf Accessed: 27/3/19 Post-2001: drug-related deaths

Opiates Cannabis Methadone Opiate-related deaths declined significantly 300 Cocaine Amphetamines since 2000 with other drug-related deaths remaining mostly constant 250 • Drug-induced deaths has continued to decrease 200 and stabilised between 2011 to 2016 (27 deaths in 2016). 150 • Opioids were detected in majority of these deaths Deaths 100 • In 2016: 50 o Drug-induced mortality rate within 15-64 year olds in Portugal was estimated 3.86 0 deaths per million – the European average 2000 2001 2002 2003 2004 2005 2006 was 21.8 deaths per million

= Introduction of the decriminalisation law @RBaptistaLeite EMCDDA. (2018) Portugal Drug Report 2018. Available: http://www.emcdda.europa.eu/countries/drug-reports/2018/portugal/drug-use_en Accessed: 21/03/19 Greenwald. CATO Institute. Drug Decriminalization in Portugal: Lessons for Creating Fair and Successful Drug Policies. 2009. Available https://www.cato.org/publications/white-paper/drug-decriminalization-portugal- lessons-creating-fair-successful-drug-policies Accessed: 20/03/19 Post-2001: treatment entries

Between 1999-2003: Since 2007: The number of individuals on substitution 40000 treatment in 1999 and in 2003: 30000 6,04 147 14,87 20000 01999 % 72003 in opioidin 10000treatment In 2016: substitution

All treatment entrants by primary drug: Number of clients 0 2007 2009 2010 2012 2013 2014 2015 2016

Heroin Cannabis The number of opioid substitution clients decreased in Cocaine Other 2010 and 2013, and has not increased since

EMCDDA. (2018) Portugal Drug Report 2018. Available: http://www.emcdda.europa.eu/countries/drug-reports/2018/portugal/drug-use_en Accessed: 21/03/19 Tavares, et al (2005) External and Independent Evaluation of the “National Strategy for the Fight Against Drugs” and of the “National Action Plan for the Fight Against Drugs and Drug Addiction – Horizon 2004”, Portuguese @RBaptistaLeite National Institute of Public Administration, Lisbon. Post-2001: drug-related crime

Dealer User Dealer/ User Sentenced dealers decreased from 2003 whilst 2400 users were no longer sentenced to prison from 2001 2000

1600 • The proportion of drug-related offenders* in the prison population also declined: 1200

800 44% 21% 400 Individuals Sentenced 1999 2012 2000 2001 2002 2003 2004 2005 2006 * defined as those who committed offences under the influence of drugs and/or to fund drug consumption)

@RBaptistaLeite Murkin. TRANSFORM. Drug decriminalisation in Portugal: setting the record straight. 2014. Available: https://transformdrugs.org/wp-content/uploads/2018/10/Portugal_0.pdf Accessed: 20/03/19 Greenwald. CATO Institute. Drug Decriminalization in Portugal: Lessons for Creating Fair and Successful Drug Policies. 2009. Available https://www.cato.org/publications/white-paper/drug-decriminalization-portugal- lessons-creating-fair-successful-drug-policies. Accessed: 20/03/19 Decriminalisation: Perspectives from PWUDs (I)

Factors that still need to be considered:

The shift of labelling PWUDs are still PWUDs from susceptible to fines if ‘criminals’ to they do not attend medicalised dissuasion People who use drugs ‘patients’ has led to appointments which can (PWUDs) still stigmatisation as sick Widespread availability mandate attendance at experience and unaccountable or peer distribution of involuntary harassment, violence for personal naloxone is not rehabilitation and discrimination from decisions. available. programmes. services and the police for Drug consumption possession of any rooms are also not amount of drugs established.

Levy. INPUD. (2018) Is Decriminalisation Enough? Drug User Community Voices from Portugal. Available: http://www.inpud.net/sites/default/files/Portugal_decriminalisation_final_online%20version%20- %20RevisedDec2018.pdf Accessed: 20/03/19 @RBaptistaLeite Decriminalisation: Perspectives from PWUDs (II)

Factors that still need to be considered:

Despite being safer than People are concerned of other countries, people the potential toxic are still required to contaminants present in enter dangerous, their drugs due to the lack The small amounts deemed clandestine of legal drug for personal use may not production and Harm Reduction environments to services are still not be sufficient for obtain their drugs unregulated drug personal use for markets available in prison everyone – this causes settings. Prison MD’s them to run legal risks are not allow to prescribe DAA’s.

Levy. INPUD. (2018) Is Decriminalisation Enough? Drug User Community Voices from Portugal. Available: http://www.inpud.net/sites/default/files/Portugal_decriminalisation_final_online%20version%20- %20RevisedDec2018.pdf Accessed: 20/03/19 @RBaptistaLeite @RBaptistaLeite HIV in Portugal 2011 | HIV Resolution

@RBaptistaLeite 2011 | HIV, Hep and TB Resolution

@RBaptistaLeite 2010–2014: the Portuguese financial crisis

Austerity measures set-out by TROIKA (the European Commission, European Central Bank and International Monetary Fund) were feared to negatively impact harm reduction services set up by the 2001 policy change

100 600 TROIKA TROIKA 3-year 500 3-year 80 programme programme

related 400 - 60 300 diagnoses 40 Number of HIV

deaths 200

20 100

0 0 Number of drug 2008 2009 2010 2011 2012 2013 2014 2015 2016 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 The number of drug-related deaths and drug-associated HIV diagnoses continued to decrease

