Achievements

LPIA MILESTONES SINCE THE LATE EIGHTIES

 

RELATIONS WITH THE LEBANESE ORDER OF PHARMACISTS (OPL)

  • 1994: Contribution to the updating of the law ruling the practice of the profession of pharmacist # 367 dated 1/8/1994.
  • 2006 (1 Sept): Signing of a Protocol between OPL and LPIA related to the distribution of pharmaceuticals to pharmacies and the process of return/replacement of pharmaceuticals that have a specific date for use and are near to expiry.
  • 2013 (July 31): Joint action with the Lebanese Order of Pharmacists to enforce the application of the legal conditions for the sales of medicines to authorized Dispensaries.
  • 2015 (15 Oct): MOU between OPL and LPIA members who are importers of Hormones and the necessity of refraining from selling hormones to physicians.
  • 2017 (Jan): Continuing communication between OPL and LPIA to settle pending matters between pharmacies’ owners and importers/distributors.

 

LPIA INTERNAL AFFAIRS

  • 2014 (22 Dec): Approval by LPIA Extraordinary General Assembly of the draft amendment of LPIA By-laws.
  • 2015 (19 Mar): The approval by the Ministry of Labor of the draft amendment of LPIA By-Laws.
  • 2015 (Sept): Adoption of a new LPIA logo.
  • 2016 (Jan-Feb): Issuing of the new LPIA By-Laws booklet after the amendments approved by the Ministry of Labor for immediate implementation and studying of new candidates to LPIA membership.
  • 2017 (30 Sep): LPIA Workshop HORIZON 2030 held at Al Bustan Hotel with a large audience of 60 LPIA members including owners, CEOs and executive managers of the member companies. The objectives of the workshop were to communicate the vision of the board to the members, to initiate a brainstorming among members and to end up with a list of recommendations. A short video, an executive summary and a list of Ad Hoc committees initiated by the workshop are available at LPIA website.

 

REGISTRATION OF PHARMACEUTICALS

  • 2003: Law No. 530 dated 21/7/2003, ruling the conditions of registering, importing, marketing and classifying pharmaceuticals.
  • 2008: Applicative Decree # 571 dated 23/10/2008 (Law# 530 dated 21/7/2003 and Law # 367 dated 1/8/1994).
  • 2013 (10 Oct): Creation of a committee in charge of updating Applicative Decree # 571 for Variations Type I & II and the registration conditions of Biosimilars (Decision # 1638/1).
  • 2014 (3 Oct): Contributing with the Ministry of Public Health in the preparation of the final draft of the Guidelines of the National Regulations for Biosimilars in Lebanon (Requirements and Guidance for the Registration).
  • 2015 (24 June): MOH Memo # 114, in relation with Decision # 293/1 dated February 16, 2015, about the documents required for the re-registration of pharmaceuticals.
  • 2015 (31 July): MOH Decision #1343/2 about the guidelines to prepare the technical file of pharmaceuticals registration (the active ingredient quality, the finished product quality, the bioequivalence).
  • 2017 (7 Sep): MOH Memo # 105, stopping for a 2nd year the registration of any generic having more than 6 similar in the market.
  • 2017 (2 Oct): MOH Decision # 1782/1, related to the Re-registration of Pharmaceuticals (Generics).

 

PRICING OF PHARMACEUTICALS

  • 1988: Updating the mechanism of setting the foreign currency price indicator applied on pharmaceuticals that became recurrent every 15 days.
  • 2005-2006: Updating of the pricing conditions of pharmaceuticals (Formerly Pricing Decision # 208/1 dated 3 May 1983):
    • Pricing Decision #306/1 dated 3/6/2005
    • Pricing Decision #51/1 dated 24/1/2006
  • 2013 (5 Sept): Pricing Decision # 728/1, ruling the pricing conditions of generics and locally manufactured medicines.
  • 2014 (17 April): Pricing Decision #796/1, that modified the pricing conditions including provisions that came unfair to the importers and pharmacists.
  • 2014 (19 Aug): LPIA administrative recourse to the Ministry of Public Health asking for an amendment of Pricing Decision # 796/1.
  • 2014 (17 Dec): LPIA recourse at the Council of State to invalidate the implicit decision of the Ministry of Public Health to refuse to respond to LPIA administrative recourse dated 19/8/2014.
  • 2016 (29 Feb): MOH Memo # 20 that provided for: 
    • Shortening the delay to align the authorized price in Lebanon to the level of the reference price in the country of origin from 6 months to 10 weeks,
    • Requesting the alignment of the authorized price in Lebanon if possible to the level of the reference price in the reference countries within 18 months,
    • Maintaining the frequency of re-pricing at 5 years, provided re-pricing takes place at the beginning of the fifth year.
  • 2018 (21 Feb): MOH Minister pricing decision # 301/1 that modified the pricing structure of category A (the part concerning the pharmacist) and E (the part concerning the importer).

 

IMPORTATION/EXPORTATION

  • 2002: Setting conditions on parallel imports.
  • 2008: Contribution to the awareness campaign against counterfeit medicines.
  • 2015 (4 Dec): MOH Decision # 2257/2 amending the authorization conditions for the Import/Export of: Pharmaceuticals for scientific research, lab reagents, human/animal blood and tissue samples and other biological samples.

 

LPIA HOLOGRAM: AN UNBROKEN CHAIN OF RESPONSIBILITIES

  • 2004: Introducing Hologram on pharmaceuticals bearing the names of LPIA and the importing company member of LPIA, as well as the slogan "From the producer to the citizen", giving an additional guarantee to the market that pharmaceuticals bearing LPIA Hologram are imported through an unbroken chain of responsibilities directly from the Producer to the citizen.
  • Consecutive media campaigns: 2006, 2009, 2013, 2014, 2015, 2016, 2017, 2018.

 

DISTRIBUTION TO DISPENSARIES

  • 2014 (17 May): MOH Decision #977/1 related to the conditions that should be applied when supplying pharmaceuticals to Dispensaries.

 

GOOD STORAGE & DISTRIBUTION PRACTICES

  • 2013 (Oct 9): Issuing of the Document “Good Storage and Distribution Practices” (Decision #1637/1).
  • 2014 (July 3): MOH Decision #962/1 regarding the Good storage and distribution of pharmaceuticals in Lebanon.
  • 2015 (July-October): MOH Decisions #1167/2 dated July 13th 2015 and # 2124/1 dated October 8th 2015, in relation with the procedures of applying the “Good Storage & Distribution Practices” (GSDP) Guide and issuing the “audit and conformity certificate” for the pharmaceutical establishments.
  • 2015 (November): Organizing several meetings between LPIA and the Higher Institute of Business Administration in Beirut (ESA) to develop working procedures/timeline for the issuance of the audit and conformity certificate related to GSDP.
  • 2017 (10 Feb): LPIA Participation to the Ceremony organized at the ESA Business School to present the results of the GSDP audit conducted on all Pharmaceutical Establishments.

 

SUBSTITUTION OF PHARMACEUTICALS/UNIFIED MEDICAL PRESCRIPTION

  • 2015 (February-March): Contributing to the public opinion awareness campaign outlining the importance of the application of Articles 46 and 47 of Law #367 (the practice of the profession of pharmacist), amended by Law #91 dated 6/3/2010, which set the conditions under which the pharmacist is authorized to substitute a medicine prescribed by a physician.
  • 2017 (18 February): MOH Minister Ghassan Hasbani Memo#14 calling pharmacists to favor a locally manufactured generic when using their right for substitution.

 

CODE OF ETHICS

  • 2004: Contribution to the setting of a Lebanese version of the Code of pharmaceutical marketing practices.
  • 2014 (April): Working with the Committee in charge of updating 2004 version to be in line with the global requirements of the pharmaceutical sector and to address the gaps that accumulated in the market and adjust them in a consensual and indisputable way.
  • 2016 (January): Agreement on the final version of the Code of Ethical standards for pharmaceutical promotion in Lebanon, and monitoring and accountability mechanisms.
  • 2016 (31 May): Signing of the Code of Ethical Standards for Pharmaceutical Promotion by all stakeholders at the Grand Serail in the presence of the Minister of Public Health of the President of the Council of Ministers.
  • 2016 (21 July): MOH Decision # 1356/1 forming the Review Board & the Professional Supervision Committee (the latter includes LPIA representative) that are responsible for the implementation of the Code of Ethics in Lebanon.
  • 2017 (4 Apr): Circular Letter # 34 of MOH Director General, reminding all stakeholders to abide by the provisions of the Lebanese Code of Ethics for the Promotion of Pharmaceuticals.
  • 2017 (16 Oct): MOH Minister decision # 1950/1 authorizing the Advertising of Pharmaceutical-Like Products (Class I / II) list of which can be downloaded from MOH website. Followed by MEMO # 150 dated 19 Dec clarifying its application.