@RBaptistaLeite EMCDDA. (2018) Portugal Drug Report 2018. Available: http://www.emcdda.europa.eu/countries/drug-reports/2018/portugal/drug-use_en Accessed: 21/03/19 HCV in Portugal The Tipping Point

February 2015

@RBaptistaLeite HCV in Portugal The Tipping Point

February 2015

@RBaptistaLeite @RBaptistaLeite HCV in Portugal The Tipping Point

“DON’T LET ME DIE!” José Carlos Saldanha

@RBaptistaLeite Hepatitis C: Policy in Action HCV | When Research meets Policy

The Ministry of Health announced an agreement with Gilead Sciences and DAA’s were fully funded for all February 2015 patients with Hepatitis C.

Risk sharing model was adopted. The Ministry agreed on paying per patient that is clinically cured (not per number of weeks of treatment nor per number of patients treated) and the payment procedures were fully centralized.

Volume-based agreement: Price paid is inversely proportional to the number of patients treated.

Centralized registry database was commissioned and is currently used by physicians.

National Action Plan for Hepatitis C and the review of the national HCV treatment guidelines were prepared by a @RBaptistaLeite panel of experts. Hepatitis C: Policy in Action Hepatitis C in Portugal

Today

Over 25,309 patients that have been diagnosed with chronic HCV in the NHS and their treatment has been authorised

23,394 patients have initiated treatment (>1/3 estimated population living with chronic Hep C)

14,023 PATIENTS CURED

96.5% SVR Ministry of Health. National programme for viral hepatitis. Available at: https://www.dgs.pt/documentos-e- publicacoes/relatorio-do-programa-nacional-para-as-hepatites-virais-2017.aspx (20 August 2019); @RBaptistaLeite Hepatitis C: Policy in Action Hepatitis C in Portugal

Health Outcomes @13.000

Averted Gained Averted Savings 3.477 premature 62.869 life years 339 liver transplants, 271.4 million Euros on liver related deaths 1.951 liver cancers, treatment costs related to 5.417 cases of chirosis hepatitis c complications

Source: Tato Marinho R, Rodrigues J, Paula Martins A, Andreozzi V, Vandewalle B, Félix J, Castro Alves E, Mota-Filipe H. Long-Term Effect of the Portuguese Universal Access Program to New Generation Direct-Acting Antivirals for Treatment of Hepatitis C. EASL 2016, Barcelona, Poster #SAT-178. @RBaptistaLeite A new model for purchasing medicines and other Health technologies? @RBaptistaLeite ‘Give’ politicians what they need Getting Political Leaders to push for Health

1. Relevance. Align the policy with an issue of public concern.

2. Effectiveness. Demonstrate how it makes a difference with before-and-after data. Incremental milestones.

3. Affordability. Show them how much money it will save – or at least how little it will cost. And where the money comes from.

4. Timeliness. Plan implementation to show results when they need them – e.g., in time for the next election.

@RBaptistaLeite Development of novel harm-reduction tools in Portugal

Let’s end HEPC’ – A research project by the Portuguese Catholic University

Interactive policy tool to The aim is to support The initial stage includes help stakeholders and forecast potential 6 countries: understand the potential policy changes based Austria, Bulgaria, Portugal, on expected outcomes to Romania, Spain, and England affects of various support Hepatitis C political decisions on the elimination by 2030 evolution of Hepatitis C

@RBaptistaLeite Let’s end HepC (2017) Available: http://www.letsendhepc.com/about.html Accessed: 27/03/10 CHANGING POLICY. TOGETHER.

A digital tool that integrates the analysis of the history of disease, the treatment continuum, vulnerable populations and the impact of health policies

LETSENDHEPC.COM and download the APP ‘LET’S END HEPC’ DECLARATION OF INTERESTS Gilead Sciences Europe Ltd is providing financial support for this project to UCP. @RBaptistaLeite COMPARING POLICIES ACROSS COUNTRIES

LETSENDHEPC.COM and download the APP ‘LET’S END HEPC’ @RBaptistaLeite ASSESSING AND FORESEEING IMPACT

POLICY IMPACT ON HEALTH OUTCOMES

Main HCV Outcomes Per Year 2019-2030 Vulnerable Populations

LETSENDHEPC.COM and download the APP ‘LET’S END HEPC’ @RBaptistaLeite REDESIGNING THE FUTURE

POLICY CALCULATOR ‘Gamification of Policy Making’

LETSENDHEPC.COM Download the APP

‘LET’S END HEPC’ @RBaptistaLeite PUBLIC HEALTH POLICY TOOL

POLICY CALCULATOR ‘Gamification of Policy Making’

LETSENDHEPC.COM Download the APP

‘LET’S END HEPC’ @RBaptistaLeite 6 UNITE Global Eastern Europe 38 and Central Western and Asia 0 Parliamentarians Central India Network Europe

10 UNITE REGIONAL CHAPTERS 1 China 101 MEMBERS* 3 FROM 5 Western and 52 COUNTRIES Central North Africa America

6 19 16 Eastern and Asia and Central, South 2 Pacific America & the Southern Middle East Caribbean Africa and North Africa

*See Annex I: UNITE MPs It’s time to end HIV/AIDS, Viral Hepatitis and other Infectious Diseases. It’s time to UNITE.

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