 

BAR CODE

  • 2007: LPIA start studying the project of introducing a Barcode on all imported and locally manufactured pharmaceuticals.
  • 2009-2010: Joining the task force created by the Ministry of Administrative Reforms to introduce a national Barcode on all imported and locally manufactured pharmaceuticals.
  • 2015-2016: Reactivation by MOH of the project of the National Barcode and intensifying meetings between the ministry and stakeholders, in order to update the existing study and finalize it to move on to the execution phase.
  • 2017 (18 April): In a letter to LPIA, MOH DG Dr. Walid Ammar announces the launching of a PILOT Project with a limited number of stakeholders among Importers /Distributors, Pharma Wholesalers, Pharmacies, Hospitals, and Public Institutions.
  • 2017 (20 June): MOH Decision # 1134/1 & 2017 (2 Oct): MOH Decision # 1817/1 creating an advisory/technical committee for the Barcode Project including LPIA.
  • 2017 (11-14 Dec): MOH Decisions: # 2405/1, # 2428/1, # 2429/1 in relation with the pilot test, the implementation and the timeline of the 2D matrix Barcode Project.
  • 2018 (9 Jan): MOH Training session for the parties participating to the Pilot Test.
  • 2018 (2 Feb): Introducing MOH Barcode Module (user name, password, user guide).
  • 2018 (14 Mar): Meeting of the advisory/technical committee. Progress report and main challenges.

 

DESTRUCTION OF PHARMACEUTICAL WASTE

  • 2002: Shipment of 90 tons of expired pharmaceuticals to France for destruction.
  • 2004: Being part of the task force that aims at finding an environmentally accepted way of destroying expired pharmaceuticals in Lebanon.
  • 2008: Presentation of the final version of the project of co-processing pharmaceutical waste at Holcim Kilns together with its related Environmental Impact Assessment (EIA).
  • 2009-2010: Joining the inter-ministerial committee created by the Ministry of Public Health and the Ministry of Environment to study the problem of pharmaceutical waste and give recommendations on the project of co-processing pharmaceutical waste at Holcim kilns.
  • 2012 (17 Sept): Signature of an MOU between The Ministry of Environment, the Ministry of Public Health, LPIA, HOLCIM, ECOLIB and the international company APAVE listing the terms and conditions of undertaking a PILOT TEST for co-processing pharmaceutical waste at HOLCIM kilns in Lebanon under APAVE monitoring.
  • 2012 (1-3 Oct): Conducting the PILOT TEST for co-processing pharmaceutical waste.
  • 2012 (12 Dec): APAVE report showing satisfactory results of the PILOT TEST.
  • 2013 (27 Feb): MOE Decision # 58/1 about a License to HOLCIM for co-processing pharmaceutical waste in its kilns in Lebanon under the supervision of the Ministry of Environment and the Ministry of Public Health.
  • 2014 (25 Nov): MOE Decision # 392/1 renewing of the License given to HOLCIM for coprocessing pharmaceutical waste in its kilns.
  • 2015 (May-July): Working with the Committee formed by the Mohafez of Northern Lebanon to study the conditions that must be adopted to give the Mohafez administrative approval to the implementation of MOE Decision # 392/1. The result was that the Mohafez refrained from giving his administrative approval.
  • 2015 (10 July): MOH Memo # 118 concerning the storage of the Expired Cytotoxics and their resultant waste in an environmentally safe manner to be later exported for destruction when finding a country where the operation for such drugs category can be accomplished in a proper way.
  • 2016-2017(May): On-going negotiations to sign an MOU between MOH, LPIA, the Cypriot company Advanced Medical Waste Management and the Lebanese company SOLUTION, which will set the conditions and operational framework for the export of the Lebanese pharmaceutical waste to Cyprus for destruction.
  • 2017(23 Nov): Signature of an MOU between MOH, LPIA, the Cypriot company Advanced Medical Waste Management and the Lebanese company SOLUTION, regarding the export of the Lebanese pharmaceutical waste to Cyprus for destruction (for more details, visit LPIA website).

 

VARIOUS INTERVENTIONS IN MEDIA

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WORKSHOPS AND CONGRESSES

  • 1998 (6 June): For the celebration of the 50th anniversary of its foundation, LPIA organized a Workshop on "New trends in the international pharmaceutical industry and its implications on Lebanon," to initiate a collective thinking and extensive discussions about the most important issues facing the pharmaceutical industry and from different aspects: Research and development , Intellectual property rights, Globalization, National industry, Generics, self-medication medicines, Food supplements, Health Economy, Counterfeit pharmaceuticals, classification and registration regulations, Control and Inspection, the role of importers, physicians and pharmacists.
  • 2008 (8 Oct): Presentation by LPIA President of the Pricing conditions on pharmaceutical products during a seminar organized by the company "First Protocol" at Beit El Tabib.
  • 2008 (11 Dec): LPIA Workshop on Applicative Decree No. 571 Date 23/10/2008 related to the conditions of registration and importation of pharmaceutical products.
  • 2011 (June): Contributing to the creation of “the Arab Forum of Health Industries” (Health Insight) in Lebanon.
  • The “Health Insight” was held successively:  2012 (16-17 May), 2013 (April 24 – 26), 2014 (27-28 March), 2015 (23- 24 April), 2016 (2-3 June), 2017 (11-12 May), 2018 (April).
  • 2016 (10 Nov): Presentation by LPIA President of the “Pharmaceutical and Medical Market in Lebanon” during theLebanese Korean Business Forum organized by the Chamber of Commerce, Industry and Agriculture of Beirut & Mount Lebanon.
  • 2017 (10 July): LPIA Participation to the Event of the Beirut International Healthcare Industry Forum (BIHIF) organized by the Ministry of Health and Al-Iktissad Wal-Aamal Group held at Phoenicia Hotel that aimed at promoting Lebanon as a medical tourism destination, introducing the latest developments in medical technologies and providing an insight about the future of healthcare services.
  • 2018 (23 April): LPIA Participation to “Future Health” forum, the second edition of BIHIF at Hilton Beirut Metropolitan.

 

FOREIGN RELATIONS

  • 2008 (3 Apr): Presentation of LPIA president at the Federation of the French pharmaceutical industries (GEIP / LEEM) in Paris.
  • 2013 (10 Apr): The participation of LPIA President to the seminar “Health in Lebanon” organized by the Lebanese-French Chamber of Commerce in Paris.
  • 2014 (6 Mar): Presentation of LPIA president for the second time at the Federation of the French pharmaceutical industries (GEIP / LEEM) in Paris.
  • 2014 (April): Visit of a delegation from the Islamic Republic of Iran to LPIA including the pharmaceutical manufacturers and other stakeholders in the pharmaceutical sector to discuss how to develop the bilateral business relations between Iran and Lebanon in the pharmaceutical sector.
  • 2016 (1 Dec): Presentation of LPIA president at the Federation of the French pharmaceutical industries (GEIP / LEEM) in Paris.
  • 2016 (7 Dec): Second Visit at LPIA of a delegation from the Islamic Republic of Iran to continue the discussions about developing the bilateral business relations between the two countries in the pharmaceutical sector.

 

FOLLOW-UP WORK

  • Continuous update of the laws and regulations on the registration, pricing, importation, marketing and distribution of pharmaceuticals in order to keep up with the continual developments in the pharmaceutical industry internationally and locally, in collaboration with the Ministry of Public Health and the Lebanese Order of Pharmacists and the two Lebanese Orders of Physicians.
  • Finding a suitable and sustainable solution for the destruction of the pharmaceutical waste.
  • Adoption of a 2D-Data Matrix National Barcode on all imported and locally manufactured pharmaceuticals.
  • Urging Public Authorities to prevent the entry of smuggled or counterfeit pharmaceuticals or any not be in conformity with the law and its regulations.
  • Setting a basis for a strong and fruitful public/private partnership, taking into consideration international professional criteria and aiming at consolidating the relation between the public sector and the pharmaceutical manufacturers (Originators and Generics).